Cognitive ImpairmentNCT05746390
Home Alone: An Intervention for People With Cognitive Impairment Who Live Alone
A study testing Home Alone in people with Cognitive Impairment and Dementia, run by University of Minnesota at 1 site in United States.
Trial summary
The goal of this clinical trial is to evaluate a program for adults who live alone and have some cognitive impairment (CI) to see if it is useful and acceptable. This program aims to help older adults with cognitive impairment who live alone to be engaged and active, as well as safe at home. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Cognitive Impairment, Dementia, Memory Loss
- What is being tested?
- Home Alone
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2023to 29 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 55 years of age or older
- Lives alone in a non-residential setting
- Either 1) provider diagnosis of MCI, 2) Montreal Cognitive Assessment by telephone (T-MoCA) score between 13 and 18, and/or 3) subjective endorsement of memory impairment on screening
- Resides in the US
- Demonstrates capacity to consent
Who cannot join
- Those who do not meet the inclusion criteria above are not eligible. Additionally, researchers would exclude those who:
- Live in assisted living, a group care home, or similar residential setting that provides care and services
- Are not English speaking
- Are currently participating in any other type of service that provides one-to-one psychosocial consultation or independent living coaching
- Have a new or worsening mental health condition and are not receiving ongoing treatment
- Have not remained on a stable psychotropic medications dosage, such as antidepressants, anxiolytics, or anti-psychotics, for the prior three months
- Are not willing/interested in participating or cannot actively participate in the intervention, per researcher discretion
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: Home Alone: Developing a Home-Based Intervention for People With Cognitive Impairment Who Live Alone
The goal of this clinical trial is to evaluate a program for adults who live alone and have some cognitive impairment (CI) to see if it is useful and acceptable. This program aims to help older adults with cognitive impairment who live alone to be engaged and active, as well as safe at home. The investigators want to see how useful this program is and how it can be improved.
The specific aims are:
Read more
- Specific Aim 1: Develop and Adapt Home Alone to Prepare for Pilot Testing.
- Specific Aim 2: Pilot Test a Revised Version of Home Alone.
Phase I participants will be asked to:
- Participate for 3 months
- Complete 3 surveys
- Complete 7 1-hour meetings on a weekly basis with a coach
- Complete a final interview
Phase II participants will be asked to:
- Participate for 6 months
- Complete 3 surveys
- Complete 7 1-hour meetings on a weekly basis with a coach
- A sub-sample will be asked to complete a final interview
Read the detailed description
The primary goal of this proposal is to establish the feasibility, acceptability, and appropriateness of a novel intervention, "Home Alone." Home Alone will be targeted to older persons with CI or Mild Cognitive Impairment (MCI) who live alone in the community. This National Institute on Aging (NIA) Stage I effort will adapt and tailor established, evidence-based mental health and dementia care intervention models (behavioral activation, Skills2Care®, Tailored Activity Program) to reduce environmental stress and enhance engagement in desired activities to improve social well-being and maintain cognition and function for those who live alone with CI. Relying on a robust, mixed methods strategy and an implementation science lens at the outset of intervention development, the investigators seek to position Home Alone as a scalable program that, as its efficacy and effectiveness is determined in subsequent trials, is primed for widespread dissemination and adoption in home-based and community contexts.
The Specific Aims are as follows:
Specific Aim 1 (Phase I): Develop and Adapt Home Alone to Prepare for Pilot Testing. The investigators will identify treatment components and examine feasibility and relevance by obtaining insights from 15 persons with CI who live alone and participate in the Home Alone intervention over a 3-month period. The investigators will utilize the Phase I period to determine whether various elements of Home Alone (e.g., delivery mode, length, and other intervention characteristics) require adaptation. The investigators will use a convergent parallel mixed methods design (i.e., the collection and analysis of quantitative and qualitative data concurrently) when doing so. Through analysis of the various quantitative and qualitative data elements to inform adaptation, the investigators will finalize and refine Home Alone prior to project Phase II (Specific Aim 2).
Specific Aim 2 (Phase II): Pilot Test a Revised Version of Home Alone. This R21 project will evaluate the following indices of implementation potential over a 6-month period: whether Home Alone is carried out as intended and is feasible (the degree to which Home Alone can be successfully delivered); acceptable (Home Alone is agreeable and satisfactory among users), and useful (participants perceive benefit from the Home Alone intervention). A sequential explanatory mixed methods design (a quantitative component followed by a qualitative component) will be utilized to pilot test Home Alone. The investigators will enroll 50 persons living alone with CI over a 6-month period. The investigators will also examine whether key empirical outcomes (perceived loneliness; activity engagement; measures of cognition and functional dependence) change over a 6-month period. Available qualitative data will provide information on how and why Home Alone was beneficial or not for persons with CI and allow for greater understanding of the intervention's mechanisms of benefit.
Home Alone combines Behavioral Activation (BA) with other evidence-based intervention approaches (i.e., Tailored Activity Program (TAP); Skills2Care®) that target the environment in order to tailor activity that is fulfilling and meaningful to persons with CI. An additional intervention component that will be incorporated in Home Alone includes environmental assessments that help the person with CI by removing objects and improving lighting and safety in areas of the home where a desired and meaningful activity will be conducted.
- Conditions
- Cognitive Impairment, Dementia, Memory Loss
- Being tested
- Home Alone
- Medical subject headings
- Cognitive Dysfunction, Dementia, Memory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home AloneBehavioural
See Home Alone description.
| Study group | Role | What they receive |
|---|---|---|
| Home Alone Intervention | Experimental | Home Alone is a semi-structured intervention, tailored to address the individual needs and concerns of the older adult. The participant will engage in about seven psychoeducational coaching sessions, each lasting approximately one hour.
The intervention has two key foci:
1. increasing or maintaining home safety and comfort
2. increasing scheduled social engagements and activities.
Sessions are also designed to identify formal and informal services and supports to improve to increase assistance and ability to live independently for as long as safely possible. The sessions take place either in-person or remotely (via secure video conferencing or telephone). Ad hoc/ongoing sessions may be provided as needed. Receives: Behavioral: Home Alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of Intervention
Acceptability of Intervention Measure - 4 item scale evaluating program acceptability. The measure evaluates the likeability of the intervention (e.g. I like the intervention; I welcome the intervention; the intervention meets my approval; the intervention is appealing to me). Items are rated on a scale of agreement (completely disagree, disagree, neither agree or disagree, agree, completely agree). Scores range from 4-20, with higher scores indicating higher levels of acceptability.
Measured: Phase I at 1 month
Acceptability of Intervention
Acceptability of Intervention Measure - 4 item scale evaluating program acceptability. The measure evaluates the likeability of the intervention (e.g. I like the intervention; I welcome the intervention; the intervention meets my approval; the intervention is appealing to me). Items are rated on a scale of agreement (completely disagree, disagree, neither agree or disagree, agree, completely agree). Scores range from 4-20, with higher scores indicating higher levels of acceptability.
Measured: Phase I at 3 months
Acceptability of Intervention
Acceptability of Intervention Measure - 4 item scale evaluating program acceptability. The measure evaluates the likeability of the intervention (e.g. I like the intervention; I welcome the intervention; the intervention meets my approval; the intervention is appealing to me). Items are rated on a scale of agreement (completely disagree, disagree, neither agree or disagree, agree, completely agree). Scores range from 4-20, with higher scores indicating higher levels of acceptability.
Measured: Phase II at 3 months
Acceptability of Intervention
Acceptability of Intervention Measure - 4 item scale evaluating program acceptability. The measure evaluates the likeability of the intervention (e.g. I like the intervention; I welcome the intervention; the intervention meets my approval; the intervention is appealing to me). Items are rated on a scale of agreement (completely disagree, disagree, neither agree or disagree, agree, completely agree). Scores range from 4-20, with higher scores indicating higher levels of acceptability.
Measured: Phase II at 6 months
Feasibility of Intervention
Feasibility of Intervention Measure - 4 item scale evaluating program feasibility; The measure includes four statements about the feasibility of intervention implementation (ex. the intervention seems implementable; the intervention seems doable; the intervention seems possible; the intervention seems easy to use). Items are rated on a five-point scale (completely disagree, disagree, neither agree or disagree, agree, completely agree). Scores range from 4-20. Higher scores indicate greater feasibility.
Measured: Phase I at 1 month
Feasibility of Intervention
Feasibility of Intervention Measure - 4 item scale evaluating program feasibility; The measure includes four statements about the feasibility of intervention implementation (ex. the intervention seems implementable; the intervention seems doable; the intervention seems possible; the intervention seems easy to use). Items are rated on a five-point scale (completely disagree, disagree, neither agree or disagree, agree, completely agree). Scores range from 4-20. Higher scores indicate greater feasibility.
Measured: Phase I at 3 months
Feasibility of Intervention
Feasibility of Intervention Measure - 4 item scale evaluating program feasibility; The measure includes four statements about the feasibility of intervention implementation (ex. the intervention seems implementable; the intervention seems doable; the intervention seems possible; the intervention seems easy to use). Items are rated on a five-point scale (completely disagree, disagree, neither agree or disagree, agree, completely agree). Scores range from 4-20. Higher scores indicate greater feasibility.
Measured: Phase II at 3 months
Feasibility of Intervention
Feasibility of Intervention Measure - 4 item scale evaluating program feasibility; The measure includes four statements about the feasibility of intervention implementation (ex. the intervention seems implementable; the intervention seems doable; the intervention seems possible; the intervention seems easy to use). Items are rated on a five-point scale (completely disagree, disagree, neither agree or disagree, agree, completely agree). Scores range from 4-20. Higher scores indicate greater feasibility.
Measured: Phase II at 6 months
Intervention Appropriateness
Intervention Appropriateness Measure - 4 item scale evaluating program appropriateness; The measure includes four statements about the feasibility of intervention implementation (ex. the intervention seems fitting; the intervention seems suitable; the intervention seems applicable; the intervention seems liked a good match). Items are rated on a five-point scale (completely disagree, disagree, neither agree or disagree, agree, completely agree). Scores range from 4-20. Higher scores indicate greater appropriateness.
Measured: Phase I at 1 month
Intervention Appropriateness
Intervention Appropriateness Measure - 4 item scale evaluating program appropriateness; The measure includes four statements about the feasibility of intervention implementation (ex. the intervention seems fitting; the intervention seems suitable; the intervention seems applicable; the intervention seems liked a good match). Items are rated on a five-point scale (completely disagree, disagree, neither agree or disagree, agree, completely agree). Scores range from 4-20. Higher scores indicate greater appropriateness.
Measured: Phase I at 3 months
Intervention Appropriateness
Intervention Appropriateness Measure - 4 item scale evaluating program appropriateness; The measure includes four statements about the feasibility of intervention implementation (ex. the intervention seems fitting; the intervention seems suitable; the intervention seems applicable; the intervention seems liked a good match). Items are rated on a five-point scale (completely disagree, disagree, neither agree or disagree, agree, completely agree). Scores range from 4-20. Higher scores indicate greater appropriateness.
Measured: Phase II at 3 months
Intervention Appropriateness
Intervention Appropriateness Measure - 4 item scale evaluating program appropriateness; The measure includes four statements about the feasibility of intervention implementation (ex. the intervention seems fitting; the intervention seems suitable; the intervention seems applicable; the intervention seems liked a good match). Items are rated on a five-point scale (completely disagree, disagree, neither agree or disagree, agree, completely agree). Scores range from 4-20. Higher scores indicate greater appropriateness.
Measured: Phase II at 6 months
Intervention Treatment Receipt
Intervention Treatment Receipt Checklist Measure - Eleven item checklist designed for study, measuring whether the coach delivered key aspects of the intervention. The measure includes 10 Likert scale items and one open-ended question on the appropriateness and acceptability of Home Alone and the extent to which Home Alone helps participants with CI modify their environment, engage in pleasant activities, and access social and other resources. The 10 items are scored on a 5 point Likert scale with a total score ranging from 0-50, where higher scores indicate greater treatment fidelity and acceptability of the intervention.
Measured: Phase I at 1 month
Intervention Treatment Receipt
Intervention Treatment Receipt Checklist Measure - Eleven item checklist designed for study, measuring whether the coach delivered key aspects of the intervention. The measure includes 10 Likert scale items and one open-ended question on the appropriateness and acceptability of Home Alone and the extent to which Home Alone helps participants with CI modify their environment, engage in pleasant activities, and access social and other resources. The 10 items are scored on a 5 point Likert scale with a total score ranging from 0-50, where higher scores indicate greater treatment fidelity and acceptability of the intervention.
Measured: Phase I at 3 months
Intervention Treatment Receipt
Intervention Treatment Receipt Checklist Measure - Eleven item checklist designed for study, measuring whether the coach delivered key aspects of the intervention. The measure includes 10 Likert scale items and one open-ended question on the appropriateness and acceptability of Home Alone and the extent to which Home Alone helps participants with CI modify their environment, engage in pleasant activities, and access social and other resources. The 10 items are scored on a 5 point Likert scale with a total score ranging from 0-50, where higher scores indicate greater treatment fidelity and acceptability of the intervention.
Measured: Phase II at 3 months
Intervention Treatment Receipt
Intervention Treatment Receipt Checklist Measure - Eleven item checklist designed for study, measuring whether the coach delivered key aspects of the intervention. The measure includes 10 Likert scale items and one open-ended question on the appropriateness and acceptability of Home Alone and the extent to which Home Alone helps participants with CI modify their environment, engage in pleasant activities, and access social and other resources. The 10 items are scored on a 5 point Likert scale with a total score ranging from 0-50, where higher scores indicate greater treatment fidelity and acceptability of the intervention.
Measured: Phase II at 6 months
Secondary outcomes (60)
Social Well-being/Loneliness (Social contact and Support)
Lubben Social Network Scale-6 6 item scale evaluating social engagement; Items assess social contact and support including family and friends; Scores range from 0 to 30, with higher scores representing more social engagement.
Measured: Phase I at baseline
Social Well-being/Loneliness (Social contact and Support)
Lubben Social Network Scale-6 6 item scale evaluating social engagement; Items assess social contact and support including family and friends; Scores range from 0 to 30, with higher scores representing more social engagement.
Measured: Phase I at 1 month
Social Well-being/Loneliness (Social contact and Support)
Lubben Social Network Scale-6 6 item scale evaluating social engagement; Items assess social contact and support including family and friends; Scores range from 0 to 30, with higher scores representing more social engagement.
Measured: Phase I at 3 months
Social Well-being/Loneliness (Social contact and Support)
Lubben Social Network Scale-6 6 item scale evaluating social engagement; Items assess social contact and support including family and friends; Scores range from 0 to 30, with higher scores representing more social engagement.
Measured: Phase II at baseline
Social Well-being/Loneliness (Social contact and Support)
Lubben Social Network Scale-6 6 item scale evaluating social engagement; Items assess social contact and support including family and friends; Scores range from 0 to 30, with higher scores representing more social engagement.
Measured: Phase II at 3 months
Social Well-being/Loneliness (Social contact and Support)
Lubben Social Network Scale-6 6 item scale evaluating social engagement; Items assess social contact and support including family and friends; Scores range from 0 to 30, with higher scores representing more social engagement.
Measured: Phase II at 6 months
Social Well-being/Loneliness (Loneliness)
De Jong Gierveld Loneliness Scale (Short - 6 items) will measure emotional and social loneliness; Scores range from 1-6. Higher scores indicate greater levels of loneliness.
Measured: Phase I at baseline
Social Well-being/Loneliness (Loneliness)
De Jong Gierveld Loneliness Scale (Short - 6 items) will measure emotional and social loneliness; Scores range from 1-6. Higher scores indicate greater levels of loneliness.
Measured: Phase I at 1 month
Social Well-being/Loneliness (Loneliness)
De Jong Gierveld Loneliness Scale (Short - 6 items) will measure emotional and social loneliness; Scores range from 1-6. Higher scores indicate greater levels of loneliness.
Measured: Phase I at 3 months
Social Well-being/Loneliness (Loneliness)
De Jong Gierveld Loneliness Scale (Short - 6 items) will measure emotional and social loneliness; Scores range from 1-6. Higher scores indicate greater levels of loneliness.
Measured: Phase II at baseline
Social Well-being/Loneliness (Loneliness)
De Jong Gierveld Loneliness Scale (Short - 6 items) will measure emotional and social loneliness; Scores range from 1-6. Higher scores indicate greater levels of loneliness.
Measured: Phase II at 3 months
Social Well-being/Loneliness (Loneliness)
De Jong Gierveld Loneliness Scale (Short - 6 items) will measure emotional and social loneliness; Scores range from 1-6. Higher scores indicate greater levels of loneliness.
Measured: Phase II at 6 months
Social Well-being/Loneliness (Well-being)
Geriatric Depression Scale-Short Form -15 items measuring emotional well-being; scores range from 0-15; Scores under 5 indicate that depression is unlikely, scores of 5 or more suggest depression.
Measured: Phase I at baseline
Social Well-being/Loneliness (Well-being)
Geriatric Depression Scale-Short Form -15 items measuring emotional well-being; scores range from 0-15; Scores under 5 indicate that depression is unlikely, scores of 5 or more suggest depression.
Measured: Phase I at 1 month
Social Well-being/Loneliness (Well-being)
Geriatric Depression Scale-Short Form -15 items measuring emotional well-being; scores range from 0-15; Scores under 5 indicate that depression is unlikely, scores of 5 or more suggest depression.
Measured: Phase I at 3 months
Social Well-being/Loneliness (Well-being)
Geriatric Depression Scale-Short Form -15 items measuring emotional well-being; scores range from 0-15; Scores under 5 indicate that depression is unlikely, scores of 5 or more suggest depression.
Measured: Phase II at baseline
Social Well-being/Loneliness (Well-being)
Geriatric Depression Scale-Short Form -15 items measuring emotional well-being; scores range from 0-15; Scores under 5 indicate that depression is unlikely, scores of 5 or more suggest depression.
Measured: Phase II at 3 months
Social Well-being/Loneliness (Well-being)
Geriatric Depression Scale-Short Form -15 items measuring emotional well-being; scores range from 0-15; Scores under 5 indicate that depression is unlikely, scores of 5 or more suggest depression.
Measured: Phase II at 6 months
Activity/Engagement
Pleasant Events Schedule: Alzheimer's Disease (AD) short form - 20 activity items measured on a scale divided into two parts. The first part of the scale measures frequency of participation and availability of the event (ltems are rated from 0 to 2; total scores can range from 0 to 40). The second part of the scale assesses current and/or past enjoyment of those activities (ltems are rated from 0 to 1; total scores can range from 0 to 20). Higher scores indicate higher levels of activity on both subscales.
Measured: Phase I at baseline
Activity/Engagement
Pleasant Events Schedule: Alzheimer's Disease (AD) short form - 20 activity items measured on a scale divided into two parts. The first part of the scale measures frequency of participation and availability of the event (ltems are rated from 0 to 2; total scores can range from 0 to 40). The second part of the scale assesses current and/or past enjoyment of those activities (ltems are rated from 0 to 1; total scores can range from 0 to 20). Higher scores indicate higher levels of activity on both subscales.
Measured: Phase I at 1 month
Activity/Engagement
Pleasant Events Schedule: Alzheimer's Disease (AD) short form - 20 activity items measured on a scale divided into two parts. The first part of the scale measures frequency of participation and availability of the event (ltems are rated from 0 to 2; total scores can range from 0 to 40). The second part of the scale assesses current and/or past enjoyment of those activities (ltems are rated from 0 to 1; total scores can range from 0 to 20). Higher scores indicate higher levels of activity on both subscales.
Measured: Phase I at 3 months
Activity/Engagement
Pleasant Events Schedule: Alzheimer's Disease (AD) short form - 20 activity items measured on a scale divided into two parts. The first part of the scale measures frequency of participation and availability of the event (ltems are rated from 0 to 2; total scores can range from 0 to 40). The second part of the scale assesses current and/or past enjoyment of those activities (ltems are rated from 0 to 1; total scores can range from 0 to 20). Higher scores indicate higher levels of activity on both subscales.
Measured: Phase II at baseline
Activity/Engagement
Pleasant Events Schedule: Alzheimer's Disease (AD) short form - 20 activity items measured on a scale divided into two parts. The first part of the scale measures frequency of participation and availability of the event (ltems are rated from 0 to 2; total scores can range from 0 to 40). The second part of the scale assesses current and/or past enjoyment of those activities (ltems are rated from 0 to 1; total scores can range from 0 to 20). Higher scores indicate higher levels of activity on both subscales.
Measured: Phase II at 3 months
Activity/Engagement
Pleasant Events Schedule: Alzheimer's Disease (AD) short form - 20 activity items measured on a scale divided into two parts. The first part of the scale measures frequency of participation and availability of the event (ltems are rated from 0 to 2; total scores can range from 0 to 40). The second part of the scale assesses current and/or past enjoyment of those activities (ltems are rated from 0 to 1; total scores can range from 0 to 20). Higher scores indicate higher levels of activity on both subscales.
Measured: Phase II at 6 months
Cognition
Telephone Montreal Cognitive Assessment (T-MoCA) - measure assessing 8 areas of cognition used over the phone to screen for Mild Cognitive Impairment; scores range from 0-22; with higher scores indicating better cognitive functioning. Scores 18 or below suggest mild cognitive dysfunction.
Measured: Phase I at screening
Cognition
Telephone Montreal Cognitive Assessment (T-MoCA) - measure assessing 8 areas of cognition used over the phone to screen for Mild Cognitive Impairment; scores range from 0-22; with higher scores indicating better cognitive functioning. Scores 18 or below suggest cognitive dysfunction.
Measured: Phase I at 1 month
Cognition
Telephone Montreal Cognitive Assessment (T-MoCA) - measure assessing 8 areas of cognition used over the phone to screen for Mild Cognitive Impairment; scores range from 0-22; with higher scores indicating better cognitive functioning. Scores 18 or below suggest mild cognitive dysfunction.
Measured: Phase I at 3 months
Cognition
Telephone Montreal Cognitive Assessment (T-MoCA) - measure assessing 8 areas of cognition used over the phone to screen for Mild Cognitive Impairment; scores range from 0-22; with higher scores indicating better cognitive functioning. Scores 18 or below suggest mild cognitive dysfunction.
Measured: Phase II at screening
Cognition
Telephone Montreal Cognitive Assessment (T-MoCA) - measure assessing 8 areas of cognition used over the phone to screen for Mild Cognitive Impairment; scores range from 0-22; with higher scores indicating better cognitive functioning. Scores 18 or below suggest mild cognitive dysfunction.
Measured: Phase II at 3 months
Cognition
Telephone Montreal Cognitive Assessment (T-MoCA) - measure assessing 8 areas of cognition used over the phone to screen for Mild Cognitive Impairment; scores range from 0-22; with higher scores indicating better cognitive functioning. Scores 18 or below suggest mild cognitive dysfunction.
Measured: Phase II at 6 months
Functional Dependence - Activities of Daily Living (ADL)/Independent Activities of Daily Living (IADL)
Fifteen item scale created from Katz Activities of Daily Living- 6 item scale measuring ability to perform activities of daily living, 8 items from the Lawton Independent Activities of Daily Living scale assessing 8 domains of independent living skills (including shopping and taking medications) and 1 item on hygiene from the Routine Task Inventory; Scores range from 0-30 with higher scores needing more help with ADL/IADLs.
Measured: Phase I at baseline
Functional Dependence - Activities of Daily Living (ADL)/Independent Activities of Daily Living (IADL)
Fifteen item scale created from Katz Activities of Daily Living- 6 item scale measuring ability to perform activities of daily living, 8 items from the Lawton Independent Activities of Daily Living scale assessing 8 domains of independent living skills (including shopping and taking medications) and 1 item on hygiene from the Routine Task Inventory; Scores range from 0-30 with higher scores needing more help with ADL/IADLs.
Measured: Phase I at 1 month
Functional Dependence - Activities of Daily Living (ADL)/Independent Activities of Daily Living (IADL)
Fifteen item scale created from Katz Activities of Daily Living- 6 item scale measuring ability to perform activities of daily living, 8 items from the Lawton Independent Activities of Daily Living scale assessing 8 domains of independent living skills (including shopping and taking medications) and 1 item on hygiene from the Routine Task Inventory; Scores range from 0-30 with higher scores needing more help with ADL/IADLs.
Measured: Phase I at 3 months
Functional Dependence - Activities of Daily Living (ADL)/Independent Activities of Daily Living
Fifteen item scale created from Katz Activities of Daily Living- 6 item scale measuring ability to perform activities of daily living, 8 items from the Lawton Independent Activities of Daily Living scale assessing 8 domains of independent living skills (including shopping and taking medications) and 1 item on hygiene from the Routine Task Inventory; Scores range from 0-30 with higher scores needing more help with ADL/IADLs.
Measured: Phase II at baseline
Functional Dependence - Activities of Daily Living (ADL)/Independent Activities of Daily Living
Fifteen item scale created from Katz Activities of Daily Living- 6 item scale measuring ability to perform activities of daily living, 8 items from the Lawton Independent Activities of Daily Living scale assessing 8 domains of independent living skills (including shopping and taking medications) and 1 item on hygiene from the Routine Task Inventory; Scores range from 0-30 with higher scores needing more help with ADL/IADLs.
Measured: Phase II at 3 months
Functional Dependence - Activities of Daily Living (ADL)/Independent Activities of Daily Living (IADL)
Fifteen item scale created from Katz Activities of Daily Living- 6 item scale measuring ability to perform activities of daily living, 8 items from the Lawton Independent Activities of Daily Living scale assessing 8 domains of independent living skills (including shopping and taking medications) and 1 item on hygiene from the Routine Task Inventory; Scores range from 0-30 with higher scores needing more help with ADL/IADLs.
Measured: Phase II at 6 months
Functional Dependence (Physical functioning)
US Health Interview Survey - assesses engagement in physical activities in the prior two weeks. A composite index of physical activity is computed by summing the products of the number of minutes in each activity (9 are listed and there is an open response "other" option) and how many times in the past two weeks the engaged in the activity for the 9 activities and any open response activities, the total number of minutes during the past 2 weeks is divided by 60 minutes, and then by 2, to determine the number of hours of physical activity per week. The minimum composite index is 0. A higher composite index indicates more physical activity.
Measured: Phase I at baseline.
Functional Dependence (Physical functioning)
US Health Interview Survey - assesses engagement in physical activities in the prior two weeks. A composite index of physical activity is computed by summing the products of the number of minutes in each activity (9 are listed and there is an open response "other" option) and how many times in the past two weeks the engaged in the activity for the 9 activities and any open response activities, the total number of minutes during the past 2 weeks is divided by 60 minutes, and then by 2, to determine the number of hours of physical activity per week. The minimum composite index is 0. A higher composite index indicates more physical activity.
Measured: Phase I at 1 month
Functional Dependence (Physical functioning)
US Health Interview Survey - assesses engagement in physical activities in the prior two weeks. A composite index of physical activity is computed by summing the products of the number of minutes in each activity (9 are listed and there is an open response "other" option) and how many times in the past two weeks the engaged in the activity for the 9 activities and any open response activities, the total number of minutes during the past 2 weeks is divided by 60 minutes, and then by 2, to determine the number of hours of physical activity per week. The minimum composite index is 0. A higher composite index indicates more physical activity.
Measured: Phase I at 3 months
Functional Dependence (Physical functioning)
US Health Interview Survey - assesses engagement in physical activities in the prior two weeks. A composite index of physical activity is computed by summing the products of the number of minutes in each activity (9 are listed and there is an open response "other" option) and how many times in the past two weeks the engaged in the activity for the 9 activities and any open response activities, the total number of minutes during the past 2 weeks is divided by 60 minutes, and then by 2, to determine the number of hours of physical activity per week. The minimum composite index is 0. A higher composite index indicates more physical activity.
Measured: Phase II at baseline
Functional Dependence (Physical functioning)
US Health Interview Survey - assesses engagement in physical activities in the prior two weeks. A composite index of physical activity is computed by summing the products of the number of minutes in each activity (9 are listed and there is an open response "other" option) and how many times in the past two weeks the engaged in the activity for the 9 activities and any open response activities, the total number of minutes during the past 2 weeks is divided by 60 minutes, and then by 2, to determine the number of hours of physical activity per week. The minimum composite index is 0. A higher composite index indicates more physical activity.
Measured: Phase II at 3 months
Functional Dependence (Physical functioning)
US Health Interview Survey - assesses engagement in physical activities in the prior two weeks. A composite index of physical activity is computed by summing the products of the number of minutes in each activity (9 are listed and there is an open response "other" option) and how many times in the past two weeks the engaged in the activity for the 9 activities and any open response activities, the total number of minutes during the past 2 weeks is divided by 60 minutes, and then by 2, to determine the number of hours of physical activity per week. The minimum composite index is 0. A higher composite index indicates more physical activity.
Measured: Phase II at 6 months
Behavioral Activation Scale
8 items based on Kanter et al., 2007 behavioral activation for depression scale. 1 item developed and added per researcher discretion. Responses range from 0 (meaning not at all) to 6 (meaning completely). Two items are reverse coded. Scores at each time point will be averaged.
Measured: Phase I at baseline.
Behavioral Activation Scale
8 items based on Kanter et al., 2007 behavioral activation for depression scale. 1 item developed and added per researcher discretion. Responses range from 0 (meaning not at all) to 6 (meaning completely). Two items are reverse coded. Scores at each time point will be averaged.
Measured: Phase I at 1 month.
Behavioral Activation Scale
8 items based on Kanter et al., 2007 behavioral activation for depression scale. 1 item developed and added per researcher discretion. Responses range from 0 (meaning not at all) to 6 (meaning completely). Two items are reverse coded. Scores at each time point will be averaged.
Measured: Phase I at 3 months.
Behavioral Activation Scale
8 items based on Kanter et al., 2007 behavioral activation for depression scale. 1 item developed and added per researcher discretion. Responses range from 0 (meaning not at all) to 6 (meaning completely). Two items are reverse coded. Scores at each time point will be averaged.
Measured: Phase II at baseline.
Behavioral Activation Scale
8 items based on Kanter et al., 2007 behavioral activation for depression scale. 1 item developed and added per researcher discretion. Responses range from 0 (meaning not at all) to 6 (meaning completely). Two items are reverse coded. Scores at each time point will be averaged.
Measured: Phase II at 3 months.
Behavioral Activation Scale
8 items based on Kanter et al., 2007 behavioral activation for depression scale. 1 item developed and added per researcher discretion. Responses range from 0 (meaning not at all) to 6 (meaning completely). Two items are reverse coded. Scores at each time point will be averaged.
Measured: Phase II at 6 months.
Utilization of Unpaid Social Support Care Resources
10-item yes or no checklist developed based on Kasper et al., 2015. 1 additional open-ended item is added to ask about other forms of unpaid social support. The total number of yes responses for each participant will be summed at each time point.
Measured: Phase I at baseline.
Utilization of Unpaid Social Support Care Resources
10-item yes or no checklist developed based on Kasper et al., 2015. 1 additional open-ended item is added to ask about other forms of unpaid social support. The total number of yes responses for each participant will be summed at each time point.
Measured: Phase I at one month.
Utilization of Unpaid Social Support Care Resources
10-item yes or no checklist developed based on Kasper et al., 2015. 1 additional open-ended item is added to ask about other forms of unpaid social support. The total number of yes responses for each participant will be summed at each time point.
Measured: Phase I at three months.
Utilization of Unpaid Social Support Care Resources
10-item yes or no checklist developed based on Kasper et al., 2015. 1 additional open-ended item is added to ask about other forms of unpaid social support. The total number of yes responses for each participant will be summed at each time point.
Measured: Phase II at baseline.
Utilization of Unpaid Social Support Care Resources
10-item yes or no checklist developed based on Kasper et al., 2015. 1 additional open-ended item is added to ask about other forms of unpaid social support. The total number of yes responses for each participant will be summed at each time point.
Measured: Phase II at 3 months.
Utilization of Unpaid Social Support Care Resources
10-item yes or no checklist developed based on Kasper et al., 2015. 1 additional open-ended item is added to ask about other forms of unpaid social support. The total number of yes responses for each participant will be summed at each time point.
Measured: Phase II at 6 months.
Paid Service Use
12-item measure assessing the utilization of paid community-based, residential, or other services. Response options include "I use this service," "I would like to use this service," and "I don't need to use this service." The number of services used will be summed at each time point for each participant.
Measured: Phase I at baseline.
Paid Service Use
12-item measure assessing the utilization of paid community-based, residential, or other services. Response options include "I use this service," "I would like to use this service," and "I don't need to use this service." The number of services used will be summed at each time point for each participant.
Measured: Phase I at one month.
Paid Service Use
12-item measure assessing the utilization of paid community-based, residential, or other services. Response options include "I use this service," "I would like to use this service," and "I don't need to use this service." The number of services used will be summed at each time point for each participant.
Measured: Phase I at three months.
Paid Service Use
12-item measure assessing the utilization of paid community-based, residential, or other services. Response options include "I use this service," "I would like to use this service," and "I don't need to use this service." The number of services used will be summed at each time point for each participant.
Measured: Phase II at baseline.
Paid Service Use
12-item measure assessing the utilization of paid community-based, residential, or other services. Response options include "I use this service," "I would like to use this service," and "I don't need to use this service." The number of services used will be summed at each time point for each participant.
Measured: Phase II at 3 months.
Paid Service Use
12-item measure assessing the utilization of paid community-based, residential, or other services. Response options include "I use this service," "I would like to use this service," and "I don't need to use this service." The number of services used will be summed at each time point for each participant.
Measured: Phase II at 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2023
- Study start15 Apr 2023
- Primary completion29 Jul 2025
- Study completion29 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joseph Gaugler, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05746390
- Sponsor's protocol ID
- STUDY00017313
- Status last verified
- Sep 2025
- First submitted
- 10 Feb 2023
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study data and appropriate study materials/documentation will be deposited and made available through the National Archive of Computerized Data on Aging (NACDA), a NIA/NIH funded repository.
Publications
Birkeland RW, Ingvalson SN, Savard GM, Hobday A, Urbanski D, Pepin R, Gitlin LN, Cigliana J, Gaugler JE. Evaluating the Feasibility, Acceptability, and Utility of the Home Alone Intervention: A Mixed Methods Pilot Study. J Aging Res. 2026 May 19;2026:4036735. doi: 10.1155/jare/4036735. eCollection 2026.
PubMed 42164748
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home Alone: Developing a Home-Based Intervention for People With Cognitive Impairment Who Live Alone
- ClinicalTrials.gov ID
- NCT05746390
- Acronym / sponsor ID
- STUDY00017313
- Conditions
- Cognitive Impairment, Dementia, Memory Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 15 Apr 2023 (actual)
- Primary completion
- 29 Jul 2025 (actual)
- Study completion
- 29 Jul 2025 (actual)
- First posted
- 27 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to evaluate a program for adults who live alone and have some cognitive impairment (CI) to see if it is useful and acceptable. This program aims to help older adults with cognitive impairment who live alone to be engaged and active, as well as safe at home. The investigators want to see how useful this program is and how it can be improved.
The specific aims are:
- Specific Aim 1: Develop and Adapt Home Alone to Prepare for Pilot Testing.
- Specific Aim 2: Pilot Test a Revised Version of Home Alone.
Phase I participants will be asked to:
- Participate for 3 months
- Complete 3 surveys
- Complete 7 1-hour meetings on a weekly basis with a coach
- Complete a final interview
Phase II participants will be asked to:
- Participate for 6 months
- Complete 3 surveys
- Complete 7 1-hour meetings on a weekly basis with a coach
- A sub-sample will be asked to complete a final interview
Detailed description
The primary goal of this proposal is to establish the feasibility, acceptability, and appropriateness of a novel intervention, "Home Alone." Home Alone will be targeted to older persons with CI or Mild Cognitive Impairment (MCI) who live alone in the community. This National Institute on Aging (NIA) Stage I effort will adapt and tailor established, evidence-based mental health and dementia care intervention models (behavioral activation, Skills2Care®, Tailored Activity Program) to reduce environmental stress and enhance engagement in desired activities to improve social well-being and maintain cognition and function for those who live alone with CI. Relying on a robust, mixed methods strategy and an implementation science lens at the outset of intervention development, the investigators seek to position Home Alone as a scalable program that, as its efficacy and effectiveness is determined in subsequent trials, is primed for widespread dissemination and adoption in home-based and community contexts.
The Specific Aims are as follows:
Specific Aim 1 (Phase I): Develop and Adapt Home Alone to Prepare for Pilot Testing. The investigators will identify treatment components and examine feasibility and relevance by obtaining insights from 15 persons with CI who live alone and participate in the Home Alone intervention over a 3-month period. The investigators will utilize the Phase I period to determine whether various elements of Home Alone (e.g., delivery mode, length, and other intervention characteristics) require adaptation. The investigators will use a convergent parallel mixed methods design (i.e., the collection and analysis of quantitative and qualitative data concurrently) when doing so. Through analysis of the various quantitative and qualitative data elements to inform adaptation, the investigators will finalize and refine Home Alone prior to project Phase II (Specific Aim 2).
Specific Aim 2 (Phase II): Pilot Test a Revised Version of Home Alone. This R21 project will evaluate the following indices of implementation potential over a 6-month period: whether Home Alone is carried out as intended and is feasible (the degree to which Home Alone can be successfully delivered); acceptable (Home Alone is agreeable and satisfactory among users), and useful (participants perceive benefit from the Home Alone intervention). A sequential explanatory mixed methods design (a quantitative component followed by a qualitative component) will be utilized to pilot test Home Alone. The investigators will enroll 50 persons living alone with CI over a 6-month period. The investigators will also examine whether key empirical outcomes (perceived loneliness; activity engagement; measures of cognition and functional dependence) change over a 6-month period. Available qualitative data will provide information on how and why Home Alone was beneficial or not for persons with CI and allow for greater understanding of the intervention's mechanisms of benefit.
Home Alone combines Behavioral Activation (BA) with other evidence-based intervention approaches (i.e., Tailored Activity Program (TAP); Skills2Care®) that target the environment in order to tailor activity that is fulfilling and meaningful to persons with CI. An additional intervention component that will be incorporated in Home Alone includes environmental assessments that help the person with CI by removing objects and improving lighting and safety in areas of the home where a desired and meaningful activity will be conducted.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Home Alone Intervention | Experimental | Behavioral: Home AloneHome Alone is a semi-structured intervention, tailored to address the individual needs and concerns of the older adult. The participant will engage in about seven psychoeducational coaching sessions, each lasting approximately one hour. The intervention has two key foci: 1. increasing or maintaining home safety and comfort 2. increasing scheduled social engagements and activities. Sessions are also designed to identify formal and informal services and supports to improve to increase assistance and ability to live independently for as long as safely possible. The sessions take place either in-person or remotely (via secure video conferencing or telephone). Ad hoc/ongoing sessions may be provided as needed. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 55 years of age or older
- Lives alone in a non-residential setting
- Either 1) provider diagnosis of MCI, 2) Montreal Cognitive Assessment by telephone (T-MoCA) score between 13 and 18, and/or 3) subjective endorsement of memory impairment on screening
- Resides in the US
- Demonstrates capacity to consent
Key exclusion criteria (7 listed)
- Those who do not meet the inclusion criteria above are not eligible. Additionally, researchers would exclude those who:
- Live in assisted living, a group care home, or similar residential setting that provides care and services
- Are not English speaking
- Are currently participating in any other type of service that provides one-to-one psychosocial consultation or independent living coaching
- Have a new or worsening mental health condition and are not receiving ongoing treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home AloneSee Home Alone description. | Behavioural | Home Alone Intervention |
Primary outcome
Acceptability of Intervention
Time frame: Phase I at 1 month
Acceptability of Intervention Measure - 4 item scale evaluating program acceptability. The measure evaluates the likeability of the intervention (e.g. I like the intervention; I welcome the intervention; the intervention meets my approval; the intervention is appealing to me). Items are rated on a scale of agreement (completely disagree, disagree, neither agree or disagree, agree, completely agree). Scores range from 4-20, with higher scores indicating higher levels of acceptability.
Acceptability of Intervention
Time frame: Phase I at 3 months
Acceptability of Intervention Measure - 4 item scale evaluating program acceptability. The measure evaluates the likeability of the intervention (e.g. I like the intervention; I welcome the intervention; the intervention meets my approval; the intervention is appealing to me). Items are rated on a scale of agreement (completely disagree, disagree, neither agree or disagree, agree, completely agree). Scores range from 4-20, with higher scores indicating higher levels of acceptability.
Acceptability of Intervention
Time frame: Phase II at 3 months
Acceptability of Intervention Measure - 4 item scale evaluating program acceptability. The measure evaluates the likeability of the intervention (e.g. I like the intervention; I welcome the intervention; the intervention meets my approval; the intervention is appealing to me). Items are rated on a scale of agreement (completely disagree, disagree, neither agree or disagree, agree, completely agree). Scores range from 4-20, with higher scores indicating higher levels of acceptability.
Acceptability of Intervention
Time frame: Phase II at 6 months
Acceptability of Intervention Measure - 4 item scale evaluating program acceptability. The measure evaluates the likeability of the intervention (e.g. I like the intervention; I welcome the intervention; the intervention meets my approval; the intervention is appealing to me). Items are rated on a scale of agreement (completely disagree, disagree, neither agree or disagree, agree, completely agree). Scores range from 4-20, with higher scores indicating higher levels of acceptability.
Feasibility of Intervention
Time frame: Phase I at 1 month
Feasibility of Intervention Measure - 4 item scale evaluating program feasibility; The measure includes four statements about the feasibility of intervention implementation (ex. the intervention seems implementable; the intervention seems doable; the intervention seems possible; the intervention seems easy to use). Items are rated on a five-point scale (completely disagree, disagree, neither agree or disagree, agree, completely agree). Scores range from 4-20. Higher scores indicate greater feasibility.
Feasibility of Intervention
Time frame: Phase I at 3 months
Feasibility of Intervention Measure - 4 item scale evaluating program feasibility; The measure includes four statements about the feasibility of intervention implementation (ex. the intervention seems implementable; the intervention seems doable; the intervention seems possible; the intervention seems easy to use). Items are rated on a five-point scale (completely disagree, disagree, neither agree or disagree, agree, completely agree). Scores range from 4-20. Higher scores indicate greater feasibility.
Feasibility of Intervention
Time frame: Phase II at 3 months
Feasibility of Intervention Measure - 4 item scale evaluating program feasibility; The measure includes four statements about the feasibility of intervention implementation (ex. the intervention seems implementable; the intervention seems doable; the intervention seems possible; the intervention seems easy to use). Items are rated on a five-point scale (completely disagree, disagree, neither agree or disagree, agree, completely agree). Scores range from 4-20. Higher scores indicate greater feasibility.
Feasibility of Intervention
Time frame: Phase II at 6 months
Feasibility of Intervention Measure - 4 item scale evaluating program feasibility; The measure includes four statements about the feasibility of intervention implementation (ex. the intervention seems implementable; the intervention seems doable; the intervention seems possible; the intervention seems easy to use). Items are rated on a five-point scale (completely disagree, disagree, neither agree or disagree, agree, completely agree). Scores range from 4-20. Higher scores indicate greater feasibility.
Intervention Appropriateness
Time frame: Phase I at 1 month
Intervention Appropriateness Measure - 4 item scale evaluating program appropriateness; The measure includes four statements about the feasibility of intervention implementation (ex. the intervention seems fitting; the intervention seems suitable; the intervention seems applicable; the intervention seems liked a good match). Items are rated on a five-point scale (completely disagree, disagree, neither agree or disagree, agree, completely agree). Scores range from 4-20. Higher scores indicate greater appropriateness.
Intervention Appropriateness
Time frame: Phase I at 3 months
Intervention Appropriateness Measure - 4 item scale evaluating program appropriateness; The measure includes four statements about the feasibility of intervention implementation (ex. the intervention seems fitting; the intervention seems suitable; the intervention seems applicable; the intervention seems liked a good match). Items are rated on a five-point scale (completely disagree, disagree, neither agree or disagree, agree, completely agree). Scores range from 4-20. Higher scores indicate greater appropriateness.
Intervention Appropriateness
Time frame: Phase II at 3 months
Intervention Appropriateness Measure - 4 item scale evaluating program appropriateness; The measure includes four statements about the feasibility of intervention implementation (ex. the intervention seems fitting; the intervention seems suitable; the intervention seems applicable; the intervention seems liked a good match). Items are rated on a five-point scale (completely disagree, disagree, neither agree or disagree, agree, completely agree). Scores range from 4-20. Higher scores indicate greater appropriateness.
Intervention Appropriateness
Time frame: Phase II at 6 months
Intervention Appropriateness Measure - 4 item scale evaluating program appropriateness; The measure includes four statements about the feasibility of intervention implementation (ex. the intervention seems fitting; the intervention seems suitable; the intervention seems applicable; the intervention seems liked a good match). Items are rated on a five-point scale (completely disagree, disagree, neither agree or disagree, agree, completely agree). Scores range from 4-20. Higher scores indicate greater appropriateness.
Intervention Treatment Receipt
Time frame: Phase I at 1 month
Intervention Treatment Receipt Checklist Measure - Eleven item checklist designed for study, measuring whether the coach delivered key aspects of the intervention. The measure includes 10 Likert scale items and one open-ended question on the appropriateness and acceptability of Home Alone and the extent to which Home Alone helps participants with CI modify their environment, engage in pleasant activities, and access social and other resources. The 10 items are scored on a 5 point Likert scale with a total score ranging from 0-50, where higher scores indicate greater treatment fidelity and acceptability of the intervention.
Intervention Treatment Receipt
Time frame: Phase I at 3 months
Intervention Treatment Receipt Checklist Measure - Eleven item checklist designed for study, measuring whether the coach delivered key aspects of the intervention. The measure includes 10 Likert scale items and one open-ended question on the appropriateness and acceptability of Home Alone and the extent to which Home Alone helps participants with CI modify their environment, engage in pleasant activities, and access social and other resources. The 10 items are scored on a 5 point Likert scale with a total score ranging from 0-50, where higher scores indicate greater treatment fidelity and acceptability of the intervention.
Intervention Treatment Receipt
Time frame: Phase II at 3 months
Intervention Treatment Receipt Checklist Measure - Eleven item checklist designed for study, measuring whether the coach delivered key aspects of the intervention. The measure includes 10 Likert scale items and one open-ended question on the appropriateness and acceptability of Home Alone and the extent to which Home Alone helps participants with CI modify their environment, engage in pleasant activities, and access social and other resources. The 10 items are scored on a 5 point Likert scale with a total score ranging from 0-50, where higher scores indicate greater treatment fidelity and acceptability of the intervention.
Intervention Treatment Receipt
Time frame: Phase II at 6 months
Intervention Treatment Receipt Checklist Measure - Eleven item checklist designed for study, measuring whether the coach delivered key aspects of the intervention. The measure includes 10 Likert scale items and one open-ended question on the appropriateness and acceptability of Home Alone and the extent to which Home Alone helps participants with CI modify their environment, engage in pleasant activities, and access social and other resources. The 10 items are scored on a 5 point Likert scale with a total score ranging from 0-50, where higher scores indicate greater treatment fidelity and acceptability of the intervention.
60 secondary outcomes
Social Well-being/Loneliness (Social contact and Support)
Time frame: Phase I at baseline
Social Well-being/Loneliness (Social contact and Support)
Time frame: Phase I at 1 month
Social Well-being/Loneliness (Social contact and Support)
Time frame: Phase I at 3 months
Social Well-being/Loneliness (Social contact and Support)
Time frame: Phase II at baseline
Social Well-being/Loneliness (Social contact and Support)
Time frame: Phase II at 3 months
Social Well-being/Loneliness (Social contact and Support)
Time frame: Phase II at 6 months
Social Well-being/Loneliness (Loneliness)
Time frame: Phase I at baseline
Social Well-being/Loneliness (Loneliness)
Time frame: Phase I at 1 month
Social Well-being/Loneliness (Loneliness)
Time frame: Phase I at 3 months
Social Well-being/Loneliness (Loneliness)
Time frame: Phase II at baseline
Social Well-being/Loneliness (Loneliness)
Time frame: Phase II at 3 months
Social Well-being/Loneliness (Loneliness)
Time frame: Phase II at 6 months
Social Well-being/Loneliness (Well-being)
Time frame: Phase I at baseline
Social Well-being/Loneliness (Well-being)
Time frame: Phase I at 1 month
Social Well-being/Loneliness (Well-being)
Time frame: Phase I at 3 months
Social Well-being/Loneliness (Well-being)
Time frame: Phase II at baseline
Social Well-being/Loneliness (Well-being)
Time frame: Phase II at 3 months
Social Well-being/Loneliness (Well-being)
Time frame: Phase II at 6 months
Activity/Engagement
Time frame: Phase I at baseline
Activity/Engagement
Time frame: Phase I at 1 month
Activity/Engagement
Time frame: Phase I at 3 months
Activity/Engagement
Time frame: Phase II at baseline
Activity/Engagement
Time frame: Phase II at 3 months
Activity/Engagement
Time frame: Phase II at 6 months
Cognition
Time frame: Phase I at screening
Cognition
Time frame: Phase I at 1 month
Cognition
Time frame: Phase I at 3 months
Cognition
Time frame: Phase II at screening
Cognition
Time frame: Phase II at 3 months
Cognition
Time frame: Phase II at 6 months
Functional Dependence - Activities of Daily Living (ADL)/Independent Activities of Daily Living (IADL)
Time frame: Phase I at baseline
Functional Dependence - Activities of Daily Living (ADL)/Independent Activities of Daily Living (IADL)
Time frame: Phase I at 1 month
Functional Dependence - Activities of Daily Living (ADL)/Independent Activities of Daily Living (IADL)
Time frame: Phase I at 3 months
Functional Dependence - Activities of Daily Living (ADL)/Independent Activities of Daily Living
Time frame: Phase II at baseline
Functional Dependence - Activities of Daily Living (ADL)/Independent Activities of Daily Living
Time frame: Phase II at 3 months
Functional Dependence - Activities of Daily Living (ADL)/Independent Activities of Daily Living (IADL)
Time frame: Phase II at 6 months
Functional Dependence (Physical functioning)
Time frame: Phase I at baseline.
Functional Dependence (Physical functioning)
Time frame: Phase I at 1 month
Functional Dependence (Physical functioning)
Time frame: Phase I at 3 months
Functional Dependence (Physical functioning)
Time frame: Phase II at baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
- Derived from this study: PubMed 42164748Birkeland RW, Ingvalson SN, Savard GM, Hobday A, Urbanski D, Pepin R, Gitlin LN, Cigliana J, Gaugler JE. Evaluating the Feasibility, Acceptability, and Utility of the Home Alone Intervention: A Mixed Methods Pilot Study. J Aging Res. 2026 May 19;2026:4036735. doi: 10.1155/jare/4036735. eCollection 2026.
- Individual participant dataSharing planned: Yes. Study data and appropriate study materials/documentation will be deposited and made available through the National Archive of Computerized Data on Aging (NACDA), a NIA/NIH funded repository.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph Gaugler, PhD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home Alone in people with Cognitive Impairment and Dementia, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of Intervention (time frame: Phase I at 1 month). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05746390, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2025.