DementiaNCT05916664
Efficacy Study of Kinto Care Coaching for Dementia Family Caregivers
A study testing Kinto Care Coaching in people with Dementia and Alzheimer Disease, run by Kinto at 1 site in United States.
Trial summary
The goal of this clinical trial is to evaluate Kinto's Care Coaching intervention for dementia caregivers. The main questions it aims to answer are: Does the intervention help caregivers to address their general caregiving goals Does the intervention help caregivers to address their financial caregiving goals… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dementia, Alzheimer Disease, Lewy Body Disease
- What is being tested?
- Kinto Care Coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 495 participants
- Where
- 1 siteUnited States
- Study dates
- 18 May 2023to 22 Apr 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants must be:
- 18 years or older
- Caring for a family member or close friend with dementia or memory loss
- Providing 5 or more hours of care or support each week
- Not getting paid for the care/support
- Fluent in English, or both Spanish and English
Show all 9Show fewer
- Living in the United States
- They must:
- ● Have access to a smart phone, reliable internet service and an email address
Who cannot join
- Participants can not:
- Currently be participating in another non-pharmacological intervention
- Have participated in a previous Kinto study
Trial locations and contacts
1 site in 1 country.
United States1 site
Alzheimer's Association Head Office
Chicago, Illinois, 60603
About this study
Official title: Phase II Efficacy Study of a Technology-enabled Care Coaching Service for Families Caring for AD/ADRD
The goal of this clinical trial is to evaluate Kinto's Care Coaching intervention for dementia caregivers.
The main questions it aims to answer are:
Read more
Does the intervention help caregivers to address their general caregiving goals Does the intervention help caregivers to address their financial caregiving goals
Participants will have access to:
One-on-one care coaching sessions (via zoom) Up to 6 weekly support groups with other caregivers A variety of digital resources through Kinto's mobile app
Researchers will compare intervention and control groups to see if the program supports caregivers' general and financial caregiving needs.
The efficacy of the intervention also will be examined on key outcomes.
Read the detailed description
The study will include 300 family caregivers drawn from throughout the US, who will engage remotely with the coaches (and one another) using zoom and Kinto's mobile caregiver app.
Caregivers will be randomly assigned to one of two groups to evaluate the impact of the program by making a comparison of those caregivers who received the program (Group
- and those caregivers who will not receive the program (Group 2). Caregivers assigned to Group 2, the control condition, will be eligible to receive a modified version of the program after completion of the study and data collection protocols.
The intervention is a care coaching program that assists caregivers with their general caregiving goals and financial caregiving goals. Caregivers will attend a one-on-one care coaching session conducted via Zoom for 60-75 minutes with a care coach and will engage with their care coach through chat-based interactions after completing the session. If requested, up to two additional care coaching sessions will be scheduled.
Caregivers also will have the opportunity to attend up to 6 weekly support groups with other caregivers facilitated by a care coach and receive a variety of digital resources through the mobile app.
As guided by the NIH Stage Model for Behavioral Intervention Development, the primary goal of the Phase 2 study is to examine the efficacy of the program on select outcomes for caregivers (i.e., Stage III Real-World Efficacy). As such, the selected data collection periods of T1 (prior to the intervention), T2 (immediately following the initial six week intervention period) and T3 (45 days following this date) will evaluate the immediate and short-term efficacy of the program.
Recruiting of caregivers is scheduled to begin in May 2023. The study plan targets recruitment of three cohorts, each with one hundred participants. The first intervention group will begin the program in August 2023. Subsequent cohorts will begin the study at 8-9 week intervals. The plan includes a contingency to run two additional cohorts (to mitigate any recruitment or retention risk). In the event that all five cohorts are used to achieve participation goals, the final cohort is scheduled to complete the intervention and survey requirements no later than August of 2024.
- Conditions
- Dementia, Alzheimer Disease, Lewy Body Disease, Vascular Dementia, Frontotemporal Dementia, Mixed Dementia
- Being tested
- Kinto Care Coaching
- Keywords
- Caregiving, Financial Education, Technology, Behavioral Intervention, Caregiver Support Intervention, Financial Literacy, Financial Preparedness, Caregiver Well Being, Caregiver Stress, Caregiver Burden
- Medical subject headings
- Dementia, Alzheimer Disease, Lewy Body Disease, Dementia, Vascular, Frontotemporal Dementia, Mixed Dementias, Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kinto Care CoachingBehavioural
Describe the basics of the intervention
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The intervention is a care coaching program that assists caregivers with their general caregiving goals and financial caregiving goals. Caregivers will attend a one-on-one care coaching session conducted via Zoom for 60-75 minutes with a care coach and will engage with their care coach through chat-based interactions after completing the session. If requested, up to two additional care coaching sessions will be scheduled.
Caregivers also will have the opportunity to attend up to 6 weekly support groups with other caregivers facilitated by a care coach and receive a variety of digital resources through the mobile app. Receives: Behavioral: Kinto Care Coaching |
| Control | No intervention | Control group that does not receive the Caregiver Support Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caregiver Mastery
Caregiver Mastery is a 9-item self-report questionnaire that assesses how competent individuals feel in their role as caregivers of individuals with dementia. Example items include I became more self-confident in providing care and I felt I was pretty good at figuring out what he/she needed. The measure is scored using a 4-point Likert scale (1=strongly disagree to 4=strongly agree) with higher scores indicating greater caregiver mastery. The total score (reported in this study) is calculated as the average of the item scores, and ranges from 1 to 4, with higher scores indicating greater caregiver mastery.
Measured: Changes in caregiver mastery between the control and intervention conditions will be evaluated across time from T1 (baseline) to T2 (post-intervention completion/6-weeks from baseline) and T3 (45 days from T2).
Emotional Health Strain
Emotional Health Strain is a 4-item self-report questionnaire that assesses how emotionally strained individuals feel in their role as caregivers of individuals with dementia. Example items include I was under more stress, strain, or pressure and I was more nervous or bothered by nerves than before. The measure is scored using a 4-point Likert scale (1=strongly disagree to 4=strongly agree) with higher scores indicating more emotional health strain. The total score (reported in this study) is calculated as the average of the item scores, and ranges from 1 to 4, with higher scores indicating greater emotional health strain.
Measured: Changes in emotional health strain between the control and intervention conditions will be evaluated across time from T1 (baseline) to T2 (post-intervention completion/6-weeks from baseline) and T3 (45 days from T2).
Personal Gain
Personal Gain is a 4-item self-report questionnaire that assesses the personal gain experienced by individuals in their role as caregivers of individuals with dementia. Example items include Become more aware of your inner strengths and Become more self-confident. The measure is scored using a 4-point Likert scale (1=not at all to 4=a great deal) with higher scores indicating greater personal gain. The total score (reported in this study) is calculated as the average of the item scores, and ranges from 1 to 4, with higher scores indicating greater personal gain.
Measured: Changes in personal gain between the control and intervention conditions will be evaluated across time from T1 (baseline) to T2 (post-intervention completion/6-weeks from baseline) and T3 (45 days from T2).
Financial Self-Efficacy
Financial Self-Efficacy is a 10-item self-report questionnaire that assesses how efficacious individuals feel in their financial preparedness and skills for managing money as related to their caregiving role. Example items include I am confident that I will be able to successfully manage my loved one's finances and I feel confident in talking with my loved one about their finances. The measure is scored using a 4-point Likert scale (1=not at all to 4=a great deal) with higher scores indicating greater financial self-efficacy. The total score (reported in this study) is calculated as the average of the item scores, and ranges from 1 to 4, with higher scores indicating greater financial self-efficacy.
Measured: Changes in financial self-efficacy between the control and intervention conditions will be evaluated across time from T1 (baseline) to T2 (post-intervention completion/6-weeks from baseline) and T3 (45 days from T2).
ULS-8 Loneliness Scale
The ULS-8 Loneliness Scale is an 11 item self-report questionnaire that assesses how lonely individuals feel with 8 original items and 3 additional items. Example items include I feel very close to one or more people and There are people who really understand me. The measure is scored using a 4-point Likert scale (1=strongly disagree to 4=strongly agree) with lower scores indicating greater feelings of loneliness. The total score (reported in this study) is calculated as the average of the item scores, and ranges from 1 to 4, with lower scores indicating greater feelings of loneliness.
Measured: Changes in loneliness between the control and intervention conditions will be evaluated across time from T1 (baseline) to T2 (post-intervention completion/6-weeks from baseline) and T3 (45 days from T2).
Perceived Financial Knowledge
Perceived Financial Knowledge is a 1-item self-report questionnaire that assesses an individual's perceived knowledge about their financial preparedness and skills for managing money as related to their caregiving role. The item states Please rate your current understanding of how to manage money for you or the person you are caring for. The measure is scored using a 5-point Likert scale (1=no knowledge to 5=expert knowledge) with higher scores indicating greater perceived financial knowledge.
Measured: Changes in perceived financial knowledge between the control and intervention conditions will be evaluated across time from T1 (baseline) to T2 (post-intervention completion/6-weeks from baseline) and T3 (45 days from T2).
Caregiver Burden
Caregiver Burden is a 4-item self-report questionnaire that assesses how much strain and stress individuals feel in their caregiving role for individuals with dementia. Example items include Do you feel that because of the time you spend with your relative that you don't have enough time for yourself and Do you feel stressed between caring for your relative and trying to meet other responsibilities (work/family)? The measure is scored using a 5-point Likert scale (1=never to 5=nearly always) with higher scores indicating greater caregiver burden. The total score (reported in this study) is calculated as the average of the item scores, and ranges from 1 to 5, with higher scores indicating greater caregiver burden.
Measured: Changes in caregiver burden between the control and intervention conditions will be evaluated across time from T1 (baseline) to T2 (post-intervention completion/6-weeks from baseline) and T3 (45 days from T2).
Secondary outcomes (12)
Dyadic Relationship Strain
Dyadic Relationship Strain is a 7-item self-report questionnaire that assesses how strained individuals feel because of their caregiving relationship. Example items include I felt my relationship with him/her was strained and I felt resentful toward him/her. The measure is scored using a 4-point Likert scale (1=strongly disagree to 4=strongly agree) with higher scores indicating greater relationship strain. The total score (reported in this study) is calculated as the average of the item scores, and ranges from 1 to 4, with higher scores indicating greater relationship strain.
Measured: Changes in relationship strain between the control and intervention conditions will be evaluated across time from T1 (baseline) to T2 (post-intervention completion/6-weeks from baseline) and T3 (45 days from T2).
Role Captivity
Role Captivity is a 3-item self-report questionnaire that assesses the extent to which individuals feel trapped in their role as a caregiver. Example items include I wished I were free to lead my own life and I felt trapped having to care for him/her. The measure is scored using a 4-point Likert scale (1=strongly disagree to 4=strongly agree) with higher scores indicating greater role captivity. The total score (reported in this study) is calculated as the average of the item scores, and ranges from 1 to 4, with higher scores indicating greater role captivity.
Measured: Changes in role captivity between the control and intervention conditions will be evaluated across time from T1 (baseline) to T2 (post-intervention completion/6-weeks from baseline) and T3 (45 days from T2).
Caregiver Unmet Needs
Caregiver Unmet Needs is a 20-item self-report questionnaire that assesses unmet needs of caregivers. Example items include Do you need more information or help with understanding basic information about dementia? and Ideas to assist with your personal wellbeing as a caregiver? The measure is scored using dichotomous yes/no scoring (1=no/2=yes) with higher scores indicating more unmet needs. The total score (reported in this study) is calculated as the average of the item scores, and ranges from 1 to 2, with higher scores indicating more unmet needs.
Measured: Changes in unmet needs between the control and intervention conditions will be evaluated across time from T1 (baseline) to T2 (post-intervention completion/6-weeks from baseline) and T3 (45 days from T2).
Caregiver Unmet Needs Distress
Caregiver Unmet Needs Distress is a 20-item self-report questionnaire that assesses the resulting distress due to caregiver unmet needs. Example items include How distressing or upsetting is understanding basic information about dementia? and Ideas to assist with your personal wellbeing as a caregiver? The measure is scored using a 4-point Likert scale (1=not distressing to 4=very distressing) with higher scores indicating greater distress due to caregiver unmet needs. The total score (reported in this study) is calculated as the average of the item scores, and ranges from 1 to 4, with higher scores indicating greater distress due to caregiver unmet needs.
Measured: Changes in unmet needs distress between the control and intervention conditions will be evaluated across time from T1 (baseline) to T2 (post-intervention completion/6-weeks from baseline) and T3 (45 days from T2).
Anxiety
Anxiety is a 7-item self-report questionnaire that assesses symptoms of anxiety. Example items include Feel nervous, anxious or on edge and Feel that you could not stop or control worrying? The measure is scored using a 4-point Likert scale (1=not at all to 4=nearly every day) with higher scores indicating more symptoms of anxiety. The total score (reported in this study) is calculated as the average of the item scores, and ranges from 1 to 4, with higher scores indicating more symptoms of anxiety.
Measured: Changes in anxiety symptoms between the control and intervention conditions will be evaluated across time from T1 (baseline) to T2 (post-intervention completion/6-weeks from baseline) and T3 (45 days from T2).
Depression
Depression is an 11-item self-report questionnaire that assesses symptoms of depression. Example items include Feel depressed and Feel that everything you did was an effort? The measure is scored using a 3-point Likert scale (1=hardly ever to 3=often) with higher scores indicating more symptoms of depression. The total score (reported in this study) is calculated as the average of the item scores, and ranges from 1 to 3, with higher scores indicating more symptoms of depression.
Measured: Changes in depressive symptoms between the control and intervention conditions will be evaluated across time from T1 (baseline) to T2 (post-intervention completion/6-weeks from baseline) and T3 (45 days from T2).
Instrumental and Personal Activities of Daily Living - Difficulty
Instrumental and Personal Activities of Daily Living - Difficulty is a 16-item self-report questionnaire that assesses how much difficulty individuals with dementia experience in completing daily tasks as reported by their caregivers. Example items include How difficult was writing checks, paying bills, or balancing a checkbook? and Preparing a balanced meal? The measure is scored using a 4-point Likert scale (1=not difficult to 4=very difficult) with higher scores indicating more difficulty in completing instrumental activities. The total score (reported in this study) is calculated as the average of the item scores, and ranges from 1 to 4, with higher scores indicating more difficulty in completing instrumental activities.
Measured: Changes in instrumental activities of daily living difficulty between the control and intervention conditions will be evaluated across time from T1 (baseline) to T2 (post-intervention completion/6-weeks from baseline) and T3 (45 days from T2).
Instrumental and Personal Activities of Daily Living - Distress
Instrumental Activities of Daily Living - Distress is a 16-item self-report questionnaire that assesses the resulting distress caregivers experience due to the amount of instrumental activities of daily living difficulty experienced by the individual they care for. Example items include How distressing or upsetting was this for you when the person you care performed these activities: Writing checks, paying bills, or balancing a checkbook? and Preparing a balanced meal? The measure is scored using a 4-point Likert scale (1=not distressing to 4=very distressing) with higher scores indicating greater distress. The total score (reported in this study) is calculated as the average of the item scores, and ranges from 1 to 4, with higher scores indicating greater distress.
Measured: Changes in instrumental activities of daily living distress between the control and intervention conditions will be evaluated across time from T1 (baseline) to T2 (post-intervention completion/6-weeks from baseline) and T3 (45 days from T2).
Cognition - Difficulty
Cognition - Difficulty is an 8-item self-report questionnaire that assesses how much difficulty individuals with dementia experience with their cognition as reported by their caregivers. Example items include How difficult was remembering recent events? and Knowing what day of the week it is? The measure is scored using a 4-point Likert scale (1=not difficult to 4=very difficult) with higher scores indicating more cognitive difficulty. The total score (reported in this study) is calculated as the average of the item scores, and ranges from 1 to 4, with higher scores indicating more cognitive difficulty.
Measured: Changes in cognitive difficulty between the control and intervention conditions will be evaluated across time from T1 (baseline) to T2 (post-intervention completion/6-weeks from baseline) and T3 (45 days from T2).
Cognition - Distress
Cognition - Distress is an 8-item self-report questionnaire that assesses the resulting distress caregivers experience due to the amount of cognitive difficulty experienced by the person they care for. Example items in reference to the person they are caring for include How distressing or upsetting was this for you: Remembering recent events? and Knowing what day of the week it is? The measure is scored using a 4-point Likert scale (1=not distressing to 4=very distressing) with higher scores indicating greater distress. The total score (reported in this study) is calculated as the average of the item scores, and ranges from 1 to 4, with higher scores indicating greater distress.
Measured: Changes in cognitive distress between the control and intervention conditions will be evaluated across time from T1 (baseline) to T2 (post-intervention completion/6-weeks from baseline) and T3 (45 days from T2).
Behaviors - Frequency
Behaviors - Frequency is a 14-item self-report questionnaire that assesses the frequency in which individuals with dementia experience dementia-related behaviors as reported by their caregivers. Example items include How often did the person you care for act confused? and Talk or mumble to himself/herself? The measure is scored using a 4-point Likert scale (1=none of the time to 4=most or all of the time ) with higher scores indicating more frequent behaviors. The total score (reported in this study) is calculated as the average of the item scores, and ranges from 1 to 4, with higher scores indicating more frequent behaviors.
Measured: Changes in behavioral frequency between the control and intervention conditions will be evaluated across time from T1 (baseline) to T2 (post-intervention completion/6-weeks from baseline) and T3 (45 days from T2).
Behaviors - Distress
Behaviors - Distress is a 14-item self-report questionnaire that assesses the resulting distress caregivers experience due to the behaviors of individuals with dementia. Example items in reference to the person they are caring for include How distressing or upsetting was this for you: Act confused? and Talk or mumble to himself/herself? The measure is scored using a 4-point Likert scale (1=not distressing to 4=very distressing) with higher scores indicating greater distress. The total score (reported in this study) is calculated as the average of the item scores, and ranges from 1 to 4, with higher scores indicating greater distress.
Measured: Changes in behavioral distress between the control and intervention conditions will be evaluated across time from T1 (baseline) to T2 (post-intervention completion/6-weeks from baseline) and T3 (45 days from T2).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2023
- Study start18 May 2023
- Primary completion22 Apr 2024
- Study completion22 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DementiaStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 495 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kinto
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Alzheimer's Association
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05916664
- Sponsor's protocol ID
- FT001
- Status last verified
- Feb 2025
- First submitted
- 11 May 2023
- Last updated
- 5 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Efficacy Study of a Technology-enabled Care Coaching Service for Families Caring for AD/ADRD
- ClinicalTrials.gov ID
- NCT05916664
- Acronym / sponsor ID
- FT001
- Conditions
- Dementia, Alzheimer Disease, Lewy Body Disease, Vascular Dementia, Frontotemporal Dementia, Mixed Dementia
- Keywords
- Caregiving, Financial Education, Technology, Behavioral Intervention, Caregiver Support Intervention, Financial Literacy, Financial Preparedness, Caregiver Well Being
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 495 participants (actual)
- Lead sponsor
- KintoIndustry (pharma, biotech, devices)
- Collaborators
- Alzheimer's Association
- Study start
- 18 May 2023 (actual)
- Primary completion
- 22 Apr 2024 (actual)
- Study completion
- 22 Apr 2024 (actual)
- First posted
- 23 Jun 2023 (actual)
- Results
- Posted 5 Mar 2025
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 Kinto's Care Coaching intervention for dementia caregivers.
The main questions it aims to answer are:
Does the intervention help caregivers to address their general caregiving goals Does the intervention help caregivers to address their financial caregiving goals
Participants will have access to:
One-on-one care coaching sessions (via zoom) Up to 6 weekly support groups with other caregivers A variety of digital resources through Kinto's mobile app
Researchers will compare intervention and control groups to see if the program supports caregivers' general and financial caregiving needs.
The efficacy of the intervention also will be examined on key outcomes.
Detailed description
The study will include 300 family caregivers drawn from throughout the US, who will engage remotely with the coaches (and one another) using zoom and Kinto's mobile caregiver app.
Caregivers will be randomly assigned to one of two groups to evaluate the impact of the program by making a comparison of those caregivers who received the program (Group
- and those caregivers who will not receive the program (Group 2). Caregivers assigned to Group 2, the control condition, will be eligible to receive a modified version of the program after completion of the study and data collection protocols.
The intervention is a care coaching program that assists caregivers with their general caregiving goals and financial caregiving goals. Caregivers will attend a one-on-one care coaching session conducted via Zoom for 60-75 minutes with a care coach and will engage with their care coach through chat-based interactions after completing the session. If requested, up to two additional care coaching sessions will be scheduled.
Caregivers also will have the opportunity to attend up to 6 weekly support groups with other caregivers facilitated by a care coach and receive a variety of digital resources through the mobile app.
As guided by the NIH Stage Model for Behavioral Intervention Development, the primary goal of the Phase 2 study is to examine the efficacy of the program on select outcomes for caregivers (i.e., Stage III Real-World Efficacy). As such, the selected data collection periods of T1 (prior to the intervention), T2 (immediately following the initial six week intervention period) and T3 (45 days following this date) will evaluate the immediate and short-term efficacy of the program.
Recruiting of caregivers is scheduled to begin in May 2023. The study plan targets recruitment of three cohorts, each with one hundred participants. The first intervention group will begin the program in August 2023. Subsequent cohorts will begin the study at 8-9 week intervals. The plan includes a contingency to run two additional cohorts (to mitigate any recruitment or retention risk). In the event that all five cohorts are used to achieve participation goals, the final cohort is scheduled to complete the intervention and survey requirements no later than August of 2024.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Kinto Care CoachingThe intervention is a care coaching program that assists caregivers with their general caregiving goals and financial caregiving goals. Caregivers will attend a one-on-one care coaching session conducted via Zoom for 60-75 minutes with a care coach and will engage with their care coach through chat-based interactions after completing the session. If requested, up to two additional care coaching sessions will be scheduled. Caregivers also will have the opportunity to attend up to 6 weekly support groups with other caregivers facilitated by a care coach and receive a variety of digital resources through the mobile app. |
| Control | No intervention | –Control group that does not receive the Caregiver Support Intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 18 years or older
- Caring for a family member or close friend with dementia or memory loss
- Providing 5 or more hours of care or support each week
- Not getting paid for the care/support
- Fluent in English, or both Spanish and English
Key exclusion criteria (3 listed)
- Currently be participating in another non-pharmacological intervention
- Have participated in a previous Kinto study
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 |
|---|---|---|
| Kinto Care CoachingDescribe the basics of the intervention | Behavioural | Intervention |
Primary outcome
Caregiver Mastery
Time frame: Changes in caregiver mastery between the control and intervention conditions will be evaluated across time from T1 (baseline) to T2 (post-intervention completion/6-weeks from baseline) and T3 (45 days from T2).
Caregiver Mastery is a 9-item self-report questionnaire that assesses how competent individuals feel in their role as caregivers of individuals with dementia. Example items include I became more self-confident in providing care and I felt I was pretty good at figuring out what he/she needed. The measure is scored using a 4-point Likert scale (1=strongly disagree to 4=strongly agree) with higher scores indicating greater caregiver mastery. The total score (reported in this study) is calculated as the average of the item scores, and ranges from 1 to 4, with higher scores indicating greater caregiver mastery.
Emotional Health Strain
Time frame: Changes in emotional health strain between the control and intervention conditions will be evaluated across time from T1 (baseline) to T2 (post-intervention completion/6-weeks from baseline) and T3 (45 days from T2).
Emotional Health Strain is a 4-item self-report questionnaire that assesses how emotionally strained individuals feel in their role as caregivers of individuals with dementia. Example items include I was under more stress, strain, or pressure and I was more nervous or bothered by nerves than before. The measure is scored using a 4-point Likert scale (1=strongly disagree to 4=strongly agree) with higher scores indicating more emotional health strain. The total score (reported in this study) is calculated as the average of the item scores, and ranges from 1 to 4, with higher scores indicating greater emotional health strain.
Personal Gain
Time frame: Changes in personal gain between the control and intervention conditions will be evaluated across time from T1 (baseline) to T2 (post-intervention completion/6-weeks from baseline) and T3 (45 days from T2).
Personal Gain is a 4-item self-report questionnaire that assesses the personal gain experienced by individuals in their role as caregivers of individuals with dementia. Example items include Become more aware of your inner strengths and Become more self-confident. The measure is scored using a 4-point Likert scale (1=not at all to 4=a great deal) with higher scores indicating greater personal gain. The total score (reported in this study) is calculated as the average of the item scores, and ranges from 1 to 4, with higher scores indicating greater personal gain.
Financial Self-Efficacy
Time frame: Changes in financial self-efficacy between the control and intervention conditions will be evaluated across time from T1 (baseline) to T2 (post-intervention completion/6-weeks from baseline) and T3 (45 days from T2).
Financial Self-Efficacy is a 10-item self-report questionnaire that assesses how efficacious individuals feel in their financial preparedness and skills for managing money as related to their caregiving role. Example items include I am confident that I will be able to successfully manage my loved one's finances and I feel confident in talking with my loved one about their finances. The measure is scored using a 4-point Likert scale (1=not at all to 4=a great deal) with higher scores indicating greater financial self-efficacy. The total score (reported in this study) is calculated as the average of the item scores, and ranges from 1 to 4, with higher scores indicating greater financial self-efficacy.
ULS-8 Loneliness Scale
Time frame: Changes in loneliness between the control and intervention conditions will be evaluated across time from T1 (baseline) to T2 (post-intervention completion/6-weeks from baseline) and T3 (45 days from T2).
The ULS-8 Loneliness Scale is an 11 item self-report questionnaire that assesses how lonely individuals feel with 8 original items and 3 additional items. Example items include I feel very close to one or more people and There are people who really understand me. The measure is scored using a 4-point Likert scale (1=strongly disagree to 4=strongly agree) with lower scores indicating greater feelings of loneliness. The total score (reported in this study) is calculated as the average of the item scores, and ranges from 1 to 4, with lower scores indicating greater feelings of loneliness.
Perceived Financial Knowledge
Time frame: Changes in perceived financial knowledge between the control and intervention conditions will be evaluated across time from T1 (baseline) to T2 (post-intervention completion/6-weeks from baseline) and T3 (45 days from T2).
Perceived Financial Knowledge is a 1-item self-report questionnaire that assesses an individual's perceived knowledge about their financial preparedness and skills for managing money as related to their caregiving role. The item states Please rate your current understanding of how to manage money for you or the person you are caring for. The measure is scored using a 5-point Likert scale (1=no knowledge to 5=expert knowledge) with higher scores indicating greater perceived financial knowledge.
Caregiver Burden
Time frame: Changes in caregiver burden between the control and intervention conditions will be evaluated across time from T1 (baseline) to T2 (post-intervention completion/6-weeks from baseline) and T3 (45 days from T2).
Caregiver Burden is a 4-item self-report questionnaire that assesses how much strain and stress individuals feel in their caregiving role for individuals with dementia. Example items include Do you feel that because of the time you spend with your relative that you don't have enough time for yourself and Do you feel stressed between caring for your relative and trying to meet other responsibilities (work/family)? The measure is scored using a 5-point Likert scale (1=never to 5=nearly always) with higher scores indicating greater caregiver burden. The total score (reported in this study) is calculated as the average of the item scores, and ranges from 1 to 5, with higher scores indicating greater caregiver burden.
12 secondary outcomes
Dyadic Relationship Strain
Time frame: Changes in relationship strain between the control and intervention conditions will be evaluated across time from T1 (baseline) to T2 (post-intervention completion/6-weeks from baseline) and T3 (45 days from T2).
Role Captivity
Time frame: Changes in role captivity between the control and intervention conditions will be evaluated across time from T1 (baseline) to T2 (post-intervention completion/6-weeks from baseline) and T3 (45 days from T2).
Caregiver Unmet Needs
Time frame: Changes in unmet needs between the control and intervention conditions will be evaluated across time from T1 (baseline) to T2 (post-intervention completion/6-weeks from baseline) and T3 (45 days from T2).
Caregiver Unmet Needs Distress
Time frame: Changes in unmet needs distress between the control and intervention conditions will be evaluated across time from T1 (baseline) to T2 (post-intervention completion/6-weeks from baseline) and T3 (45 days from T2).
Anxiety
Time frame: Changes in anxiety symptoms between the control and intervention conditions will be evaluated across time from T1 (baseline) to T2 (post-intervention completion/6-weeks from baseline) and T3 (45 days from T2).
Depression
Time frame: Changes in depressive symptoms between the control and intervention conditions will be evaluated across time from T1 (baseline) to T2 (post-intervention completion/6-weeks from baseline) and T3 (45 days from T2).
Instrumental and Personal Activities of Daily Living - Difficulty
Time frame: Changes in instrumental activities of daily living difficulty between the control and intervention conditions will be evaluated across time from T1 (baseline) to T2 (post-intervention completion/6-weeks from baseline) and T3 (45 days from T2).
Instrumental and Personal Activities of Daily Living - Distress
Time frame: Changes in instrumental activities of daily living distress between the control and intervention conditions will be evaluated across time from T1 (baseline) to T2 (post-intervention completion/6-weeks from baseline) and T3 (45 days from T2).
Cognition - Difficulty
Time frame: Changes in cognitive difficulty between the control and intervention conditions will be evaluated across time from T1 (baseline) to T2 (post-intervention completion/6-weeks from baseline) and T3 (45 days from T2).
Cognition - Distress
Time frame: Changes in cognitive distress between the control and intervention conditions will be evaluated across time from T1 (baseline) to T2 (post-intervention completion/6-weeks from baseline) and T3 (45 days from T2).
Behaviors - Frequency
Time frame: Changes in behavioral frequency between the control and intervention conditions will be evaluated across time from T1 (baseline) to T2 (post-intervention completion/6-weeks from baseline) and T3 (45 days from T2).
Behaviors - Distress
Time frame: Changes in behavioral distress between the control and intervention conditions will be evaluated across time from T1 (baseline) to T2 (post-intervention completion/6-weeks from baseline) and T3 (45 days from T2).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kinto Care Coaching in people with Dementia and Alzheimer Disease, run by Kinto 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 9 inclusion and 3 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 5 Mar 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?
Yes. Results are posted in the registry (first posted 5 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Caregiver Mastery (time frame: Changes in caregiver mastery between the control and intervention conditions will be evaluated across time from T1 (baseline) to T2 (post-intervention completion/6-weeks from baseline) and T3 (45 days from T2).). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Mar 2025; AzTrials last refreshed its copy on 8 Nov 2026.