DementiaFamTechCareNCT02483520
Supporting Family Caregivers With Technology for Dementia Home Care
A study testing FamTechCare in people with Dementia, run by University of Kansas Medical Center at 2 sites in United States.
Trial summary
This clinical trial will test the FamTechCare intervention that uses multidisciplinary professional guidance based on in-home video monitoring to support family caregivers in managing challenging behaviors of persons with dementia (PWD). Families provide the majority of care for PWD at home. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dementia
- What is being tested?
- FamTechCare
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 189 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2014to 31 Jan 2019
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Person caring for someone with a diagnosis of Alzheimer's disease or other dementia at home.
Who cannot join
- Exclusion criteria include Huntington's disease, alcohol-related dementia, schizophrenia, manic-depressive disorder, deafness, and mental retardation.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Iowa College of Nursing
Iowa City, Iowa, 52242
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
This clinical trial will test the FamTechCare intervention that uses multidisciplinary professional guidance based on in-home video monitoring to support family caregivers in managing challenging behaviors of persons with dementia (PWD). Families provide the majority of care for PWD at home. However the stress of caregiving is so significant that it increases caregiver morbidity and mortality. Stress is magnified by disruptive behaviors in PWD that frequently lead to nursing home placement. In-home video monitoring allows experts to assess behaviors of PWD and to identify antecedents, recommend specific interventions. FamTechCare uses new technology to link family caregivers to experts for guidance in managing disruptive behaviors, supporting continued care at home while reducing the negative effects of caregiving.
Caregiver-PWD dyads (N=88) will be randomly assigned to intervention or control groups. Both groups will record behaviors during daily care for 3 months using a home monitoring unit. Notably, this new technology captures 3-5 minutes prior to the behavior, thus recording behavior triggers and precursors. Caregivers record care situations they select and upload videos to a secure site. The expert team will review intervention group videos weekly and will provide individualized feedback for improving care to caregivers in the home. The control group caregivers will receive a weekly phone call and advice from a nurse, but their recorded videos will be held for review and individualized feedback provided after 3 months.
Study aims are to use observation to assist caregivers in behavior management. Effects on disruptive behaviors and caregiver burden and other negative outcomes will be compared. Investigators will evaluate ease of use and satisfaction, cost-efficiency, and factors influencing likelihood of translation into practice. This is the first study to test new technology for direct observation and immediate feedback to empower families to manage PWD behaviors at home while reducing caregiver stress and morbidity. Technology links caregivers to individualized expert guidance, acknowledging the importance and burden of their role. This study addresses NIH missions and the 2012 National Plan to Address Alzheimer's disease goals, integrating strategies to promote adoption and use of aging services technologies in interventions that will reduce negative caregiver outcomes, a growing public health problem.
Read the detailed description
This clinical trial will test the FamTechCare intervention that uses multidisciplinary professional guidance based on in-home video monitoring to support family caregivers in managing behaviors of persons with dementia (PWD). Families provide the majority of care for PWD at home. However the stress of caregiving is so significant that it increases caregiver morbidity and mortality. Stress is magnified by disruptive behaviors that frequently lead to nursing home placement. In-home video monitoring allows experts to assess behaviors of PWD and to identify antecedents, recommend specific interventions, and subsequently evaluate caregiver outcomes. FamTechCare uses new technology to link family caregivers to experts for guidance in managing disruptive behaviors, supporting continued care at home while reducing the negative effects of caregiving.
Caregiver-PWD dyads (N=88) will be randomly assigned to intervention or control groups. Both groups will record behaviors during daily care for 3 months using a home monitoring unit. Notably, this new technology captures 3-5 minutes prior to the behavior, thus recording behavior triggers and precursors. Intervention group videos will be auto-uploaded to a Health Insurance Portability and Accountability Act (HIPAA) secure Internet site for weekly team review with in-home feedback to caregivers in behavior management. The time and attention equivalent control group will receive a weekly phone call from a nurse, but their recorded videos will be held for review and feedback after 3 months.
Study aims are to identify interventions, based on in-home observations, to assist caregivers in behavior management. Between-group effects on outcomes, including PWD disruptive behaviors and caregiver burden and other negative outcomes will be compared using linear mixed modeling. Ease of use and satisfaction, cost-efficiency, and factors influencing likelihood of translation into practice will be evaluated. This tests new technology for direct observation and immediate feedback to empower families to manage PWD behaviors at home while reducing caregiver stress and morbidity. Technology links caregivers to individualized expert guidance, acknowledging the importance and burden of their role. This study addresses NIH missions and the 2012 National Plan to Address Alzheimer's disease goals, integrating strategies to promote adoption and use of aging services technologies in interventions that will reduce negative caregiver outcomes, a growing public health problem.
- Conditions
- Dementia
- Being tested
- FamTechCare
- Keywords
- Family caregiver
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FamTechCareBehavioural
Caregiver submitted videos of challenging care situations are uploaded to a HIPAA secure site and reviewed by dementia care experts who provide feedback for improving care.
| Study group | Role | What they receive |
|---|---|---|
| Intervention FamTechCare | Experimental | This group will submit videos and receive weekly feed back after review by dementia care experts for managing challenging care situations. The intervention is weekly individualized feedback based on video data (FamTechCare). Receives: Behavioral: FamTechCare |
| Control and Delayed FamTechCare | Placebo comparator | This group will submit videos and will receive weekly feedback from a nurse based on their verbal communication until the end of their participation. At the end of the study, they will receive feedback based on submitted videos from dementia care experts (delayed FamTechCare). Receives: Behavioral: FamTechCare |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Behaviorally Coded Challenging Behaviors (Agitated, Disruptive, Resistive)
Behavioral coding of videos for agitated, disruptive, or resistive behaviors will be used to identity changes in behavior before and after the intervention.
Measured: 3 months
Change in Caregiver Stress - Reaction to Memory Symptoms (Bother)
Caregiver reaction to behavioral symptoms of the Person with Dementia (PWD) was measured by the Revised Memory and Problem Behavior Checklist (RMPBC). The RMPBC contains 24 items, each with two parts. Each item represents a behavior; if the behavior has been exhibited by the PWD in the past week, the caregiver reports the behavior as present. If the behavior is present, the caregiver then reports "how much it bothered you?" on a five-point Likert scale (0 = not at all; 4 = extremely). If the behavior was not present, no "bother" score is provided, and the item is scored 0. The items are summed for a total score (range = 0-96) and for three subscales representing bother due to memory-related problems (range = 0-28), depressive symptoms (range = 0-36), and disruptive symptoms (range = 0-32). A higher score indicates a greater negative reaction to behaviors.
Measured: Baseline, 1 month, 3 months
Change in Caregiver Stress - Reaction to Depressive Symptoms (Bother)
Caregiver reaction to behavioral symptoms of the person with dementia (PWD) was measured by the Revised Memory and Problem Behavior Checklist (RMPBC). The RMPBC contains 24 items, each with two parts. Each item represents a behavior; if the behavior has been exhibited by the PWD in the past week, the caregiver reports the behavior as present. If the behavior is present, the caregiver then reports "how much it bothered you?" on a five-point Likert scale (0 = not at all; 4 = extremely). If the behavior was not present, no "bother" score is provided, and the item is scored 0. The items are summed for a total score (range = 0-96) and for three subscales representing bother due to memory-related problems (range = 0-28), depressive symptoms (range = 0-36), and disruptive symptoms (range = 0-32). A higher score indicates a greater negative reaction to behaviors.
Measured: Baseline, 1 month, 3 months
Change in Caregiver Stress - Desire to Instituionalize
Desire to institutionalize was measured using a modified Desire to Institutionalize Scale. The modified Desire to Institutionalize Scale contains six items rated as dichotomous yes or no (1 = yes; 0 = no). A higher score indicates a greater desire to institutionalize (range = 0-6). Internal consistency for the Desire to Institutionalize scale is adequate (α = .69-.77) and has shown adequate construct validity through factor analysis.
Measured: Baseline, 1 month, 3 months
Change in Caregiver Stress - Biological Sensor Data
Biological stress reactions measured by sensor
Measured: Baseline, 1 month, 3 months
Change in Caregiver Burden
Caregiver burden was measured using the Modified Zarit Burden Scale that contains 12 items with a 5-point Likert scale (0 = never; 4 = nearly always) adapted from the 22-item Zarit Burden Interview. A higher score indicates greater caregiver burden (range = 0-48). The Modified Zarit Burden Scale has shown adequate internal consistency (α = .88) and excellent concurrent validity (r = .92- .97) with the full Zarit Burden Interview.
Measured: Baseline, 1 month, 3 months
Change in Caregiver Health and Wellbeing - Depression
Caregiver depression was measured using the Center for Epidemiologic Studies Depression scale (CES-D). The CES-D contains 20 items with a 4-point Likert scale ranging from 0 = rarely or none of the time (i.e., less than 1 day in past week) to 3 = most or all of the time (i.e., 5-7 days in past week). A higher score indicates greater depression (range = 0-60). The CES-D shows adequate internal consistency (α = .84-.90), moderate convergent validity with other depression scales (r = .44-.75), and has been shown to effectively measure change in psychoeducational interventions for dementia caregivers.
Measured: Baseline, 1 month, 3 months
Change in Caregiver Health and Wellbeing - Competence
Caregiver sense of competence was measured using the Short Sense of Competence Questionnaire (SSCQ).37 The SSCQ contains seven negatively worded items (e.g., "I feel strained in my interaction with..."). Each item is rated on a five-point Likert scale and dichotomized to agree (i.e., agree very strongly, agree, neutral) or disagree (i.e., disagree or strongly disagree). The items where the caregiver disagreed are summed for the total score. A higher score indicates a higher sense of competence (range = 0-7). The SSCQ shows adequate internal consistency (α = .76) and concurrent validity with the original Sense of Competence Questionnaire (r = .88).
Measured: Baseline, 1 month, 3 months
Change in Caregiver Health and Wellbeing - Sleep Disturbance
Caregiver sleep disturbance was measured by the Pittsburgh Sleep Quality Index (PSQI). The PSQI contains 19 items with a 4-point Likert scale across seven domains: sleep quality, sleep latency, sleep duration, habitual sleep ef- ficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction. A higher global score indicates worse sleep quality (range = 0-21). The PSQI shows adequate internal consistency (α = .83) and adequate validity in differentiating patients with and without sleep disorders.
Measured: Baseline, 1 month, 3 months
Change in Caregiver Health and Wellbeing - Medication Use
Caregivers taking PRN anxiolytics, hypnotics, or antipsychotic medication.
Measured: Baseline, 1 month, 3 months
Change in Caregiver Health and Wellbeing - Confidence in Managing BPSD
Caregivers reported their three priority care challenges at baseline using the Caregiver Target Problems Questionnaire (Teri, McCurry, Logsdon, \& Gibbons, 2005). The Caregiver Target Problems Questionnaire was adapted and used to identify caregiver priority care challenges for frequency, severity, and confidence at baseline and 3-months (Teri et al., 2005). Prior to group allocation, caregivers identified three priority care challenges and rated them on 5-point Likert scales: frequency of the challenge (0 = None to 4 = Daily or more often), severity of the challenge (0 = Trivial to 4 = Severe), and confidence in managing the challenge (0 = Unable to manage to 4 = Very confident). At the end of the 3-month trial, caregivers repeated their ratings of the baseline care challenges. Improvement was indicated increase in confidence from baseline to 3-months.
Measured: Baseline, 3 months
Change in Caregiver Health and Wellbeing - Confidence in Managing Disease Expectations
Caregivers reported their three priority care challenges at baseline using the Caregiver Target Problems Questionnaire (Teri, McCurry, Logsdon, \& Gibbons, 2005). The Caregiver Target Problems Questionnaire was adapted and used to identify caregiver priority care challenges for frequency, severity, and confidence at baseline and 3-months (Teri et al., 2005). Prior to group allocation, caregivers identified three priority care challenges and rated them on 5-point Likert scales: frequency of the challenge (0 = None to 4 = Daily or more often), severity of the challenge (0 = Trivial to 4 = Severe), and confidence in managing the challenge (0 = Unable to manage to 4 = Very confident). At the end of the 3-month trial, caregivers repeated their ratings of the baseline care challenges. Improvement was indicated increase in confidence from baseline to 3-months.
Measured: Baseline, 3 months
Change in Caregiver Health and Wellbeing - Confidence in Managing ADLs (Activities of Daily Living)
Caregivers reported their three priority care challenges at baseline using the Caregiver Target Problems Questionnaire (Teri, McCurry, Logsdon, \& Gibbons, 2005). The Caregiver Target Problems Questionnaire was adapted and used to identify caregiver priority care challenges for frequency, severity, and confidence at baseline and 3-months (Teri et al., 2005). Prior to group allocation, caregivers identified three priority care challenges and rated them on 5-point Likert scales: frequency of the challenge (0 = None to 4 = Daily or more often), severity of the challenge (0 = Trivial to 4 = Severe), and confidence in managing the challenge (0 = Unable to manage to 4 = Very confident). At the end of the 3-month trial, caregivers repeated their ratings of the baseline care challenges. Improvement was indicated increase in confidence from baseline to 3-months.
Measured: Baseline, 3 months
Change in Caregiver Reported Challenging Behaviors - Reaction to Disruptive Symptoms (Bother)
Caregiver reaction to behavioral symptoms of the PLWD was measured by the Revised Memory and Problem Behavior Checklist (RMPBC). The RMPBC contains 24 items, each with two parts. Each item represents a behavior; if the behavior has been exhibited by the PLWD in the past week, the caregiver reports the behavior as present. If the behavior is present, the caregiver then reports "how much it bothered you?" on a five-point Likert scale (0 = not at all; 4 = extremely). If the behavior was not present, no "bother" score is provided, and the item is scored 0. The items are summed for a total score (range = 0-96) and for three subscales representing bother due to memory-related problems (range = 0-28), depressive symptoms (range = 0-36), and disruptive symptoms (range = 0-32). A higher score indicates a greater negative reaction to behaviors.
Measured: Baseline, 1 month, 3 months
Change in Caregiver Reported Challenging Behaviors - Frequency of Disruptive Behaviors
Frequency of disruptive behaviors measured by the Revised Memory and Problem Behavior Checklist (RMPBC). The RMPBC contains 24 items. Each item represents a behavior; if the behavior has been exhibited by the person with dementia in the past week, the caregiver reports the behavior as present. There are 8 disruptive behaviors questions. Range is 0-8. A decrease in disruptive behaviors is an improvement.
Measured: Baseline, 1 month, 3 months
Secondary outcomes (2)
Cost for FamTechCare Treatment Compared to Control Group
Process-based costing for the FamTechCare group compared to the control group. Costs reflect the total cost for the program per dyad per week.
Measured: 3 months
Cost for FamTechCare Treatment Compared to Control Group - ICER
Incremental Cost-effectiveness Ratio (ICER) for Significant Primary Outcomes: Depression and Competence. Costs reflect the total cost for the program per dyad per week to achieve effect in each outcome.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2015 (estimated)
- Study startMar 2014
- Primary completion31 Jan 2019
- Study completion31 Jan 2019
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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 189 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Sponsor
- Investigators
- Kristine N Williams, RN, PhD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02483520
- Sponsor's protocol ID
- STUDY00000053
- Other IDs
- R01NR014737
- Acronym
- FamTechCare
- Status last verified
- Oct 2020
- First submitted
- 4 Jun 2015
- Last updated
- 13 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Williams K, Arthur A, Niedens M, Moushey L, Hutfles L. In-home monitoring support for dementia caregivers: a feasibility study. Clin Nurs Res. 2013 May;22(2):139-50. doi: 10.1177/1054773812460545. Epub 2012 Sep 20.
PubMed 22997349Kim S, Shaw C, Williams KN, Hein M. Typology of Technology-Supported Dementia Care Interventions From an In-Home Telehealth Trial. West J Nurs Res. 2019 Dec;41(12):1724-1746. doi: 10.1177/0193945919825861. Epub 2019 Jan 28.
PubMed 30688175
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supporting Family Caregivers With Technology for Dementia Home Care
- ClinicalTrials.gov ID
- NCT02483520
- Acronym / sponsor ID
- FamTechCare / STUDY00000053
- Conditions
- Dementia
- Keywords
- Family caregiver
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 189 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- Mar 2014
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 31 Jan 2019 (actual)
- First posted
- 29 Jun 2015 (estimated)
- Results
- Posted 13 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial will test the FamTechCare intervention that uses multidisciplinary professional guidance based on in-home video monitoring to support family caregivers in managing challenging behaviors of persons with dementia (PWD). Families provide the majority of care for PWD at home. However the stress of caregiving is so significant that it increases caregiver morbidity and mortality. Stress is magnified by disruptive behaviors in PWD that frequently lead to nursing home placement. In-home video monitoring allows experts to assess behaviors of PWD and to identify antecedents, recommend specific interventions. FamTechCare uses new technology to link family caregivers to experts for guidance in managing disruptive behaviors, supporting continued care at home while reducing the negative effects of caregiving.
Caregiver-PWD dyads (N=88) will be randomly assigned to intervention or control groups. Both groups will record behaviors during daily care for 3 months using a home monitoring unit. Notably, this new technology captures 3-5 minutes prior to the behavior, thus recording behavior triggers and precursors. Caregivers record care situations they select and upload videos to a secure site. The expert team will review intervention group videos weekly and will provide individualized feedback for improving care to caregivers in the home. The control group caregivers will receive a weekly phone call and advice from a nurse, but their recorded videos will be held for review and individualized feedback provided after 3 months.
Study aims are to use observation to assist caregivers in behavior management. Effects on disruptive behaviors and caregiver burden and other negative outcomes will be compared. Investigators will evaluate ease of use and satisfaction, cost-efficiency, and factors influencing likelihood of translation into practice. This is the first study to test new technology for direct observation and immediate feedback to empower families to manage PWD behaviors at home while reducing caregiver stress and morbidity. Technology links caregivers to individualized expert guidance, acknowledging the importance and burden of their role. This study addresses NIH missions and the 2012 National Plan to Address Alzheimer's disease goals, integrating strategies to promote adoption and use of aging services technologies in interventions that will reduce negative caregiver outcomes, a growing public health problem.
Detailed description
This clinical trial will test the FamTechCare intervention that uses multidisciplinary professional guidance based on in-home video monitoring to support family caregivers in managing behaviors of persons with dementia (PWD). Families provide the majority of care for PWD at home. However the stress of caregiving is so significant that it increases caregiver morbidity and mortality. Stress is magnified by disruptive behaviors that frequently lead to nursing home placement. In-home video monitoring allows experts to assess behaviors of PWD and to identify antecedents, recommend specific interventions, and subsequently evaluate caregiver outcomes. FamTechCare uses new technology to link family caregivers to experts for guidance in managing disruptive behaviors, supporting continued care at home while reducing the negative effects of caregiving.
Caregiver-PWD dyads (N=88) will be randomly assigned to intervention or control groups. Both groups will record behaviors during daily care for 3 months using a home monitoring unit. Notably, this new technology captures 3-5 minutes prior to the behavior, thus recording behavior triggers and precursors. Intervention group videos will be auto-uploaded to a Health Insurance Portability and Accountability Act (HIPAA) secure Internet site for weekly team review with in-home feedback to caregivers in behavior management. The time and attention equivalent control group will receive a weekly phone call from a nurse, but their recorded videos will be held for review and feedback after 3 months.
Study aims are to identify interventions, based on in-home observations, to assist caregivers in behavior management. Between-group effects on outcomes, including PWD disruptive behaviors and caregiver burden and other negative outcomes will be compared using linear mixed modeling. Ease of use and satisfaction, cost-efficiency, and factors influencing likelihood of translation into practice will be evaluated. This tests new technology for direct observation and immediate feedback to empower families to manage PWD behaviors at home while reducing caregiver stress and morbidity. Technology links caregivers to individualized expert guidance, acknowledging the importance and burden of their role. This study addresses NIH missions and the 2012 National Plan to Address Alzheimer's disease goals, integrating strategies to promote adoption and use of aging services technologies in interventions that will reduce negative caregiver outcomes, a growing public health problem.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention FamTechCare | Experimental | Behavioral: FamTechCareThis group will submit videos and receive weekly feed back after review by dementia care experts for managing challenging care situations. The intervention is weekly individualized feedback based on video data (FamTechCare). |
| Control and Delayed FamTechCare | Placebo comparator | Behavioral: FamTechCareThis group will submit videos and will receive weekly feedback from a nurse based on their verbal communication until the end of their participation. At the end of the study, they will receive feedback based on submitted videos from dementia care experts (delayed FamTechCare). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Person caring for someone with a diagnosis of Alzheimer's disease or other dementia at home.
Key exclusion criteria (1 listed)
- Exclusion criteria include Huntington's disease, alcohol-related dementia, schizophrenia, manic-depressive disorder, deafness, and mental retardation.
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 |
|---|---|---|
| FamTechCareCaregiver submitted videos of challenging care situations are uploaded to a HIPAA secure site and reviewed by dementia care experts who provide feedback for improving care. | Behavioural | Control and Delayed FamTechCare, Intervention FamTechCare |
Primary outcome
Change in Behaviorally Coded Challenging Behaviors (Agitated, Disruptive, Resistive)
Time frame: 3 months
Behavioral coding of videos for agitated, disruptive, or resistive behaviors will be used to identity changes in behavior before and after the intervention.
Change in Caregiver Stress - Reaction to Memory Symptoms (Bother)
Time frame: Baseline, 1 month, 3 months
Caregiver reaction to behavioral symptoms of the Person with Dementia (PWD) was measured by the Revised Memory and Problem Behavior Checklist (RMPBC). The RMPBC contains 24 items, each with two parts. Each item represents a behavior; if the behavior has been exhibited by the PWD in the past week, the caregiver reports the behavior as present. If the behavior is present, the caregiver then reports "how much it bothered you?" on a five-point Likert scale (0 = not at all; 4 = extremely). If the behavior was not present, no "bother" score is provided, and the item is scored 0. The items are summed for a total score (range = 0-96) and for three subscales representing bother due to memory-related problems (range = 0-28), depressive symptoms (range = 0-36), and disruptive symptoms (range = 0-32). A higher score indicates a greater negative reaction to behaviors.
Change in Caregiver Stress - Reaction to Depressive Symptoms (Bother)
Time frame: Baseline, 1 month, 3 months
Caregiver reaction to behavioral symptoms of the person with dementia (PWD) was measured by the Revised Memory and Problem Behavior Checklist (RMPBC). The RMPBC contains 24 items, each with two parts. Each item represents a behavior; if the behavior has been exhibited by the PWD in the past week, the caregiver reports the behavior as present. If the behavior is present, the caregiver then reports "how much it bothered you?" on a five-point Likert scale (0 = not at all; 4 = extremely). If the behavior was not present, no "bother" score is provided, and the item is scored 0. The items are summed for a total score (range = 0-96) and for three subscales representing bother due to memory-related problems (range = 0-28), depressive symptoms (range = 0-36), and disruptive symptoms (range = 0-32). A higher score indicates a greater negative reaction to behaviors.
Change in Caregiver Stress - Desire to Instituionalize
Time frame: Baseline, 1 month, 3 months
Desire to institutionalize was measured using a modified Desire to Institutionalize Scale. The modified Desire to Institutionalize Scale contains six items rated as dichotomous yes or no (1 = yes; 0 = no). A higher score indicates a greater desire to institutionalize (range = 0-6). Internal consistency for the Desire to Institutionalize scale is adequate (α = .69-.77) and has shown adequate construct validity through factor analysis.
Change in Caregiver Stress - Biological Sensor Data
Time frame: Baseline, 1 month, 3 months
Biological stress reactions measured by sensor
Change in Caregiver Burden
Time frame: Baseline, 1 month, 3 months
Caregiver burden was measured using the Modified Zarit Burden Scale that contains 12 items with a 5-point Likert scale (0 = never; 4 = nearly always) adapted from the 22-item Zarit Burden Interview. A higher score indicates greater caregiver burden (range = 0-48). The Modified Zarit Burden Scale has shown adequate internal consistency (α = .88) and excellent concurrent validity (r = .92- .97) with the full Zarit Burden Interview.
Change in Caregiver Health and Wellbeing - Depression
Time frame: Baseline, 1 month, 3 months
Caregiver depression was measured using the Center for Epidemiologic Studies Depression scale (CES-D). The CES-D contains 20 items with a 4-point Likert scale ranging from 0 = rarely or none of the time (i.e., less than 1 day in past week) to 3 = most or all of the time (i.e., 5-7 days in past week). A higher score indicates greater depression (range = 0-60). The CES-D shows adequate internal consistency (α = .84-.90), moderate convergent validity with other depression scales (r = .44-.75), and has been shown to effectively measure change in psychoeducational interventions for dementia caregivers.
Change in Caregiver Health and Wellbeing - Competence
Time frame: Baseline, 1 month, 3 months
Caregiver sense of competence was measured using the Short Sense of Competence Questionnaire (SSCQ).37 The SSCQ contains seven negatively worded items (e.g., "I feel strained in my interaction with..."). Each item is rated on a five-point Likert scale and dichotomized to agree (i.e., agree very strongly, agree, neutral) or disagree (i.e., disagree or strongly disagree). The items where the caregiver disagreed are summed for the total score. A higher score indicates a higher sense of competence (range = 0-7). The SSCQ shows adequate internal consistency (α = .76) and concurrent validity with the original Sense of Competence Questionnaire (r = .88).
Change in Caregiver Health and Wellbeing - Sleep Disturbance
Time frame: Baseline, 1 month, 3 months
Caregiver sleep disturbance was measured by the Pittsburgh Sleep Quality Index (PSQI). The PSQI contains 19 items with a 4-point Likert scale across seven domains: sleep quality, sleep latency, sleep duration, habitual sleep ef- ficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction. A higher global score indicates worse sleep quality (range = 0-21). The PSQI shows adequate internal consistency (α = .83) and adequate validity in differentiating patients with and without sleep disorders.
Change in Caregiver Health and Wellbeing - Medication Use
Time frame: Baseline, 1 month, 3 months
Caregivers taking PRN anxiolytics, hypnotics, or antipsychotic medication.
Change in Caregiver Health and Wellbeing - Confidence in Managing BPSD
Time frame: Baseline, 3 months
Caregivers reported their three priority care challenges at baseline using the Caregiver Target Problems Questionnaire (Teri, McCurry, Logsdon, \& Gibbons, 2005). The Caregiver Target Problems Questionnaire was adapted and used to identify caregiver priority care challenges for frequency, severity, and confidence at baseline and 3-months (Teri et al., 2005). Prior to group allocation, caregivers identified three priority care challenges and rated them on 5-point Likert scales: frequency of the challenge (0 = None to 4 = Daily or more often), severity of the challenge (0 = Trivial to 4 = Severe), and confidence in managing the challenge (0 = Unable to manage to 4 = Very confident). At the end of the 3-month trial, caregivers repeated their ratings of the baseline care challenges. Improvement was indicated increase in confidence from baseline to 3-months.
Change in Caregiver Health and Wellbeing - Confidence in Managing Disease Expectations
Time frame: Baseline, 3 months
Caregivers reported their three priority care challenges at baseline using the Caregiver Target Problems Questionnaire (Teri, McCurry, Logsdon, \& Gibbons, 2005). The Caregiver Target Problems Questionnaire was adapted and used to identify caregiver priority care challenges for frequency, severity, and confidence at baseline and 3-months (Teri et al., 2005). Prior to group allocation, caregivers identified three priority care challenges and rated them on 5-point Likert scales: frequency of the challenge (0 = None to 4 = Daily or more often), severity of the challenge (0 = Trivial to 4 = Severe), and confidence in managing the challenge (0 = Unable to manage to 4 = Very confident). At the end of the 3-month trial, caregivers repeated their ratings of the baseline care challenges. Improvement was indicated increase in confidence from baseline to 3-months.
Change in Caregiver Health and Wellbeing - Confidence in Managing ADLs (Activities of Daily Living)
Time frame: Baseline, 3 months
Caregivers reported their three priority care challenges at baseline using the Caregiver Target Problems Questionnaire (Teri, McCurry, Logsdon, \& Gibbons, 2005). The Caregiver Target Problems Questionnaire was adapted and used to identify caregiver priority care challenges for frequency, severity, and confidence at baseline and 3-months (Teri et al., 2005). Prior to group allocation, caregivers identified three priority care challenges and rated them on 5-point Likert scales: frequency of the challenge (0 = None to 4 = Daily or more often), severity of the challenge (0 = Trivial to 4 = Severe), and confidence in managing the challenge (0 = Unable to manage to 4 = Very confident). At the end of the 3-month trial, caregivers repeated their ratings of the baseline care challenges. Improvement was indicated increase in confidence from baseline to 3-months.
Change in Caregiver Reported Challenging Behaviors - Reaction to Disruptive Symptoms (Bother)
Time frame: Baseline, 1 month, 3 months
Caregiver reaction to behavioral symptoms of the PLWD was measured by the Revised Memory and Problem Behavior Checklist (RMPBC). The RMPBC contains 24 items, each with two parts. Each item represents a behavior; if the behavior has been exhibited by the PLWD in the past week, the caregiver reports the behavior as present. If the behavior is present, the caregiver then reports "how much it bothered you?" on a five-point Likert scale (0 = not at all; 4 = extremely). If the behavior was not present, no "bother" score is provided, and the item is scored 0. The items are summed for a total score (range = 0-96) and for three subscales representing bother due to memory-related problems (range = 0-28), depressive symptoms (range = 0-36), and disruptive symptoms (range = 0-32). A higher score indicates a greater negative reaction to behaviors.
Change in Caregiver Reported Challenging Behaviors - Frequency of Disruptive Behaviors
Time frame: Baseline, 1 month, 3 months
Frequency of disruptive behaviors measured by the Revised Memory and Problem Behavior Checklist (RMPBC). The RMPBC contains 24 items. Each item represents a behavior; if the behavior has been exhibited by the person with dementia in the past week, the caregiver reports the behavior as present. There are 8 disruptive behaviors questions. Range is 0-8. A decrease in disruptive behaviors is an improvement.
2 secondary outcomes
Cost for FamTechCare Treatment Compared to Control Group
Time frame: 3 months
Cost for FamTechCare Treatment Compared to Control Group - ICER
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22997349Williams K, Arthur A, Niedens M, Moushey L, Hutfles L. In-home monitoring support for dementia caregivers: a feasibility study. Clin Nurs Res. 2013 May;22(2):139-50. doi: 10.1177/1054773812460545. Epub 2012 Sep 20.
- Derived from this study: PubMed 30688175Kim S, Shaw C, Williams KN, Hein M. Typology of Technology-Supported Dementia Care Interventions From an In-Home Telehealth Trial. West J Nurs Res. 2019 Dec;41(12):1724-1746. doi: 10.1177/0193945919825861. Epub 2019 Jan 28.
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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.
Kristine N Williams, RN, PhD principal investigator
University of Kansas Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FamTechCare in people with Dementia, run by University of Kansas Medical Center at 2 sites 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 1 inclusion and 1 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 13 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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 13 Nov 2020). 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?
Change in Behaviorally Coded Challenging Behaviors (Agitated, Disruptive, Resistive) (time frame: 3 months). The study lists 15 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 NCT02483520, which also lists 2 linked publications.
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 13 Nov 2020.