Coaching Dementia Caregivers to Master Care-Resistant Behavior

Study Overview
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Brief Summary
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266 family caregivers will be randomly assigned to either immediate intervention or delayed intervention groups. All caregivers will complete baseline surveys and 3 weeks of daily diaries. The immediate intervention group will receive 12 weeks of CuRB-IT. They will complete 3 rounds of 3-week daily diaries followed by an intermittent survey at 12 week intervals for the next 33 weeks. The delayed intervention group will receive 12 weeks of attention, complete 1 round of 3-week daily diaries followed by an intermittent survey, then complete 12 weeks of CuRB-IT, and complete 2 rounds of 3--week daily diaries followed by an intermittent survey at 12-week intervals for the next 18 weeks.

Detailed Description
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The purposes of the delayed-intervention randomized clinical trial (N=266) are to: Care-Resistant Behavior Internet Training (CuRB-IT). examine the efficacy of CuRB-IT in increasing the self-efficacy of family caregivers of persons living with dementia to handle care-resistant behaviors (CRB); further test the efficacy of CuRB-IT in improving caregivers coping strategies (a) among the experimental (immediate-intervention group) as compared to the control (delayed-intervention group) (between groups) and (b) within-person from pre- to post- intervention; examine intervention decay at 3- and 6-months post intervention to determine performance of intervention and inform scheduling of booster sessions; assess the efficacy of the CuRB-IT intervention in preventing onset of poor coping strategies by family caregivers; test the hypothesized mechanism of action that increased CRB self-efficacy and use of CuRB-IT problem-focused coping strategies mediate the relationship between CRB stress appraisal and caregiving activities.

Official Title
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Coaching Dementia Caregivers to Master Care-Resistant Behavior and Improve Coping Strategies

Conditions
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Care-resistant Behavior, Dementia

Intervention / Treatment
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* Behavioral: CuRB-IT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1)Caregiver of any race or gender who is aged >18 years 2) provides unpaid care, 3) cares for a spouse/common-law, parent or grandparent (or in-law, aged 60+ years), 4) lives with or shares cooking facilities with the care recipient, 5) Care recipient has mild cognitive impairment or dementia as identified using the Quick Dementia Rating System instrument, 6) the care provided consists of help with at least 2 Instrumental Activities of Daily Living or one Activity of Daily Living, 7) the care recipient is resistant to receiving assistance with, or refuses to do, at least one instrumental or activity of daily living Exclusion Criteria: 1) persons who cannot speak/read English 2) who do not have reliable access to a smart phone or internet

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immediate Intervention<br>Complete baseline survey, complete 3 weeks of daily diaries and intermittent survey, receive 12 weeks of CurB-IT, then complete 3 rounds of 21-day daily diaries and intermittent surveys while receiving attention during the 12-week intervals between daily diaries. | Behavioral: CuRB-IT<br>* 9 1-hour coaching sessions delivered over a videoconferencing platform (Zoom); 6 delivered weekly, 3 delivered biweekly<br>|
| Active Comparator: Delayed intervention<br>Complete baseline survey, complete 3 weeks of daily diaries, receive 12 weeks of attention, complete 3 weeks of daily diaries and 1 intermittent survey, receive 12 weeks of CurB-IT, then complete 2 rounds of 21-day daily diaries and intermittent surveys while receiving attention during the 12-week intervals between daily diaries. | Behavioral: CuRB-IT<br>* 9 1-hour coaching sessions delivered over a videoconferencing platform (Zoom); 6 delivered weekly, 3 delivered biweekly<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in frequency of care-resistant behaviors and other dementia-related behaviors measured by a 19-item self-report scale (yes/no) for dementia family caregivers | Experimental and control | Daily during weeks 1, 2, and 3 | 
| Change in frequency of care-resistant behaviors and other dementia-related behaviors measured by a 19-item self-report scale (yes/no) for dementia family caregivers | Experimental and control | Daily during weeks 15, 16, and 17 | 
| Change in frequency of care-resistant behaviors and other dementia-related behaviors measured by a 19-item self-report scale (yes/no) for dementia family caregivers | Experimental and control | Daily during weeks 37, 38, and 39 | 
| Change in frequency of care-resistant behaviors and other dementia-related behaviors measured by a 19-item self-report scale (yes/no) for dementia family caregivers | Experimental and control | Daily during weeks 49, 50, and 51 | 
| Change in caregiver responses to dementia-related behaviors | Experimental (immediate) and control (delayed intervention). Measured using yes/no responses to 8 items (2 from the Conflicts Tactics Scale Revised, 2 from the Conflicts Tactics Scale modified for Older Adults, and 4 from the Conflict Tactics Scale for Child Mistreatment). | Immediately after enrollment | 
| Change in caregiver responses to dementia-related behaviors | Experimental (immediate) and control (delayed intervention). Measured using yes/no responses to 8 items (2 from the Conflicts Tactics Scale Revised, 2 from the Conflicts Tactics Scale modified for Older Adults, and 4 from the Conflict Tactics Scale for Child Mistreatment). | Once at week 15 | 
| Change in caregiver responses to dementia-related behaviors | Experimental (immediate) and control (delayed intervention). Measured using yes/no responses to 8 items (2 from the Conflicts Tactics Scale Revised, 2 from the Conflicts Tactics Scale modified for Older Adults, and 4 from the Conflict Tactics Scale for Child Mistreatment). | Once at week 37 | 
| Change in caregiver responses to dementia-related behaviors | Experimental (immediate) and control (delayed intervention). Measured using yes/no responses to 8 items (2 from the Conflicts Tactics Scale Revised, 2 from the Conflicts Tactics Scale modified for Older Adults, and 4 from the Conflict Tactics Scale for Child Mistreatment). | Once at week 49 | 
| Change in caregiver self-efficacy coping skills | Experimental (immediate) and control (delayed intervention). Measured using 14 items from the Brief Coping Scale. | Immediately after enrollment | 
| Change in caregiver self-efficacy coping skills | Experimental (immediate) and control (delayed intervention). Measured using 14 items from the Brief Coping Scale. | Once at week 15 | 
| Change in caregiver self-efficacy coping skills | Experimental (immediate) and control (delayed intervention). Measured using 14 items from the Brief Coping Scale. | Once at week 37 | 
| Change in caregiver self-efficacy coping skills | Experimental (immediate) and control (delayed intervention). Measured using 14 items from the Brief Coping Scale. | Once at week 49 | 
| Change in caregiver self-efficacy measured by selection of items from 10-item CurB-CuRB-IT Strategy checklist | Experimental (immediate) | Once at week 15 | 
| Change in caregiver self-efficacy measured by selection of items from 10-item CurB-CuRB-IT Strategy checklist | Experimental (immediate) | Once at week 37 | 
| Change in caregiver self-efficacy measured by selection of items from 10-item CurB-CuRB-IT Strategy checklist | Experimental (immediate) | Once at week 49 | 
| Change in caregiver self-efficacy measured by selection of items from 10-item CurB-CuRB-IT Strategy checklist | Control (delayed) | Once at week 37 | 
| Change in caregiver self-efficacy measured by selection of items from 10-item CurB-CuRB-IT Strategy checklist | Control (delayed) | Once at week 49 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dementia, care-resistant behavior, caregiver coping