Coaching Dementia Caregivers to Master Care-Resistant Behavior

Not Applicable

Recruiting

• Conditions: Dementia; Care-resistant Behavior
• Interventions: Behavioral: CuRB-IT

• Registration Number: NCT05098652
• Lead Sponsor: University of Alabama at Birmingham

Brief Summary

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

The purposes of the delayed-intervention randomized clinical trial (N=266) are to:

Care-Resistant Behavior Internet Training (CuRB-IT).

1. 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);

2. 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;

3. examine intervention decay at 3- and 6-months post intervention to determine performance of intervention and inform scheduling of booster sessions;

4. assess the efficacy of the CuRB-IT intervention in preventing onset of poor coping strategies by family caregivers;

5. 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.

Study Timeline

• Study First Submitted: 2021-08-17
• Study First Submitted QC: 2021-10-18
• Study First Posted: 2021-10-28
• Study Start: 2023-04-01
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-22
• Last Update Posted: 2025-04-25
• Primary Completion: 2027-08-31
• Study Completion: 2027-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 266

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, sibling, 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Immediate Intervention	CuRB-IT	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.
Delayed intervention	CuRB-IT	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.

Primary Outcome Measures

Name	Time	Method
Change in caregiver self-efficacy measured by selection of items from 10-item CurB-CuRB-IT Strategy checklist	Once at week 49	Control (delayed)
Change in caregiver responses to dementia-related behaviors	Once at week 49	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).
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	Daily during weeks 49, 50, and 51	Experimental and control
Change in caregiver self-efficacy coping skills	Once at week 49	Experimental (immediate) and control (delayed intervention). Measured using 14 items from the Brief Coping Scale.

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States