Coaching Dementia Caregivers to Master Care-Resistant Behavior

Dementia Clinical Trial

— CuRB-IT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05098652
• Other study ID #: IRB-300007452
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: September 30, 2027

Study information

• Verified date: April 2024
• Source: University of Alabama at Birmingham
• Contact: Rita A Jablonski, PhD
• Phone: 205-975-9019
• Email: rajablon[@]uab.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 266
• Est. completion date: September 30, 2027
• Est. primary completion date: August 31, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• Care-resistant Behavior
• Dementia

Intervention

Behavioral:
• CuRB-IT
9 1-hour coaching sessions delivered over a videoconferencing platform (Zoom); 6 delivered weekly, 3 delivered biweekly

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Change in caregiver self-efficacy measured by selection of items from 10-item CurB-CuRB-IT Strategy checklist	Experimental (immediate)	Once at week 15
Primary	Change in caregiver self-efficacy measured by selection of items from 10-item CurB-CuRB-IT Strategy checklist	Experimental (immediate)	Once at week 37
Primary	Change in caregiver self-efficacy measured by selection of items from 10-item CurB-CuRB-IT Strategy checklist	Experimental (immediate)	Once at week 49
Primary	Change in caregiver self-efficacy measured by selection of items from 10-item CurB-CuRB-IT Strategy checklist	Control (delayed)	Once at week 37
Primary	Change in caregiver self-efficacy measured by selection of items from 10-item CurB-CuRB-IT Strategy checklist	Control (delayed)	Once at week 49