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Clinical Trials/NCT05098652
NCT05098652
Recruiting
Not Applicable

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

University of Alabama at Birmingham1 site in 1 country266 target enrollmentApril 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Care-resistant Behavior
Sponsor
University of Alabama at Birmingham
Enrollment
266
Locations
1
Primary Endpoint
Change in caregiver self-efficacy measured by selection of items from 10-item CurB-CuRB-IT Strategy checklist
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2023
End Date
September 30, 2027
Last Updated
last year
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Rita A. Jablonski

Professor

University of Alabama at Birmingham

Eligibility Criteria

Inclusion Criteria

  • Caregiver of any race or gender who is aged \>18 years
  • provides unpaid care,
  • cares for a spouse/common-law, sibling, parent or grandparent (or in-law, aged 60+ years),
  • lives with or shares cooking facilities with the care recipient,
  • Care recipient has mild cognitive impairment or dementia as identified using the Quick Dementia Rating System instrument,
  • the care provided consists of help with at least 2 Instrumental Activities of Daily Living or one Activity of Daily Living,
  • the care recipient is resistant to receiving assistance with, or refuses to do, at least one instrumental or activity of daily living

Exclusion Criteria

  • persons who cannot speak/read English
  • who do not have reliable access to a smart phone or internet

Outcomes

Primary Outcomes

Change in caregiver self-efficacy measured by selection of items from 10-item CurB-CuRB-IT Strategy checklist

Time Frame: Once at week 49

Control (delayed)

Change in caregiver responses to dementia-related behaviors

Time Frame: 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

Time Frame: Daily during weeks 49, 50, and 51

Experimental and control

Change in caregiver self-efficacy coping skills

Time Frame: Once at week 49

Experimental (immediate) and control (delayed intervention). Measured using 14 items from the Brief Coping Scale.

Study Sites (1)

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