Coaching Dementia Caregivers to Master Care-Resistant Behavior (CuRB-IT)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Dementia; Care-resistant Behavior
• Intervention / Treatment: Behavioral: CuRB-IT

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 Type: Interventional
• Enrollment (Estimated): 266
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35244
      • University of Alabama at Birmingham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Immediate Intervention; 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; 9 1-hour coaching sessions delivered over a videoconferencing platform (Zoom); 6 delivered weekly, 3 delivered biweekly
Active Comparator: Delayed intervention; 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; 9 1-hour coaching sessions delivered over a videoconferencing platform (Zoom); 6 delivered weekly, 3 delivered biweekly

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Rita A Jablonski, PhD, University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2023
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): May 31, 2027

Study Registration Dates

• First Submitted: August 17, 2021
• First Submitted That Met QC Criteria: October 18, 2021
• First Posted (Actual): October 28, 2021

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: dementia; care-resistant behavior; caregiver coping
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Dementia
• Other Study ID Numbers: IRB-300007452; R01AG074255 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All research data produced by this project will be self-archived at the University of Michigan's NIA-funded National Archive of Computerized Data on Aging. The storage of our research product here will permit many researchers free access to our data in perpetuity. Our archived study will principally include our original (but anonymized) databases as well as any "cleaned," computed, and recoded measures that we produce for or is produced by our analysis. Our project deliverables will include the quantitative databases, a well-documented statistical packaging (SPSS) system file with variable and values labels, a data user guide that includes all SPSS and related computational and analysis syntax code, summary statistics (frequency distributions, means, etc.) for all quantitative variables, a copy of applicable subject consent form, human subject application and the institutional review board (IRB) approval letter, and a blank copy of the survey instrument and interviewer guide.
• IPD Sharing Time Frame: 6 months after conclusion of study; in perpetuity
• IPD Sharing Access Criteria: 1) a commitment only to use the data for research purposes and not to identify any individual participant; 2) a commitment to securing the data using appropriate computer technology; and 3) a commitment to destroy or return the data after analyses are completed.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No