Coaching Dementia Caregivers to Master Care-Resistant Behavior

NCT ID: NCT05098652

Last Updated: 2025-04-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 266 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-01
• Study Completion Date: 2027-09-30

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.

Conditions

Care-resistant Behavior; Dementia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

CuRB-IT

Intervention Type: BEHAVIORAL

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

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.

Group Type: ACTIVE_COMPARATOR

CuRB-IT

Intervention Type: BEHAVIORAL

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

Interventions

CuRB-IT

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Rita A. Jablonski

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rita A Jablonski, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Rita A Jablonski, PhD

Role: CONTACT

rajablon@uab.edu

205-975-9019

Frank Puga, PhD

Role: CONTACT

fpuga@uab.edu

205-975-9423

Facility Contacts

Rita A Jablonski, PhD

Role: primary

rajablon@uab.edu

205-975-9019

Frank Puga, PhD

Role: backup

fpuga@uab.edu

205-9759423

Other Identifiers

IRB-300007452

Identifier Type: -

Identifier Source: org_study_id