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

The University of Alabama at Birmingham

Status: Active, not recruiting

Conditions: Care-resistant Behavior; Dementia

Treatments: Behavioral: CuRB-IT

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05098652

IRB-300007452

R01AG074255 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 266 estimated patients

Sex: All

Ages: 18 to 95 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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266 participants in 2 patient groups

Immediate Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: CuRB-IT

Delayed intervention

Active Comparator group

Description:

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.

Treatment:

Behavioral: CuRB-IT