Clinical trial NCT05098652: Coaching Dementia Caregivers to Master Care-Resistant Behavior
Official title: Coaching Dementia Caregivers to Master Care-Resistant Behavior and Improve Coping Strategies
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Care-resistant Behavior
Dementia
Keywords: dementia
care-resistant behavior
caregiver coping
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2021-10-28
Enrollment: 266
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 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
timeFrame: Daily during weeks 1, 2, and 3
measure: 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
timeFrame: Daily during weeks 15, 16, and 17
measure: 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
timeFrame: Daily during weeks 37, 38, and 39
measure: 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
timeFrame: Daily during weeks 49, 50, and 51
measure: Change in caregiver responses to dementia-related behaviors
timeFrame: Immediately after enrollment
measure: Change in caregiver responses to dementia-related behaviors
timeFrame: Once at week 15
measure: Change in caregiver responses to dementia-related behaviors
timeFrame: Once at week 37
measure: Change in caregiver responses to dementia-related behaviors
timeFrame: Once at week 49
measure: Change in caregiver self-efficacy coping skills
timeFrame: Immediately after enrollment
measure: Change in caregiver self-efficacy coping skills
timeFrame: Once at week 15
measure: Change in caregiver self-efficacy coping skills
timeFrame: Once at week 37
measure: Change in caregiver self-efficacy coping skills
timeFrame: Once at week 49
measure: Change in caregiver self-efficacy measured by selection of items from 10-item CurB-CuRB-IT Strategy checklist
timeFrame: Once at week 15
measure: Change in caregiver self-efficacy measured by selection of items from 10-item CurB-CuRB-IT Strategy checklist
timeFrame: Once at week 37
measure: Change in caregiver self-efficacy measured by selection of items from 10-item CurB-CuRB-IT Strategy checklist
timeFrame: Once at week 49
measure: Change in caregiver self-efficacy measured by selection of items from 10-item CurB-CuRB-IT Strategy checklist
timeFrame: Once at week 37
measure: Change in caregiver self-efficacy measured by selection of items from 10-item CurB-CuRB-IT Strategy checklist
timeFrame: Once at week 49
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Rita A Jablonski, PhD
role: PRINCIPAL_INVESTIGATOR
References: