Ignite Creation Date:
2024-05-06 @ 4:48 PM
Last Modification Date:
2024-10-26 @ 2:16 PM
Study NCT ID:
NCT05098652
Status:
RECRUITING
Last Update Posted:
2024-04-16
First Post:
2021-08-17
Brief Title:
Coaching Dementia Caregivers to Master Care-Resistant Behavior
Sponsor:
University of Alabama at Birmingham
Organization:
University of Alabama at Birmingham
Study Overview
Official Title:
Coaching Dementia Caregivers to Master Care-Resistant Behavior and Improve Coping Strategies
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CuRB-IT
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 N266 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None