Coaching Dementia Caregivers to Master Care-Resistant Behavior and Improve Coping Strategies
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 266
- 试验地点
- 2
- 主要终点
- Change in caregiver responses to dementia-related behaviors
研究概览
简要总结
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.
详细描述
The purposes of the delayed-intervention randomized clinical trial (N=266) are to:
Care-Resistant Behavior Internet Training (CuRB-IT).
- 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);
- 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;
- examine intervention decay at 3- and 6-months post intervention to determine performance of intervention and inform scheduling of booster sessions;
- assess the efficacy of the CuRB-IT intervention in preventing onset of poor coping strategies by family caregivers;
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •1) persons who cannot speak/read English
- •2) who do not have reliable access to a smart phone or internet
研究组 & 干预措施
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.
干预措施: CuRB-IT (Behavioral)
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.
干预措施: CuRB-IT (Behavioral)
结局指标
主要结局
Change in caregiver responses to dementia-related behaviors
时间窗: Once at week 49
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).
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
时间窗: Daily during weeks 49, 50, and 51
Experimental and control
Change in caregiver self-efficacy coping skills
时间窗: Once at week 49
Experimental (immediate) and control (delayed intervention). Measured using 14 items from the Brief Coping Scale.
Change in caregiver self-efficacy measured by selection of items from 10-item CurB-CuRB-IT Strategy checklist
时间窗: Once at week 49
Experimental (immediate)
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
时间窗: Daily during weeks 1, 2, and 3
Experimental and control
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
时间窗: Daily during weeks 15, 16, and 17
Experimental and control
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
时间窗: Daily during weeks 37, 38, and 39
Experimental and control
Change in caregiver responses to dementia-related behaviors
时间窗: Immediately after enrollment
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).
Change in caregiver responses to dementia-related behaviors
时间窗: Once at week 15
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).
Change in caregiver responses to dementia-related behaviors
时间窗: Once at week 37
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).
Change in caregiver self-efficacy coping skills
时间窗: Immediately after enrollment
Experimental (immediate) and control (delayed intervention). Measured using 14 items from the Brief Coping Scale.
Change in caregiver self-efficacy coping skills
时间窗: Once at week 15
Experimental (immediate) and control (delayed intervention). Measured using 14 items from the Brief Coping Scale.
Change in caregiver self-efficacy coping skills
时间窗: Once at week 37
Experimental (immediate) and control (delayed intervention). Measured using 14 items from the Brief Coping Scale.
Change in caregiver self-efficacy measured by selection of items from 10-item CurB-CuRB-IT Strategy checklist
时间窗: Once at week 15
Experimental (immediate)
Change in caregiver self-efficacy measured by selection of items from 10-item CurB-CuRB-IT Strategy checklist
时间窗: Once at week 37
Experimental (immediate)
次要结局
未报告次要终点
研究者
Rita A. Jablonski
Professsor
University of Alabama at Birmingham