Self-Management Interventions: Considering Needs & Preferences of Dementia Caregivers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 328
- 试验地点
- 2
- 主要终点
- Change in Caregiver Global Health - Mental Health: PROMIS (Patient Reported Outcomes Measurement Information System)
研究概览
简要总结
How do varying levels of participation in selecting self-management interventions (ranging from no input into the selection to selection based on need or preference) affect health risks and physical and mental health over time in family caregivers of persons with Alzheimer's and other dementia disorders? Caregivers will be randomized to 1) information on diversional activities (attention control); 2) self-management intervention based on need (SM-need); or 3) self-management intervention of their preference (SM-preference).
详细描述
The study has two aims: The primary aim (A1) is to examine differences across the three groups (attention control, SM-need, and SM-preference) on caregiver health (health risks and mental and physical health) over time. The investigators hypothesize that the caregivers who receive a self-management intervention based on need (SM-need) or preference (SM-preference) will have better health outcomes than those in the attention control.
Secondary aims are to: A2) explore whether caregiver baseline need or preference for intervention (i.e. choice) is associated with: a) care recipient's symptoms; b) caregiver reactions; and c) caregiving involvement, and A3) build caregiver profiles from demographic/ contextual factors that are associated with their needs and preferences for the self-management interventions.
All caregivers will complete assessment measures and measures of health risks, and physical and mental health at baseline (T1), about 6 months (T2), and about 12 months (T3). Caregivers will be randomly assigned to one of three groups. The attention control group will receive information on diversional activities. The SM-need group will receive a self-management intervention for biofeedback training or resourcefulness training, as determined by baseline cut scores. Caregivers in the SM-preference group will choose one of the two self-management interventions according to their personal preference.
Both self-management interventions (biofeedback training, resourcefulness training) and the diversional activities, are delivered over four weeks (between T1 and T2). Caregivers may use the intervention whenever and as often as they wish (i.e. self-tailoring) for the remainder of the study period. These resourcefulness training includes teaching self-help (stress-management, problem-solving) and help-seeking skills, respectively. Biofeedback training consists of the use of a hand-held device that shows the participant their changes in heart rate based on changes in their breathing pattern (as they relax); caregivers who need or prefer the biofeedback will be given a device to use for 28 days. All study participants receiving the intervention will also be asked to keep a journal to record their experience with the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Participants were aware of which intervention they were receiving (Resourcefulness Training, HRV-focused BioFeedback, Attention Control: Diversonal Activities, but were not aware of which arm they had been randomly assigned to, or whether their intervention was an active or placebo comparator. The PI and Outcomes Assessor were blinded as to the identity of individual participants, and, during data collection, which participants had been assigned to which arm/intervention. In order to complete study aims, variables indicating arm and intervention assignment were included in the final data file.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •At least 18 years old
- •Have a living family member or a recently deceased family member diagnosed with Alzheimer's disease or another dementia
- •Identify self as a primary caregiver
- •In-home Caregivers: must be currently providing a minimum of 4 hours per day of supervision/direct care, and have entered that role within the past twelve months; Care Partners whose family member moved into a nursing or assisted living facility within the past twelve months, and must report visiting their care recipient at least once per week; Caretakers (i.e. bereaved) whose family member is deceased within the past twelve months, and are persons with direct oversight of the deceased person's belongings, estate, finances, etc.
- •Be capable of performing informed consent and participating in study procedures
排除标准
- •Does not have a family member with Alzheimer's disease or another dementia
- •Has not cared for a living family member with dementia within the last 12 months, or the family member has been deceased for more than 12 months
- •Has knowledge of another family member in the same household enrolled in the study
- •Currently pregnant
- •Has a pacemaker
- •Lives outside of the study area
结局指标
主要结局
Change in Caregiver Global Health - Mental Health: PROMIS (Patient Reported Outcomes Measurement Information System)
时间窗: From T1 (baseline) to T2 (6 months) through T3 (one year)
Change in self-assessment of general mental health, as measured by the Patient-Reported Outcomes Measurement Information System 10-Question Short Form (PROMIS-10 Global Health). Ten items are rated on a five-point scale, scores range from 0-20, and a higher score indicates better health and health-related quality of life.
Change in Caregiver's Health Risk Behavior Scale
时间窗: From T1 (baseline) to T2 (6 months) through T3 (one year)
Measure of Caregiving Health Risks: 9 items; 3-point scale, Scores range 9-27; higher score indicates greater risk
Change in Caregiver's Perceived Stress Scale
时间窗: From T1 (baseline) to T2 (6 months) through T3 (one year)
14 items; 3-point scale; Scores range 9-27; higher score indicates greater perceived stress
Change in Caregiver's Negative Emotions Checklist
时间窗: From T1 (baseline) to T2 (6 months) through T3 (one year)
10 items; dichotomous list; Scores range 0-10; higher score indicates more negative emotions.
Change in Caregiver's Depressive Cognitions Scales
时间窗: From T1 (baseline) to T2 (6 months) through T3 (one year)
8 items; 6-point scale; Scores range 0-40; higher score indicates higher depressive cognition
Change in Global Health - Physical Health: PROMIS (Patient Reported Outcomes Measurement Information System)
时间窗: From T1 (baseline) to T2 (6 months) through T3 (one year)
Change in self-assessment of general physical health, as measured by the Patient-Reported Outcomes Measurement Information System 10-Question Short Form (PROMIS-10 Global Health). Ten items are rated on a five-point scale, scores range from 0-20, and a higher score indicates better health and health-related quality of life.
次要结局
未报告次要终点
研究者
Jaclene A. Zauszniewski
Principal Investigator
Case Western Reserve University