The Residential Care Transition Module
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- Change in care-related strain
研究概览
简要总结
Emerging research on family caregiving and institutionalization has emphasized that families do not disengage from care responsibilities following a relative's admission to residential long-term care settings. The Residential Care Transition Module (RCTM) provides 6 formal sessions of consultation (one-to-one and family sessions) over a 4-month period to those family caregivers who have admitted a cognitively impaired relative to a residential long-term care setting (nursing home, assisted living memory care unit). The proposed mixed method, randomized controlled trial will determine whether and how the RCTM decreases family caregivers' emotional and psychological distress, placement-related strain, and increases relative's transitions back to the community. The RCTM will fill an important clinical and research gap by evaluating a psychosocial intervention designed for families following RLTC placement to determine whether and how this approach can help families better navigate the residential care transitions of relatives with Alzheimer's disease or a related dementia.
详细描述
Emerging research on family caregiving and institutionalization has found that families do not disengage from care responsibilities following relatives' admissions to residential long-term care settings. Families instead remain involved in a spectrum of care activities ranging from instrumental activities of daily living to emotional support. Perhaps for these reasons, a number of studies have noted that caregiving stress, depression, or other key outcomes remain stable or sometimes increase following residential long-term care (RLTC) entry for certain types of caregivers. A few interventions have attempted to increase family involvement after institutionalization, but no rigorous studies have demonstrated that these interventions are effective in helping families navigate transitions to RLTC environments.
The Residential Care Transition Module (RCTM) provides 6 formal sessions of consultation (one-to-one and family sessions) over a 4-month period to those family caregivers who have recently admitted a relative to a RLTC setting. In this randomized controlled trial, family members who have admitted a cognitively impaired relative to a RLTC setting will be randomly assigned to the RCTM [(n = 120)] or a usual care control condition [(n = 120)]. A mixed methods analysis will be used to pursue the following aims: Specific Aim 1: Assess whether the RCTM yields statistically significant reductions in family members' primary subjective stress and negative mental health outcomes; Specific Aim 2) Determine whether family members who receive the RCTM will indicate statistically significant decreases in secondary role strains over a 12-month period when compared to usual care controls; Specific Aim 3) Determine whether RCTM family members report statistically significant decreases in residential care stress when compared to family members in the usual care control group; and Specific Aim 4) Delineate the mechanism of action of RCTM under conditions of high and low success by "embedding" qualitative components (30 semi-structured interviews) at the conclusion of the 12-month evaluation.
The proposed project will fill an important clinical and research gap by evaluating a psychosocial intervention designed for families following RLTC placement that determines whether and how the RCTM can help families better navigate the residential care transitions of cognitively impaired relatives.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Family caregivers of relatives who have received a physician's diagnosis of Alzheimer's disease or a related dementia (ADRD)
- •Family caregivers who consider themselves the most involved in visiting and providing assistance to a relative experiencing a long-stay admission to an assisted living, nursing home, memory care, or other residential long-term care setting. Those who share the primary caregiving role equally are also eligible.
- •Family caregivers must be English speaking, 21 years of age or older
- •Family caregivers on psychotropic medications, such as anti-depressants or anti-psychotics, will be eligible if they have remained on a stable dosage for the last 3 months
排除标准
- •Family caregivers who are participating in any other type of service that provides one-to-one psychosocial consultation specifically for caregiving (support group participation is not a deterrent to enrollment, nor is general counseling not specific to caregiving)
结局指标
主要结局
Change in care-related strain
时间窗: 12 months
A 7-item measure of care-related strain that assesses the stress family caregivers perceive as a result of having a relative in residential care
Change in burden: Zarit Burden Interview
时间窗: 12 months
A 7-item version of the Zarit Burden Interview
Change in stress: Perceived Stress Scale
时间窗: 12 months
The Perceived Stress Scale
次要结局
- Quantitative measure of resilience to negative psychosocial effects of COVID-19(0, 1 and 4 months post-pandemic onset)
- Qualitative measure of resilience to negative psychosocial effects of COVID-19(0, 1 and 4 months post-pandemic onset)
