Building Resilience in Skilled Nursing Care: A Behavioral Health Intervention for Residents & Care Partners
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Treatment Credibility
研究概览
简要总结
The goal of this clinical trial is to test a behavioral health program (Interventions for Stressful Transitions in Later Life, InSTILL) for skilled nursing facility residents and their primary support person. The main questions it aims to answer is whether the program is program is feasible, satisfactory, and helpful. The researchers will compare the InSTILL program to minimally enhanced usual care. Participants will be randomly assigned to receive either the InSTILL program or minimally enhanced usual care. Participants will complete assessments at three timepoints (all) and a brief-exit interview.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient and care partner both aged ≥ 18 years
- •Patient with care partner (known person providing regular health-related, socioemotional, or practical support) willing to participate
- •Patient reporting depression symptoms on a screening tool (Patient Health Questionnaire)
排除标准
- •Patient intended length of nursing facility stay < 7 days
- •Patient evidencing more than mild impairment on a cognitive screen (Brief Interview for Mental Status)
- •Patient's roommate in skilled nursing facility already enrolled in study/intervention
- •Either patient or care partner reporting high risk of suicidality, based on a standardized safety assessment tool
- •Either patient or care partner participating in newly initiated psychotherapy
结局指标
主要结局
Treatment Credibility
时间窗: peri-intervention
3-item self-report measure of participant's belief regarding how helpful the intervention will be for them. Higher scores (min = 0, max = 30) scores indicate greater credibility.
Client Satisfaction Questionnaire
时间窗: immediately after the intervention
3-item self-report measure assessing patient satisfaction with the program. Higher total scores (min = 3, max = 12) indicate greater satisfaction.
Feasibility of Recruitment
时间窗: baseline, pre-intervention
Percentage of eligible approached dyads that are enrolled into the study.
Feasibility of Data Collection
时间窗: 1 month follow-up
Percentage of all participants with no measure fully missing at follow-up.
Treatment Adherence
时间窗: immediately after the intervention
Percentage of InSTILL participants completing 5/8 sessions
Clinician Fidelity
时间窗: immediately after the intervention
Percentage of InSTILL sessions delivered with 100% adherence on a study-specific Fidelity Checklist.
Adverse Events
时间窗: 1 month follow-up
Any adverse events related to participation in the study.
Treatment Acceptability Survey
时间窗: immediately after the intervention
Percentage of InSTILL participants scoring above the scale midpoint on all 9 Treatment Acceptability Survey items (developed for the current study).
次要结局
- PHQ-9(baseline, pre-intervention; immediately after the intervention; 1 month follow-up)
- Selection, Optimization, and Compensation in Everyday Use(baseline, pre-intervention; immediately after the intervention; 1 month follow-up)
- Committed Action Questionnaire(baseline, pre-intervention; immediately after the intervention; 1 month follow-up)
- Perceptions of Collaboration Questionnaire(baseline, pre-intervention; immediately after the intervention; 1 month follow-up)
- General Anxiety Disorder-7(baseline, pre-intervention; immediately after the intervention; 1 month follow-up)
- Euro QoL-5D 5L(baseline, pre-intervention; immediately after the intervention; 1 month follow-up)
- Relationship Assessment Scale(baseline, pre-intervention; immediately after the intervention; 1 month follow-up)
- Preparedness for Future Care(baseline, pre-intervention; immediately after the intervention; 1 month follow-up)
- COREQ(immediately after the intervention)
- University of Washington Resilience Scale Short Form(baseline, pre-intervention; immediately after the intervention; 1 month follow-up)
- Zarit Burden Interview(baseline, pre-intervention; immediately after the intervention; 1 month follow-up)
- Psychotropic medication use(baseline, pre-intervention; immediately after the intervention; 1 month follow-up)
- Re-hospitalization(immediately after the intervention; 1 month follow-up)
研究者
Evan Plys
Assistant Professor of Psychology
Massachusetts General Hospital