Development of a Dyadic Mind-body Program for Cardiac Arrest Survivors and Their Caregivers: Recovering Together After Cardiac Arrest (RT-CA).
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- Credibility (RT-CA 1)
研究概览
简要总结
The purpose of this study is to pilot two resilience interventions for cardiac arrest survivors and their informal caregivers, Recovering Together after Cardiac Arrest 1 and Recovering Together after Cardiac Arrest 2 . The data the investigators gather in this study will be used to further refine the interventions.
详细描述
The goal of this study is to test the feasibility of our proposed interventions through a pilot RCT. The investigators will deliver the RCT intervention (N=42 dyads; 84 participants total) and evaluate feasibility and acceptability based on a priori benchmarks.
The RCT will initially take place at Massachusetts General Hospital intensive care units and step-down units. Cardiac arrest survivor-caregiver dyads will be randomly assigned to one of two groups - Recovering Together after Cardiac Arrest 1 (RT-CA 1) or Recovering Together after Cardiac Arrest 2 (RT-CA 2).
RT-CA 1 involves six, 30-minute weekly sessions beginning at bedside and continuing over Zoom after the survivor is discharged. RT-CA 2 involves one, 30 minute session at bedside.
All participants will complete psychosocial survey measures at baseline, six weeks, and 3 months.
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
- Single (Participant)
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
- •Out-of-hospital or in-hospital CA survivor (must have new diagnosis of "cardiac arrest" in electronic medical record from index hospitalization with documented loss of pulse) with an identified caregiver (identified by the survivor who is their primary source of emotional and functional support)
- •survivor must score >5 on Short Form of the Mini Mental State Exam for sufficient cognitive function for meaningful participation
- •ability and willingness to participate in a hybrid in-person/live video intervention
- •English speaking adults (18 year or older)
- •at least one member of the dyad endorses clinically significant emotional distress during screening (>7 on either of the Hospital Anxiety and Depression Scale subscales).
排除标准
- •active psychosis, mania, substance dependence, or suicidal intent or plan that would require a higher level of care
- •any other psychiatric or neurological condition that would preclude meaningful participation
- •the caregiver must not be a cardiac arrest survivor
结局指标
主要结局
Credibility (RT-CA 1)
时间窗: pre-test
Proportion of RT-CA 1 participants that endorse program credibility at pre-test, defined as scoring above the midpoint on the Credibility sub scale of the Credibility/Expectancy Questionnaire
Expectancy (RT-CA 1)
时间窗: pre-test
Proportion of RT-CA 1 participants that endorse expectancy to improve. from the program at pre-test, defined as scoring above the midpoint on the Expectancy sub scale of the Credibility/Expectancy Questionnaire
Study safety
时间窗: at the end of treatment at 6 weeks and 3 months after the end of treatment
The proportion of participants that report no adverse events related to study participation.
Feasibility of Recruitment
时间窗: pre-test
Proportion of eligible dyads that consent to participation
Feasibility of Randomization
时间窗: The end of treatment at 6 weeks
Proportion of randomized participants who submit post-test assessments
Feasibility of Assessment Completion
时间窗: pre-test, the end of treatment at 6 weeks, and 3 months after the end of treatment
Proportion of participants with no assessment measures missing at pre-test, post-test, and 3 month follow-up
Feasibility of Program Adherence (RT-CA 1)
时间窗: the end of treatment at 6 weeks
Proportion of RT-CA 1 dyads that initiate the program by attending session 1 and complete at least 4 of 6 sessions.
Therapist Fidelity
时间窗: the end of treatment at 6 weeks
Proportion of 20% randomly-selected RT-CA 1 sessions in which the therapist fully adheres to program content, ascertained by a fidelity checklist
Treatment Satisfaction (RT-CA 1)
时间窗: the end of treatment at 6 weeks
Proportion of RT-CA 1 participants that endorse satisfaction, defined as above the midpoint on the Client Satisfaction Questionnaire-3
次要结局
未报告次要终点
研究者
Alexander Presciutti
Member of the Faculty
Massachusetts General Hospital