Open Pilot Trial of a Dyadic Mind-body Program for Cardiac Arrest Survivors and Their Caregivers: Recovering Together After Cardiac Arrest
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Recruitment Feasibility Assessed by the Number of Eligible Dyads Enrolled
研究概览
简要总结
The purpose of this study is to pilot a mind-body intervention for cardiac arrest survivors and their informal caregivers, Recovering Together after Cardiac Arrest. The data the investigators gather in this study will be used to further refine our intervention.
详细描述
The goal of this study is to refine our proposed intervention Recovering Together after Cardiac Arrest (RT-CA) through an open pilot. The investigators will deliver an open pilot of the intervention (N=5 dyads; 10 participants total) to evaluate initial feasibility and acceptability using exit interviews and pre-post assessments.
The open pilot will take place at Massachusetts General Hospital intensive care units and step-down units. Study clinicians will deliver 6, 30 minute sessions of the intervention (at bedside or on Zoom/telephone, depending on participant preference and access). All participants will complete measures at baseline, and after completion of program (6 weeks). At the completion of the program, participants will engage in an exit interview where they will provide feedback of the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •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)
- •Score ≥4 on Short Form of the Mini Mental State Exam
- •Ability and willingness to participate in a hybrid in-person/live video or phone intervention
- •English speaking adults, 18 years or older
- •At least one member of the dyad endorses clinically significant emotional distress during screening (>7 on Hospital Anxiety and Depression Scale subscales)
排除标准
- •1. Active psychosis, mania, substance dependence, or suicidal intent or plan
结局指标
主要结局
Recruitment Feasibility Assessed by the Number of Eligible Dyads Enrolled
时间窗: 0 weeks
Proportion of eligible CA survivor-caregiver dyads that enroll in the intervention amongst those who screen in to the study.
Assessment Feasibility Assessed by the Number of Participants With no Measures Missing on All Self-report Questionnaires.
时间窗: Pre-test (0 weeks) to post-test (6 weeks)
Assessment feasibility was assessed by the number of individual participants (not dyads) that have no measures missing on all self-report questionnaires.
Adherence Feasibility Assessed by the Number of CA Survivor-caregiver Dyads Who Begin the Intervention and Complete at Least 4 of 6 Intervention Sessions.
时间窗: Pre-test (0 weeks) to post-test (6 weeks)
Adherence feasibility was assessed by the number of CA survivor-caregiver dyads who begin the intervention and adhere to it by completing at least 4 of 6 intervention sessions.
Therapist Fidelity Assessed by the Proportion of 9 Randomly Selected Sessions in Which the Study Clinician Delivered Fully Delivered All Key Session Content.
时间窗: Pre-test (0 weeks) to post-test (6 weeks)
Number of sessions in which the therapist adhered 100% to the treatment manual. The study coordinator listened to 9 random RT-CA sessions, and, using a checklist, identified whether the study clinician fully adhered to the content of each session by delivering each key ingredient of the session.
Number of Participants With Client Satisfaction Score Greater Than the Midpoint (7.5).
时间窗: Post-test (6 weeks)
The proportion of participants that scored above the midpoint on the Client Satisfaction Questionnaire-3 (CSQ-3), which assesses satisfaction with a program. Total scores range from 3-12 (midpoint 7.5); higher scores indicate greater satisfaction.
Credibility and Expectancy Assessed by the Number of Individuals That Score Above the Midpoint on Each Sub-scale of the Credibility and Expectancy Questionnaire
时间窗: Pre-test (0 weeks)
Number of individuals that score above the midpoint on each sub-scale of the Credibility and Expectancy Questionnaire (CEQ). Through two subscales, the CEQ assesses participants' perceptions that a program is logical (credible) and their expectancy that participation would lead to improvements (expectancy). Scores on the credibility subscale range from 3-27 (midpoint 15) and scores on the expectancy factor range from 3-31 (midpoint 17); higher scores on each indicate greater credibility and expectancy.
次要结局
- Mean Change in Meaning in Life Questionnaire Sub Scales(Pre-test (0 weeks), Post-Test (6 weeks))
- Mean Change in the Hospital Depression and Anxiety Scale Total Score.(Pre-test (0 weeks), Post-Test (6 weeks))
- Mean Change in Post-Traumatic Stress Disorder Checklist - 5 Total Score.(Pre-test (0 weeks), Post-Test (6 weeks))
- Mean Change in The Cognitive and Affective Mindfulness Scale-Revised Total Score(Pre-test (0 weeks), Post-Test (6 weeks))
- Mean Change in Enhancing Recovery in Coronary Heart Disease Social Support Inventory Total Score(Pre-test (0 weeks), Post-Test (6 weeks))
- Mean Change in Measure of Current Status Part A (MOCS-A) Average Score.(Pre-test (0 weeks), Post-Test (6 weeks))
- Mean Change in the World Health Organization Quality of Life-Brief Sub Scale Scores(Pre-test (0 weeks), Post-Test (6 weeks))
- Mean Change in Dyadic Relationship Scale Sub Scales(Pre-test (0 weeks), Post-Test (6 weeks))
- Mean Change in Dyadic Coping Inventory Sub Scales(Pre-test (0 weeks), Post-Test (6 weeks))
- Mean Change in Applied Mindfulness Scale Total Score.(Pre-test (0 weeks), Post-Test (6 weeks))
- Mean Change in Preparedness for Caregiving Scale Total Score(Pre-test (0 weeks), Post-Test (6 weeks))
- Gratitude Questionnaire Six Item Form(Pre-test (0 weeks), Post-Test (6 weeks))
研究者
Alexander Presciutti
Principal Investigator
Massachusetts General Hospital