NCT07630844尚未招募不适用
A Randomized Trial of REFRAME: an Emotion Regulation Intervention to Improve Psychological Outcomes in Surrogate Decision-Makers of the Critically Ill
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 387
- 试验地点
- 1
研究概览
简要总结
Every year in the United States, millions of adults make crucial medical decisions for loved ones in the intensive care unit while facing extreme emotional stress. This project will assess REFRAME, a brief tablet-based program designed to help decision-makers manage their emotions in these situations. Results from this study may lead to the creation of a widely accessible tool that alleviates emotional suffering and enhances the quality of medical decision-making for families in crisis.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient Inclusion Criteria:
- •1. Age ≥ 35 years
- •2. Lacks decision-making capacity
- •3. Not expected to be discharged from the ICU in 24 hours (including death)
- •Legally Authorized Representative Inclusion Criteria (Primary Participant)
- •1. Age ≥ 18 years
- •2. Identified as LAR by ICU team
- •3. Able to speak and understand English
- •4. Able to visualize content on a tablet device
排除标准
- •1. Age < 35 years
- •2. Possesses decision-making capacity
- •3. Anticipated discharge from ICU within next 24 hours.
- •Legally Authorized Representative Exclusion Criteria:
- •1. Age < 18 years
- •2. Not recognized as LAR by ICU team
- •3. Unable to speak and understand English
- •4. Unable to visualize content on a tablet device
研究组 & 干预措施
REFRAME
Experimental
Tablet-Based Emotion Regulation Tool
干预措施: REFRAME (Behavioral)
Informational Support
Other
Video-Based Psychoeducational Attention Control
干预措施: Informational Support (Behavioral)
研究者
Grant Pignatiello
Assistant Professor
Case Western Reserve University
研究点 (1)
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