Pilot Evaluation of FAMCOPE-ICU
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 2
- 主要终点
- Acceptability of Intervention Measure
研究概览
简要总结
Having a family member or loved one in the ICU can be a very stressful experience. The investigators have created a tablet-based tool (FAMCOPE-ICU) that is designed to help people in this position cope with this experience.
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
- None
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient Inclusion Criteria:
- •18-89 years old
- •Intensive Care Unit (ICU) length of stay (LOS) >= 48 hours
- •No anticipated ICU LOS for next 24 hours
- •Unable to make healthcare decisions
- •Family Inclusion Criteria
- •Identified by critical care team as legally authorized representative (LAR)
- •Able to speak or comprehend English
- •>= 18 years old
排除标准
- •Less than 18 years or older than 89 years
- •ICU LOS < 48 hours
- •Anticipated ICU discharge within next 24 hours
- •Able to make healthcare decisions
- •Family Exclusion Criteria
- •Not identified by critical care team as the LAR
- •Unable to speak or comprehend English
- •< 18 years old
研究组 & 干预措施
FAMCOPE-ICU
A digital eHealth emotion regulation and coping intervention.
干预措施: FAMCOPE-ICU (Behavioral)
Usual Care
The care and support routinely provided to SDMs of critically ill patients.
结局指标
主要结局
Acceptability of Intervention Measure
时间窗: After dose 3, 5 minutes
Four item self-report survey; item responses range from 1 (completely disagree) to 5 (completely agree)
Acceptability of Intervention Measure
时间窗: After dose 1, 5 minutes
Four item self-report survey; item responses range from 1 (completely disagree) to 5 (completely agree)
Acceptability of Intervention Measure
时间窗: After dose 2, 5 minutes
Four item self-report survey; item responses range from 1 (completely disagree) to 5 (completely agree)
次要结局
- Change in Anxiety as Measured by PROMIS Anxiety Short Form(Baseline (enrollment), one week.)
- Change in Depression as Measured by PROMIS Depression Short Form(Baseline (enrollment), one week.)
- Sleep Disturbance as Measured by PROMIS Sleep Disturbance Short Form(Baseline (enrollment))
- Decision Fatigue Scale(One week post-enrollment)
- Decisional Conflict Scale(One week post-enrollment)
- Satisfaction as Measured by the Family Satisfaction in the Intensive Care Unit Scale - 24R(One week post-enrollment)
研究者
Grant Pignatiello
Instructor and NCATS Clinical Research KL2 Scholar
University Hospitals Cleveland Medical Center