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临床试验/NCT06086301
NCT06086301已完成不适用

Pilot Testing Post-Intensive Care Transitions Using Rehabilitation and Engagement To Heal ICU Survivors and Families (PICTURE-THIS)

University of Pittsburgh2 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2023年8月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
42
试验地点
2
主要终点
Enrollment

研究概览

简要总结

This is a single-center pilot study examining the feasibility and acceptability of a transitional rehabilitation intervention, PICTURE-THIS, among critical illness survivors and their families. The intervention activities include transitional care coordination and activity-based rehabilitation delivered by a specialist team and integrated into usual care. There are three components to the assessment of feasibility and acceptability in this study:

  1. User testing the PICTURE-THIS protocol to work out basic challenges to feasibility and acceptability.
  2. Assessing the feasibility and acceptability of the user-tested PICTURE-THIS protocol.
  3. Assessing the feasibility and acceptability of research activities required to test the clinical efficacy of PICTURE-THIS to improve outcomes among critical illness survivors and their family caregivers.

详细描述

Purpose: PICTURE-THIS is a transitional rehabilitation intervention for critical illness survivors and their family caregivers. It has 2 phases: (1) A Run-In Phase in the hospital; (2) A post-discharge phase. The purpose of this study is to user- and pilot-test the protocols for PICTURE-THIS.

Aim 1: To test, troubleshoot, and revise study procedures and protocols for PICTURE-THIS with a convenience sample of critical illness survivors and their family caregivers.

The investigators will: 1) ensure that dyads reliably adhere to PICTURE-THIS protocols; 2) troubleshoot assessments at enrollment and 3 and 6 month follow-up; 3) refine data collection and management procedures.

Aim 2: To pilot test PICTURE-THIS for feasibility and acceptability among a convenience sample of critical illness survivors and their family caregivers.

Feasibility will be demonstrated by: 1) >80% completion of clinical assessments; 2) >80% retention rate (enrolled patients attending ≥ 2 outpatient transitional care visits and 8 rehabilitation sessions); 2) >80% completion rate for surveys assessing outcomes.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Enrollment

时间窗: Up to 6 months

Achieving an enrollment rate of 80% of eligible participants. Enrollment Rate (%) = (Number of Enrolled Participants / Number of Eligible Participants) x 100

Retention

时间窗: Up to 6 months

Maintaining an active engagement and complete participation rate of 80% throughout the study. Retention Rate (%) = (Number of Retained Participants / Number of Enrolled Participants) x 100

次要结局

  • PROPr(Up to 6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Leslie Scheunemann

Assistant Professor

University of Pittsburgh

研究点 (2)

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