NCT06984770尚未招募不适用
Caring for the Caregiver: A Pilot Randomized Controlled Trial (The Family Cares Trial)
Lady Davis Institute2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年8月1日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Caregiver Burden - The Zarit Burden Interview-12 (ZBI-12) - 3 months
研究概览
简要总结
The goal of this pilot study is to learn if virtual peer support groups and strengths-based skills training can help family caregivers of ICU survivors providing ongoing support to ICU survivors after hospital discharge. The main question it aims to answer is:
- Are virtual peer support groups and/or strengths-based skills support feasible and acceptable for family caregivers of ICU survivors? Researchers will compare the intervention group (virtual peer support groups or strengths-based skills training) to the control group (no intervention) to see if the interventions improve caregiver outcomes and assess feasibility and acceptability.
Participants will:
- Participate in either virtual peer support groups or strengths-based skills training sessions (if assigned to the intervention arm).
- Provide feedback on the feasibility and acceptability of the interventions (if assigned to the intervention arm).
- Complete surveys and follow-up questionnaires (either online or by phone) to measure outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Investigator, 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
- 是
入选标准
- •(1) Family member of a person admitted to an ICU for >48 hours and survived to hospital discharge. "Family" is anyone with a biological, legal, or emotional relationship with the patient and whom the patient wants involved in their care
- •(2) Planned or current part or full-time caregiver of the ICU survivor
- •(3) Age ≥ 18 years
- •(4) Within 6 months of ICU survivor's hospital discharge.
排除标准
- •(1) Another family member participating in the study
- •(2) Inability to communicate in English or French.
结局指标
主要结局
Caregiver Burden - The Zarit Burden Interview-12 (ZBI-12) - 3 months
时间窗: 3 months post-enrollment or post intervention initiation
A 12-item self-report tool that has been validated for measuring the level of caregiver burden related to care provision. Each item in the ZBI-12 is scored on a five-point Likert scale from 0 to 4 (0=never to 4=nearly always). Summed scores range from 0-48, with greater scores representing greater feelings of burden.
次要结局
- Insomnia Severity Index (ISI) - 6 months(6 months post-enrollment or post intervention initiation)
- Quality of life (EuroQOL-5D-5L score) - 3 months(3 months post-enrollment or post intervention initiation)
- Caregiver Burden - The Zarit Burden Interview-12 (ZBI-12) - 6 months(6 months post-enrollment or post intervention initiation)
- Multidimensional Scale of Perceived Social Support (MSPSS) - 3 months(3 months post-enrollment or post intervention initiation)
- Multidimensional Scale of Perceived Social Support (MSPSS) - 6 months(6 months post-enrollment or post intervention initiation)
- Patient Health Questionnaire-9 (PHQ-9) - 3 months(3 months post-enrollment or post intervention initiation)
- Patient Health Questionnaire-9 (PHQ-9) - 6 months(6 months post-enrollment or post intervention initiation)
- Post-traumatic stress (IES-Revised) - 3 months(3 months post-enrollment or post intervention initiation)
- Post-traumatic stress (IES-Revised) - 6 months(6 months post-enrollment or post intervention initiation)
- Insomnia Severity Index (ISI) - 3 months(3 months post-enrollment or post intervention initiation)
- Quality of life (EuroQOL-5D-5L score) - 6 months(6 months post-enrollment or post intervention initiation)
- Connor-Davidson Resilience Scale-10 (CD-RISC 10) - 3 months(3 months post-enrollment or post intervention initiation)
- Connor-Davidson Resilience Scale-10 (CD-RISC 10) - 6 months(6 months post-enrollment or post intervention initiation)
研究者
Michael Goldfarb
Attending Staff, Division of Cardiology
Lady Davis Institute
研究点 (2)
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