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临床试验/NCT04535284
NCT04535284Unknown不适用

Coaching Intervention for Caregivers of Persons With Stroke

Thomas Jefferson University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2020年8月24日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
80
试验地点
1
主要终点
Canadian Occupational Performance Measure

研究概览

简要总结

Caregivers of people with stroke experience strain that can reduce their quality of life. Caregivers are routinely engaged during hospital discharge for education and training related to the person with stroke. However, the critical period after stroke survivor's discharge is largely unsupported for the caregiver. This proposed study is a randomized controlled trial that will provide post-discharge support for caregivers using a health coaching program as compared to usual care and examine its effect of caregivers and people with stroke.

详细描述

Caregiver strain reduces quality of life and can increase the chance of unplanned hospital readmission for the person with stroke. Caregivers are routinely engaged during hospital discharge for education and training. However, the critical period after discharge is largely unsupported. The proposed research will integrate occupational therapy and telehealth to provide a post-discharge, caregiver-focused program, the "Health Coaching-in-Context" that consists of up to 10 sessions, arranged once-a-week or multiple times a week based on convenience of scheduling for up to 10 weeks. The program targets improved caregiver health and reduction in readmissions for stroke survivor. The study aims to examine the effects of the coaching program for caregivers as compared to usual care and evaluate the feasibility of study design. A pilot randomized controlled trial will be conducted with two parallel groups, "Health Coaching-in-Context" and usual care. A sample of up to 40 pairs, including up to 40 stroke survivors and their respective 40 caregivers will be recruited from University hospitals and randomly assigned after consenting. The occupational therapist, unaware of the group assignment, will administer assessments before and after the intervention, and at 4-week follow-up. Data will be collected on general information, readmissions, performance, self-efficacy, and quality of life.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

Assessor will be blinded to treatment group allocation

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Survivor criteria: First-time stroke, discharged from hospital within the past 30 days.
  • •Caregiver criteria: Informal caregiver primarily responsible for care (family member, friend, or partner), may or may not live in the same household. Passes cognition screen, willing to use teleconference using phone, tablet, or computer.
  • •Both: 18 to 80 years of age, understand and speak English

排除标准

  • •81 years of age or older
  • •Unable to understand and speak English
  • •Does not provide consent
  • •Caregiver does not pass cognition screen

研究组 & 干预措施

Coaching

Experimental

Health Coaching-in-Context" includes coaching by trained coaches up to 10 sessions over teleconference.

干预措施: Coaching (Behavioral)

Usual Care

No Intervention

The usual care group does not get any intervention but continues with any of their usual activities that would otherwise would have been provided to them.

结局指标

主要结局

Canadian Occupational Performance Measure

时间窗: Week 15

Measure of performance and satisfaction with performance of daily tasks. Each domain score is out of 10, minimum is 1, and higher scores are better.

Canadian Occupational Performance Measure

时间窗: Week 1

Measure of performance and satisfaction with performance of daily tasks. Each domain score is out of 10, minimum is 1, and higher scores are better.

Canadian Occupational Performance Measure

时间窗: Week 12

Measure of performance and satisfaction with performance of daily tasks.Each domain score is out of 10, minimum is 1, and higher scores are better.

次要结局

  • Stroke Impact Scale(Week 15)
  • Revised Caregiver Self-efficacy scale(Week 15)
  • Single-item life satisfaction scale(Week 15)
  • Re-admission(90 day re-admission)
  • Zarit Burden Interview(Week 15)
  • WHO-BREF Quality of Life scale(Week 15)
  • Re-admission(30 day re-admission)
  • Re-admission(60 day re-admission)
  • Revised Caregiver Self-efficacy scale(Week 1)
  • Revised Caregiver Self-efficacy scale(Week 12)
  • Zarit Burden Interview(Week 1)
  • Zarit Burden Interview(Week 12)
  • WHO-BREF Quality of Life scale(Week 1)
  • WHO-BREF Quality of Life scale(Week 12)
  • Single-item life satisfaction scale(Week 1)
  • Single-item life satisfaction scale(Week 12)
  • Stroke Impact Scale(Week 1)
  • Stroke Impact Scale(Week 12)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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