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在乌干达实施和评估基于手机的、以家庭为中心的中风康复方案(F@ce 2.0):一项随机对照试验方案。

Implementing and Evaluating a Mobile Phone-Supported and Family-Centered Rehabilitation Program for People With Stroke in Uganda (F@ce 2.0): Protocol for a Randomized Controlled Trial.

机构信息

Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden.

Uganda Allied Health Examinations Board, Kampala, Uganda.

出版信息

JMIR Res Protoc. 2024 Sep 25;13:e60955. doi: 10.2196/60955.

Abstract

BACKGROUND

Stroke is a global societal challenge. Annually, 13 million people experience stroke, and the prevalence of stroke is increasing in low-income countries; hence, accessible rehabilitation needs to be developed. Information and communication technology can help by providing access to rehabilitation support through information, self-evaluation, and self-management of rehabilitation. The F@ce 2.0 rehabilitation program provides support in goal-setting and problem-solving strategies through phone calls from the interventionist twice a week and daily SMS text message reminders over 8 weeks to improve performance in valued activities in everyday life. Our hypothesis is that F@ce 2.0 will increase functioning in daily activities and participation in everyday life as well as improve performance and satisfaction in valued daily activities and self-efficacy (ie, confidence in own ability to perform activities) among people living with the consequences of stroke.

OBJECTIVE

This study aims to implement F@ce 2.0, a mobile phone-supported and family-centered rehabilitation program, and evaluate its effects on performance in daily activities and participation in everyday life in comparison to ordinary rehabilitation among persons with stroke and their family members in Uganda. An additional aim is to explore experiences of participating in F@ce 2.0 and plausible mechanisms of impact that might explain the potential effects of F@ce 2.0.

METHODS

A randomized controlled trial will be conducted to compare the outcomes of the F@ce 2.0 group and a control group receiving ordinary rehabilitation. Health care professionals will recruit 90 clients from both urban and rural areas. The primary outcomes for persons with stroke are perceived performance in daily activities assessed using the Canadian Occupational Performance Measure and self-efficacy assessed using the Self-Efficacy Scale; for family members, the primary outcome is caregiver burden evaluated using the Caregiver Burden Scale. Descriptive statistics will be used to present characteristics and outcomes at 3 and 6 months. All statistical analyses comparing the outcomes at the different time points between the F@ce 2.0 and control groups will be performed using intention-to-treat analysis. Qualitative interviews will be used to explore the experiences of persons with stroke and their family members participating in F@ce 2.0, using a grounded theory approach to data collection and analysis. A process evaluation will be conducted using a single-case study design with mixed methods to explore the implementation process.

RESULTS

Recruitment and data collection in the randomized controlled trial were initiated in January 2022 and have been completed. The intervention has been provided to 51 participants in the intervention group. Interviews of persons with stroke, family members, and health care professionals have been conducted. Data analysis will be performed during autumn 2024 and spring 2025.

CONCLUSIONS

This study will provide evidence of the plausible effects of F@ce 2.0 and the process of implementing the program in low-income countries.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/60955.

摘要

背景

中风是一个全球性的社会挑战。每年有 1300 万人经历中风,中风的发病率在低收入国家正在上升;因此,需要开发可及的康复手段。信息和通信技术可以通过提供康复支持来帮助,包括通过信息、自我评估和康复的自我管理来改善日常生活中有价值活动的表现。F@ce 2.0 康复计划通过每周两次干预者的电话和 8 周内每天的短信提醒,为设定目标和解决问题策略提供支持,以改善日常生活中价值活动的表现和参与度。我们的假设是,F@ce 2.0 将提高中风患者及其家庭成员日常生活活动中的功能表现和参与度,并提高有价值日常活动中的表现和满意度以及自我效能(即对自己执行活动能力的信心)。

目的

本研究旨在实施 F@ce 2.0,这是一个基于移动电话和以家庭为中心的康复计划,并评估其在乌干达中风患者及其家庭成员中的日常活动表现和参与度方面与普通康复相比的效果。另一个目的是探讨参与 F@ce 2.0 的体验以及可能解释 F@ce 2.0 潜在效果的影响机制。

方法

将进行一项随机对照试验,比较 F@ce 2.0 组和接受普通康复的对照组的结果。卫生保健专业人员将从城市和农村地区招募 90 名患者。中风患者的主要结局是使用加拿大职业表现量表评估的感知日常活动表现和使用自我效能量表评估的自我效能;对于家庭成员,主要结局是使用照顾者负担量表评估的照顾者负担。将使用描述性统计来呈现 3 个月和 6 个月时的特征和结果。将使用意向治疗分析比较 F@ce 2.0 组和对照组在不同时间点的结果。将使用扎根理论方法收集和分析数据,对中风患者及其家庭成员参与 F@ce 2.0 的体验进行定性访谈。将使用单一案例研究设计和混合方法进行过程评估,以探索实施过程。

结果

随机对照试验的招募和数据收集于 2022 年 1 月开始,并已完成。已向干预组的 51 名参与者提供了干预措施。已对中风患者、家庭成员和卫生保健专业人员进行了访谈。数据分析将于 2024 年秋季和 2025 年春季进行。

结论

本研究将提供 F@ce 2.0 的可能效果和在低收入国家实施该计划的过程的证据。

国际注册报告标识符(IRRID):DERR1-10.2196/60955。

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Nat Rev Neurol. 2021 Oct;17(10):634-656. doi: 10.1038/s41582-021-00542-4. Epub 2021 Sep 15.

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