通过远程康复进行的自我护理教育计划对肌萎缩侧索硬化症患者生活质量和照顾者负担的影响：一项单盲随机临床试验方案

Effects of a self-care educational program via telerehabilitation on quality of life and caregiver burden in amyotrophic lateral sclerosis: a single-blinded randomized clinical trial protocol.

作者信息

Gomes de Souza E Silva Emília Márcia, Tomaz da Silva Stephano, Januário de Holanda Ledycnarf, Tezoni Borges Daniel, Mendonça Fernandes Ana Paula, Evangelista Rodrigues da Silva Kelly, Souza Ribeiro Tatiana, Protásio de Melo Luciana, de Medeiros Valentim Ricardo Alexsandro, Alves Pinto Nagem Danilo, Rodrigues Lindquist Ana Raquel

机构信息

Laboratory of Intervention and Analysis of Movement, Department of Physical Therapy, Federal University of Rio Grande do Norte, Natal, Brazil.

Laboratory of Technological Innovation in Health, Federal University of Rio Grande do Norte, Natal, Brazil.

出版信息

Front Psychol. 2023 Aug 17;14:1164370. doi: 10.3389/fpsyg.2023.1164370. eCollection 2023.

DOI:10.3389/fpsyg.2023.1164370

PMID:37663359

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10472276/

Abstract

INTRODUCTION

The implementation of a telerehabilitation protocol for self-care in the routine of caregivers of individuals with amyotrophic lateral sclerosis (ALS) has been associated with reduced levels of stress and improved quality of life. Moreover, it may reduce the difficulty of traveling to perform physical or other self-care activities. Thus, this study designed a clinical trial protocol to investigate the effects of a self-care education program via telerehabilitation on the burden and quality of life of caregivers of individuals with ALS.

METHODS

This single-blinded randomized clinical trial will recruit 26 caregivers and randomly allocate them to the experimental (EG = 13) or control group (CG = 13). The EG will receive an informative booklet and participate in a 6-week synchronous telerehabilitation program with a neuropsychologist, nutritionist, and physiotherapist to discuss physical and mental health. The CG will receive an informative booklet on self-care and physical activity and weekly phone calls for 6 weeks to solve questions about the booklet. Outcomes will include the caregiver burden (Zarit scale), quality of life (World Health Organization Quality of Life BREF), pain (McGill Pain Questionnaire), stress (Perceived Stress Scale), and depression (Beck Depression Inventory), which will be evaluated at the baseline after the six-week program and 30 days after the program. Additionally, we will assess daily the nocturnal awakenings, sleep patterns, level of physical activity, and heart rate variability.

DISCUSSION

This study aimed to investigate the effectiveness of telerehabilitation for caregivers of individuals with ALS. If effective, this program could be disseminated among health professionals, increasing the possibility of remotely monitoring individuals with difficulty performing physical activities.

TRIAL REGISTRATION NUMBER

NCT05884034 (clinicaltrials.gov).

摘要

引言

在肌萎缩侧索硬化症（ALS）患者照料者的日常护理中实施远程康复自我护理方案，与压力水平降低和生活质量改善相关。此外，它可能会减少前往进行身体或其他自我护理活动的出行困难。因此，本研究设计了一项临床试验方案，以调查通过远程康复进行的自我护理教育计划对ALS患者照料者的负担和生活质量的影响。

方法

这项单盲随机临床试验将招募26名照料者，并将他们随机分配到实验组（EG = 13）或对照组（CG = 13）。实验组将收到一本信息手册，并与神经心理学家、营养师和物理治疗师一起参加为期6周的同步远程康复计划，以讨论身心健康问题。对照组将收到一本关于自我护理和体育活动的信息手册，并在6周内每周进行电话沟通，以解答有关手册的问题。结果将包括照料者负担（Zarit量表）、生活质量（世界卫生组织生活质量简表）、疼痛（麦吉尔疼痛问卷）、压力（感知压力量表）和抑郁（贝克抑郁量表），这些将在六周计划后的基线、计划结束后30天进行评估。此外，我们将每天评估夜间觉醒情况、睡眠模式、身体活动水平和心率变异性。