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

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).