The purpose of this study is to evaluate the effects of a self-care educational program via telerehabilitation on the quality of life, burden, stress, pain, and depression of caregivers of people with ALS.
This study is a randomized clinical trial that will be developed at the Laboratory of Intervention and Analysis of Movement (LIAM) of the Physiotherapy Department of the Federal University of Rio Grande do Norte (UFRN). The participants of this study will comprise informal caregivers of ALS people living in the municipalities of Natal (Rio Grande do Norte, Brazil), aged 18 years or above, of both sexes. The research sample will be allocated randomly into two distinct groups: control group (GC) and experimental group (GE). This research was submitted to the Research Ethics Committee (REC) (no. 4.076.825/20). All participants will be informed about the aim of the study before the program and sign the informed consent form, following the Resolution 466/2012 of the National Health Council and the Declaration of Helsinki. All participants will undergo an assessment at baseline, immediately after the six-week program, and 30 days after the end of the program. A researcher not involved in the intervention will conduct all evaluations remotely via Whatsapp or Google Meet. Analyzed outcomes 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). GE group will receive an informative booklet for caregivers in person and will be divided into subgroups. Each subgroup will participate in a six-week self-care education program with weekly synchronous meetings using Google Meet or WhatsApp. Each meeting will address topics related to the physical and mental health of caregivers, including the importance of care and caregivers, physical activities to be performed at home, routine management and healthy eating. Participants allocated to the CG group will receive the same booklet. In addition, they will receive guidance on the importance of reading and applying the guidelines in the booklet. After the baseline assessment, trained researchers will contact the participants in the second and sixth week of the study to verify their physical and mental health and whether they are performing physical activities and having difficulties living with the individual with ALS.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Enrollment
22
Subjects will participate in a six-week self-care education program with weekly synchronous meetings using Google Meet or WhatsApp and an informative booklet containing guidelines for performing physical activities at home and information on healthy eating, mental health and routine management, with a schedule for weekly organization.
Participants will receive an informative booklet containing guidelines for performing physical activities at home and information on healthy eating, mental health and routine management, with orientations on the importance of reading and implementing the guidelines described in the booklet.
Federal University of Rio Grande do Norte
Natal, Rio Grande do Norte, Brazil
Change in caregiver burden score measured through Zarit scale
Measured through Zarit scale. The analyzed variable will be the score obtained from 22 questions scored on a 5-point Likert scale, from 0 (never) to 4 (nearly always)
Time frame: Baseline, immediately after the intervention protocol, and after 4 weeks after treatment
Change in quality of life score measured through World Health Organization Quality of Life-100 (WHOQOL-BREF)
Measured through World Health Organization Quality of Life-100 (WHOQOL) BREF, wich is a 0-100 scale scored in a positive direction (i.e. higher scores denote higher quality of life). The analyzed variable will be the score obtained from 26 questions.
Time frame: Baseline, immediately after the intervention protocol, and after 4 weeks after treatment
Change in pain score measured through McGill Pain Questionnaire
Measured through McGill Pain Questionnaire, wich is a 0-78 scale scored in a negative direction (i.e. higher scores denote higher pain). The analyzed variable will be the score obtained from 78 descriptors of pain organized into four categories (sensory, affective, evaluative, and miscellaneous) and 20 subcategories.
Time frame: Baseline, immediately after the intervention protocol, and after 4 weeks after treatment
Change in stress score measured through Perceived Stress Scale (PSS)
Measured through PSS. The analyzed variable will be the score obtained from 14 questions scoring from 0 to 4 (0 = never, 1 = almost never, 2 = sometimes, 3 = almost always, and 4 = always).
Time frame: Baseline, immediately after the intervention protocol, and after 4 weeks after treatment
Change in depressive symptoms evaluated through Beck Depression Inventory
Measured through Beck Depression Inventory, wich is a 0-63 scale scored in a negative direction (i.e. higher scores denote more depression). The analyzed variable will be the score obtained from 21 items regarding attitudes and symptoms of depression.
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Time frame: Baseline, immediately after the intervention protocol, and after 4 weeks after treatment
Change in night awakenings measured through Sênior Saúde Móvel platform
Measured by Sênior Saúde Móvel platform. This data will be acquired through a wearable device and used in specific applications of algorithms capable of performing the screening and will be automatically sent to the Sênior Saúde Móvel platform.
Time frame: Baseline, daily during the entire intervention protocol, and after 4 weeks after treatment
Change in sleep patterns measured through Sênior Saúde Móvel platform
Measured by Sênior Saúde Móvel platform.
Time frame: Baseline, daily during the entire intervention protocol, and after 4 weeks after treatment
Change in level of physical activity measured through Sênior Saúde Móvel platform
Measured by Sênior Saúde Móvel platform.
Time frame: Baseline, daily during the entire intervention protocol, and after 4 weeks after treatment
Change in heart rate variability measured through Sênior Saúde Móvel platform
Measured by Sênior Saúde Móvel platform.
Time frame: Baseline, daily during the entire intervention protocol, and after 4 weeks after treatment