Clinical trial NCT05884034: Effects of a Self-care Educational Program Via Telerehabilitation in Caregivers
Official title: Effects of a Self-care Educational Program Via Telerehabilitation on Quality of Life and Caregiver Burden in Amyotrophic Lateral Sclerosis: Randomized Clinical Trial Protocol
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Quality of Life
Keywords: Caregiver
Caregiver Burden
Telemedicine
Lead sponsor: Universidade Federal do Rio Grande do Norte
Sponsor class: OTHER
First posted: 2023-06-01
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Informal caregiver (i.e., family member, friend, or a caregiver without payment) of an individual with ALS (clinically defined, probable, or possible) diagnosed by a neurologist using the (El Escorial Criteria);
* Informal caregiver of people who did not have any other neurological disease associated with ALS;
* Aged 18 years or above;
* Without cognitive impairment on the Mini-Mental State Examination (MMSE; cutoff point of 25 for literate individuals) for understanding the study and the informed consent form;
* Literate (at least complete primary education).

Exclusion Criteria:

* Health conditions that hinder from exercising safely, such as recent surgeries, fractures; uncontrolled heart, vascular and respiratory disorders; dizziness or vertigo, fainting; oncological diseases; neurological diseases that affect balance and protective reactions;
* Caregivers in the first trimester of pregnancy, due to the risk of the sudden increase in resting heart rate;
* Using psychiatric medication, such as anxiolytics, antidepressants, antipsychotics, and antiepileptics, as the use of these medications may interfere with the results of this study;
* Drop out of two or more consecutive days without replacement

Primary outcomes:
measure: Change in caregiver burden score measured through Zarit scale
timeFrame: Baseline, immediately after the intervention protocol, and after 4 weeks after treatment
Secondary outcomes:
measure: Change in quality of life score measured through World Health Organization Quality of Life-100 (WHOQOL-BREF)
timeFrame: Baseline, immediately after the intervention protocol, and after 4 weeks after treatment
measure: Change in pain score measured through McGill Pain Questionnaire
timeFrame: Baseline, immediately after the intervention protocol, and after 4 weeks after treatment
measure: Change in stress score measured through Perceived Stress Scale (PSS)
timeFrame: Baseline, immediately after the intervention protocol, and after 4 weeks after treatment
measure: Change in depressive symptoms evaluated through Beck Depression Inventory
timeFrame: Baseline, immediately after the intervention protocol, and after 4 weeks after treatment
measure: Change in night awakenings measured through Sênior Saúde Móvel platform
timeFrame: Baseline, daily during the entire intervention protocol, and after 4 weeks after treatment
measure: Change in sleep patterns measured through Sênior Saúde Móvel platform
timeFrame: Baseline, daily during the entire intervention protocol, and after 4 weeks after treatment
measure: Change in level of physical activity measured through Sênior Saúde Móvel platform
timeFrame: Baseline, daily during the entire intervention protocol, and after 4 weeks after treatment
measure: Change in heart rate variability measured through Sênior Saúde Móvel platform
timeFrame: Baseline, daily during the entire intervention protocol, and after 4 weeks after treatment
Other outcomes:
Locations:
city: Natal
country: Brazil
facility: Federal University of Rio Grande do Norte
state: Rio Grande Do Norte
Study officials:
affiliation: Universidade Federal do Rio Grande do Norte
name: Ana R Lindquist, PhD
role: STUDY_CHAIR
References: