Effects of a Self-care Educational Program Via Telerehabilitation on Quality of Life and Caregiver Burden in Amyotrophic Lateral Sclerosis: Randomized Clinical Trial Protocol
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Change in caregiver burden score measured through Zarit scale
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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).
排除标准
- •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
结局指标
主要结局
Change in caregiver burden score measured through Zarit scale
时间窗: Baseline, immediately after the intervention protocol, and after 4 weeks after treatment
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)
次要结局
- Change in pain score measured through McGill Pain Questionnaire(Baseline, immediately after the intervention protocol, and after 4 weeks after treatment)
- Change in stress score measured through Perceived Stress Scale (PSS)(Baseline, immediately after the intervention protocol, and after 4 weeks after treatment)
- Change in depressive symptoms evaluated through Beck Depression Inventory(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)(Baseline, immediately after the intervention protocol, and after 4 weeks after treatment)
- Change in level of physical activity measured through Sênior Saúde Móvel platform(Baseline, daily during the entire intervention protocol, and after 4 weeks after treatment)
- Change in sleep patterns measured through Sênior Saúde Móvel platform(Baseline, daily during the entire intervention protocol, and after 4 weeks after treatment)
- Change in night awakenings measured through Sênior Saúde Móvel platform(Baseline, daily during the entire intervention protocol, and after 4 weeks after treatment)
- Change in heart rate variability measured through Sênior Saúde Móvel platform(Baseline, daily during the entire intervention protocol, and after 4 weeks after treatment)
研究者
Ana Raquel Rodrigues Lindquist, PhD
Research group leader
Universidade Federal do Rio Grande do Norte