Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2025-12-26 @ 4:26 PM
Study NCT ID:
NCT05884034
Status:
UNKNOWN
Last Update Posted:
2023-06-01
First Post:
2023-05-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of a Self-care Educational Program Via Telerehabilitation in Caregivers
Sponsor:
Universidade Federal do Rio Grande do Norte
Organization:
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2023-05
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: