Effects of a Self-care Educational Program Via Telerehabilitation in Caregivers
1 other identifier
interventional
22
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable quality-of-life
Started Jun 2023
Shorter than P25 for not_applicable quality-of-life
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 18, 2023
CompletedFirst Posted
Study publicly available on registry
June 1, 2023
CompletedStudy Start
First participant enrolled
June 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedJune 1, 2023
May 1, 2023
4 months
May 18, 2023
May 29, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
Baseline, immediately after the intervention protocol, and after 4 weeks after treatment
Secondary Outcomes (8)
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 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 night awakenings measured through Sênior Saúde Móvel platform
Baseline, daily during the entire intervention protocol, and after 4 weeks after treatment
- +3 more secondary outcomes
Study Arms (2)
Telerehabilitation group
EXPERIMENTALSelf-care educational program via telerehabilitation
Education group
ACTIVE COMPARATORSelf-care educational program via informative booklet
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Federal University of Rio Grande do Norte
Natal, Rio Grande do Norte, 59078-970, Brazil
Related Publications (1)
Gomes de Souza E Silva EM, Tomaz da Silva S, Januario de Holanda L, Tezoni Borges D, Mendonca Fernandes AP, Evangelista Rodrigues da Silva K, Souza Ribeiro T, Protasio de Melo L, de Medeiros Valentim RA, Alves Pinto Nagem D, Rodrigues Lindquist AR. 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. Front Psychol. 2023 Aug 17;14:1164370. doi: 10.3389/fpsyg.2023.1164370. eCollection 2023.
PMID: 37663359DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Ana R Lindquist, PhD
Universidade Federal do Rio Grande do Norte
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research group leader
Study Record Dates
First Submitted
May 18, 2023
First Posted
June 1, 2023
Study Start
June 1, 2023
Primary Completion
October 1, 2023
Study Completion
December 1, 2023
Last Updated
June 1, 2023
Record last verified: 2023-05