Effects of a Self-care Educational Program Via Telerehabilitation in Caregivers

NCT ID: NCT05884034

Last Updated: 2023-06-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-30
• Study Completion Date: 2023-12-31

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.

Conditions

Quality of Life

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

Telerehabilitation group

Self-care educational program via telerehabilitation

Group Type: EXPERIMENTAL

Telerehabilitation

Intervention Type: OTHER

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.

Education group

Self-care educational program via informative booklet

Group Type: ACTIVE_COMPARATOR

Education

Intervention Type: OTHER

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.

Interventions

Telerehabilitation

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.

Intervention Type: OTHER

Education

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universidade Federal do Rio Grande do Norte

OTHER

Sponsor Role: lead

Responsible Party

Ana Raquel Rodrigues Lindquist, PhD

Research group leader

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ana R Lindquist, PhD

Role: STUDY_CHAIR

Universidade Federal do Rio Grande do Norte

Locations

Federal University of Rio Grande do Norte

Natal, Rio Grande do Norte, Brazil

Countries

Brazil

Central Contacts

Ana R Lindquist, PhD

Role: CONTACT

Raquel.lindquist@ufrn.br

+55 84 8117-5502

Daniel T Borges, PhD

Role: CONTACT

daniel.borges.t@gmail.com

+55 84 96342296

References

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.

Reference Type: DERIVED

PMID: 37663359 (View on PubMed)

Other Identifiers

CEP/UFRN 4.076.825/20

Identifier Type: -

Identifier Source: org_study_id