Quality of LifeNCT05884034
Effects of a Self-care Educational Program Via Telerehabilitation in Caregivers
A study testing Telerehabilitation and Education in people with Quality of Life, run by Universidade Federal do Rio Grande do Norte at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Quality of Life
- What is being tested?
- Telerehabilitation and Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2023to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Federal University of Rio Grande do Norte
Natal, Rio Grande do Norte, 59078-970
About this study
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
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.
Read the 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
- Being tested
- Telerehabilitation, Education
- Keywords
- Caregiver, Caregiver Burden, Telemedicine
- Medical subject headings
- Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelerehabilitationOther
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.
EducationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Telerehabilitation group | Experimental | Self-care educational program via telerehabilitation Receives: Other: Telerehabilitation |
| Education group | Active comparator | Self-care educational program via informative booklet Receives: Other: Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured through World Health Organization Quality of Life-100 (WHOQOL) BREF, wich is a 0-100 scale scored in a positive direction (i.e. higher scores denote higher quality of life). The analyzed variable will be the score obtained from 26 questions.
Measured: Baseline, immediately after the intervention protocol, and after 4 weeks after treatment
Change in pain score measured through McGill Pain Questionnaire
Measured through McGill Pain Questionnaire, wich is a 0-78 scale scored in a negative direction (i.e. higher scores denote higher pain). The analyzed variable will be the score obtained from 78 descriptors of pain organized into four categories (sensory, affective, evaluative, and miscellaneous) and 20 subcategories.
Measured: Baseline, immediately after the intervention protocol, and after 4 weeks after treatment
Change in stress score measured through Perceived Stress Scale (PSS)
Measured through PSS. The analyzed variable will be the score obtained from 14 questions scoring from 0 to 4 (0 = never, 1 = almost never, 2 = sometimes, 3 = almost always, and 4 = always).
Measured: Baseline, immediately after the intervention protocol, and after 4 weeks after treatment
Change in depressive symptoms evaluated through Beck Depression Inventory
Measured through Beck Depression Inventory, wich is a 0-63 scale scored in a negative direction (i.e. higher scores denote more depression). The analyzed variable will be the score obtained from 21 items regarding attitudes and symptoms of depression.
Measured: Baseline, immediately after the intervention protocol, and after 4 weeks after treatment
Change in night awakenings measured through Sênior Saúde Móvel platform
Measured by Sênior Saúde Móvel platform. This data will be acquired through a wearable device and used in specific applications of algorithms capable of performing the screening and will be automatically sent to the Sênior Saúde Móvel platform.
Measured: Baseline, daily during the entire intervention protocol, and after 4 weeks after treatment
Change in sleep patterns measured through Sênior Saúde Móvel platform
Measured by Sênior Saúde Móvel platform.
Measured: Baseline, daily during the entire intervention protocol, and after 4 weeks after treatment
Change in level of physical activity measured through Sênior Saúde Móvel platform
Measured by Sênior Saúde Móvel platform.
Measured: Baseline, daily during the entire intervention protocol, and after 4 weeks after treatment
Change in heart rate variability measured through Sênior Saúde Móvel platform
Measured by Sênior Saúde Móvel platform.
Measured: Baseline, daily during the entire intervention protocol, and after 4 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2023
- Study startJun 2023 (estimated)
- Primary completionOct 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Rio Grande do Norte
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana Raquel Rodrigues Lindquist, PhD, Universidade Federal do Rio Grande do Norte
- Investigators
- Ana R Lindquist, PhD, Study chair, Universidade Federal do Rio Grande do Norte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05884034
- Sponsor's protocol ID
- CEP/UFRN 4.076.825/20
- Status last verified
- May 2023
- First submitted
- 18 May 2023
- Last updated
- 1 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37663359
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05884034
- Acronym / sponsor ID
- CEP/UFRN 4.076.825/20
- Conditions
- Quality of Life
- Keywords
- Caregiver, Caregiver Burden, Telemedicine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Universidade Federal do Rio Grande do NorteUniversity, hospital or other
- Study start
- Jun 2023 (estimated)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 1 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telerehabilitation group | Experimental | Other: TelerehabilitationSelf-care educational program via telerehabilitation |
| Education group | Active comparator | Other: EducationSelf-care educational program via informative booklet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TelerehabilitationSubjects 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. | Other | Telerehabilitation group |
| EducationParticipants 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. | Other | Education group |
Primary outcome
Change in caregiver burden score measured through Zarit scale
Time frame: 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)
8 secondary outcomes
Change in quality of life score measured through World Health Organization Quality of Life-100 (WHOQOL-BREF)
Time frame: Baseline, immediately after the intervention protocol, and after 4 weeks after treatment
Change in pain score measured through McGill Pain Questionnaire
Time frame: Baseline, immediately after the intervention protocol, and after 4 weeks after treatment
Change in stress score measured through Perceived Stress Scale (PSS)
Time frame: Baseline, immediately after the intervention protocol, and after 4 weeks after treatment
Change in depressive symptoms evaluated through Beck Depression Inventory
Time frame: Baseline, immediately after the intervention protocol, and after 4 weeks after treatment
Change in night awakenings measured through Sênior Saúde Móvel platform
Time frame: Baseline, daily during the entire intervention protocol, and after 4 weeks after treatment
Change in sleep patterns measured through Sênior Saúde Móvel platform
Time frame: Baseline, daily during the entire intervention protocol, and after 4 weeks after treatment
Change in level of physical activity measured through Sênior Saúde Móvel platform
Time frame: Baseline, daily during the entire intervention protocol, and after 4 weeks after treatment
Change in heart rate variability measured through Sênior Saúde Móvel platform
Time frame: Baseline, daily during the entire intervention protocol, and after 4 weeks after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2023.
- Derived from this study: PubMed 37663359Gomes 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ana R Lindquist, PhD study chair
Universidade Federal do Rio Grande do Norte
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telerehabilitation and Education in people with Quality of Life, run by Universidade Federal do Rio Grande do Norte at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ana R Lindquist, PhD (+55 84 8117-5502, Raquel.lindquist@ufrn.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in caregiver burden score measured through Zarit scale (time frame: Baseline, immediately after the intervention protocol, and after 4 weeks after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05884034, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2023.