- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05553340
Educational Intervention With Digital Technology For Family Caregivers (eshare)
January 17, 2024 updated by: Hospital de Clinicas de Porto Alegre
Educational Intervention With Digital Technology For Family Caregivers Of Elderly After Stroke: Randomized Pragmatic Trial
Family caregivers of elderly stroke survivors face challenging difficulties such as the lack of support and the knowledge and skills to practice home care.
The aim of this research is to compare the effect of an educational intervention for informal caregivers of elderly stroke survivors, in their capacity to care.
A pragmatic randomized clinical trial, blinded for outcome assessment, will be conducted at a university hospital in the south of Brazil.
Caregivers will be recruited and divided into two groups: intervention group and control group.
The intervention will consist in a course in digital format developed by nurses to help the family caregiver of elderly people after a stroke to take care of their relative after hospital discharge.
The control group will not receive the intervention.
The primary outcome will be the caregivers' capacity to care.
The study was submitted to the evaluation of the institution's ethics committee.
All participants will signed the informed consent, which ensured voluntary and anonymous participation, as well as freedom to withdraw from the study at any time, without prejudice in the hospitalisation and in the relationship with the health team at the study site.
Study Overview
Detailed Description
Stroke is the second leading cause of death and disability in Brazil, being more prevalent in the elderly.
This event can cause a loss of functional capacity for the patient and the consequent need for a caregiver who needs to receive guidance on how to perform care, especially since the transition of care from the hospital to the home is one of the most critical periods, in which the family requires greater support.
Thus, a structured intervention for training the caregiver, starting at hospital admission, with follow-up after discharge, is considered a requirement of good practices.
With the COVID-19 pandemic, virtual strategies to support caregivers have been more used.
The aim of this study is to analyze the effectiveness of a virtual educational intervention on the ability and performance of family caregivers to care for elderly people with stroke sequelae.
This is a pragmatic randomized study with caregivers of elderly patients hospitalized at Hospital de Clínicas de Porto Alegre for stroke.
Participants will be recruited at the Emergency Service, the Stroke Special Care Unit and other clinical inpatient units.
Family caregivers over the age of 18 with internet and telephone access will be included.
Participants will be randomized into an intervention group (29) and a control group (29), using a list generated on the randomization.com
page.
The intervention for the IG will be carried out by nurses and will consist of a virtual educational action through a massive, open and online course (MOOC), in addition to telephone contacts made in: seven days, 30 days, 60 days and 80 days after discharge .
A hotline will also be available for participants to contact if they have any questions.
The intervention aims to equip the family caregiver to assist the elderly person at home in care, such as hygiene, feeding, positioning and transfer, based on the previously validated Guidance Manual for Family Caregivers of Elderly People with Stroke.
Identification, sociodemographic and health data of the elderly and their caregivers will be collected.
The Capacity Scale for Informal Caregivers of Elderly Stroke Patients (ECCIID-AVC), the Nursing Outcomes Classification (NOC) through selected results and indicators and the Caregiver Burden Scale (CBS) will be applied to the caregiver.
The Functional Independence Measure (MIF) and data on readmissions will be applied to the elderly, all scales being validated for use in Brazil.
Three months after hospital discharge (90 days), caregivers and elderly people will be reassessed with the same instruments.
Control group participants will receive initial and final assessments.
For data analysis, the Statistical Package for the Social Sciences (SPSS) version 21.0 will be used.
The intention-to-treat technique will be used and continuous variables will be described as mean and standard deviation, or median and interquartile range.
For categorical variables, absolute numbers and relative frequencies will be used.
According to the data distribution, the basal characteristics of the groups will be compared by Student's t test and Mann-Whitney.
To analyze the effectiveness of the intervention on the outcomes, the difference between baseline and final scores will be evaluated by the paired Student's t test, with a confidence interval of 95%, and will be considered a significant value p<0.05.
The project will be submitted to the HCPA Research Ethics Committee.
Study Type
Interventional
Enrollment (Actual)
58
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Lisiane Paskulin, doctor
- Phone Number: +555133598275
- Email: paskulin@orion.ufrgs.br
Study Locations
-
-
Rio Grande Do Sul
-
Porto Alegre, Rio Grande Do Sul, Brazil, 90410-000
- Lisiane Paskulin
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- family caregivers aged over 18 years who act as the main unpaid care provider for patients aged 60 years or older, with a medical diagnosis of stroke in the current hospitalization, treated at the Hospital de Clínicas de Porto Alegre.
Exclusion Criteria:
- caregivers of elderly people residing in a long-stay institution;
- do not have access to the internet and access device, or who are not able to use them, verified through a checklist prepared for the study;
- do not have a telephone line for contact;
- they are not interested in receiving the educational intervention;
- are accompanying elderly people with a Modified Rankin Scale (mRankin) of score 6 (which means death), in the enrollment phase of the study participants.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Technology Educational
The intervention will be carried out by nurses and will consist of a virtual educational action through a massive, open and online course (MOOC) that seeks to equip the family caregiver to assist the elderly at home in care, such as hygiene, feeding, positioning and transfer, based on in the Guidance Manual for Family Caregivers of Elderly People with Stroke.
A hotline will also be available for participants to contact if they have any questions.
|
The intervention will aim to equip the family caregiver to assist the elderly in activities of daily living after discharge, and will be carried out by two researchers, through an online course.
The course includes the skills required and included in the scales that assess the caregiver's knowledge and performance.
The course is divided into 12 modules that can be accessed as many times as needed by caregivers, in random order, according to the care needs of the elderly and the caregiver.
|
No Intervention: Usual
Control group participants will receive initial and final assessments, but will not have access to the course.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change the capacity of informal caregivers to care for the elderly after stroke
Time Frame: at baseline and 3 months after hospital discharge of the elderly
|
Capacity Scale for Informal Caregivers of Elderly Stroke Patients - score from zero to 87 points, and the higher the score, the more capable the caregiver is to provide care in the activities of the elderly.
|
at baseline and 3 months after hospital discharge of the elderly
|
Change the performance of informal caregivers to care for the elderly after stroke
Time Frame: at baseline and 3 months after hospital discharge of the elderly
|
Nursing Outcomes Classification - 5-point Likert scale in which a higher score means better performance
|
at baseline and 3 months after hospital discharge of the elderly
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Lisiane Paskulin, doctor, Hospital de Clinicas de Porto Alegre
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 20, 2023
Primary Completion (Actual)
July 10, 2023
Study Completion (Actual)
January 16, 2024
Study Registration Dates
First Submitted
August 1, 2022
First Submitted That Met QC Criteria
September 21, 2022
First Posted (Actual)
September 23, 2022
Study Record Updates
Last Update Posted (Actual)
January 18, 2024
Last Update Submitted That Met QC Criteria
January 17, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20220232
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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