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Educational Intervention With Digital Technology For Family Caregivers (eshare)

Primary Purpose

Stroke

Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Education for caregivers
Sponsored by
Hospital de Clinicas de Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Stroke focused on measuring Caregivers, Health Education

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Lisiane PaskulinRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Technology Educational

Usual

Arm Description

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.

Control group participants will receive initial and final assessments, but will not have access to the course.

Outcomes

Primary Outcome Measures

Change the capacity of informal caregivers to care for the elderly after stroke
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.
Change the performance of informal caregivers to care for the elderly after stroke
Nursing Outcomes Classification - 5-point Likert scale in which a higher score means better performance

Secondary Outcome Measures

Full Information

First Posted
August 1, 2022
Last Updated
July 12, 2023
Sponsor
Hospital de Clinicas de Porto Alegre
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1. Study Identification

Unique Protocol Identification Number
NCT05553340
Brief Title
Educational Intervention With Digital Technology For Family Caregivers
Acronym
eshare
Official Title
Educational Intervention With Digital Technology For Family Caregivers Of Elderly After Stroke: Randomized Pragmatic Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 20, 2023 (Actual)
Primary Completion Date
July 10, 2023 (Actual)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital de Clinicas de Porto Alegre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Caregivers, Health Education

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
58 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Technology Educational
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual
Arm Type
No Intervention
Arm Description
Control group participants will receive initial and final assessments, but will not have access to the course.
Intervention Type
Other
Intervention Name(s)
Education for caregivers
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change the capacity of informal caregivers to care for the elderly after stroke
Description
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.
Time Frame
at baseline and 3 months after hospital discharge of the elderly
Title
Change the performance of informal caregivers to care for the elderly after stroke
Description
Nursing Outcomes Classification - 5-point Likert scale in which a higher score means better performance
Time Frame
at baseline and 3 months after hospital discharge of the elderly

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lisiane Paskulin, doctor
Phone
+555133598275
Email
paskulin@orion.ufrgs.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisiane Paskulin, doctor
Organizational Affiliation
Hospital de Clínicas de Porto Alegre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lisiane Paskulin
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90410-000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lisiane Paskulin, doctor
Phone
+555133598275
Email
paskulin@orion.ufrgs.br

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29426361
Citation
Day CB, Bierhals CCBK, Santos NOD, Mocellin D, Predebon ML, Dal Pizzol FLF, Paskulin LMG. Nursing home care educational intervention for family caregivers of older adults post stroke (SHARE): study protocol for a randomised trial. Trials. 2018 Feb 9;19(1):96. doi: 10.1186/s13063-018-2454-5.
Results Reference
background

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Educational Intervention With Digital Technology For Family Caregivers

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