Clinical trial NCT05553340: Educational Intervention With Digital Technology For Family Caregivers
Official title: Educational Intervention With Digital Technology For Family Caregivers Of Elderly After Stroke: Randomized Pragmatic Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Caregivers
Health Education
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2022-09-23
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Change the capacity of informal caregivers to care for the elderly after stroke
timeFrame: at baseline and 3 months after hospital discharge of the elderly
measure: Change the performance of informal caregivers to care for the elderly after stroke
timeFrame: at baseline and 3 months after hospital discharge of the elderly
Secondary outcomes:
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Lisiane Paskulin
state: Rio Grande Do Sul
Study officials:
affiliation: Hospital de Clínicas de Porto Alegre
name: Lisiane Paskulin, doctor
role: PRINCIPAL_INVESTIGATOR
References:
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.