Educational Intervention With Digital Technology For Family Caregivers

NCT05553340 | Completed

• 1 other identifier: 20220232
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Caregivers; Health Education

Outcome Measures

Primary Outcomes (2)

• 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.

  at baseline and 3 months after hospital discharge 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

  at baseline and 3 months after hospital discharge of the elderly

Study Arms (2)

Technology Educational

EXPERIMENTAL

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.

Other: Education for caregivers

Usual

NO INTERVENTION

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

Interventions

Education for caregivers OTHER

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.

Technology Educational

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (1)

Lisiane Paskulin

Porto Alegre, Rio Grande do Sul, 90410-000, Brazil

Location

Related Publications (2)

• 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.

  PMID: 29426361 BACKGROUND

• Costa FMD, Canto DFD, Paskulin LMG. Effectiveness of e-share intervention for caregivers of elderly people after stroke: a pragmatic randomized trial. Rev Lat Am Enfermagem. 2025 Feb 17;33:e4467. doi: 10.1590/1518-8345.7414.4467. eCollection 2025.

  PMID: 39969036 DERIVED

MeSH Terms

Conditions

Stroke; Health Education

Interventions

Educational Status; Caregivers

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics; Health Personnel; Health Care Facilities Workforce and Services

Study Officials

• Lisiane Paskulin, doctor

  Hospital de Clínicas de Porto Alegre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2022
• First Posted: September 23, 2022
• Study Start: January 20, 2023
• Primary Completion: July 10, 2023
• Study Completion: January 16, 2024
• Last Updated: January 18, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)