Web-based Support to Caregivers in Heart Failure

Not Applicable

Recruiting

• Conditions: Family Caregivers; Heart Failure

• Registration Number: NCT04885465
• Lead Sponsor: Linkoeping University

Brief Summary

Caregivers of people with heart failure experience a lack of support from health care in their caring role. They often want to become more involved in care, receive education and have the opportunity to share experiences with other caregivers.

Objectives and hypothesis: Our hypothesis is that an internet-based support program that is developed in collaboration with caregivers of people with heart failure will increase preparedness to care (Preparedness for Caregiving Scale). We will also evaluate the effects of the support program on the experiences of caring including positive experiences and the impact of care on health and lifestyle (Caregiver Competence Scale, Rewards of Caregiving Scale, Heart Failure-Caregiver Questionnaire) and their management of heart failure (knowledge of heart failure, support for heart failure self-care and perceived control over heart disease). We will also explore if the patients' healthcare consumption is altered when caregivers receive more support.

Method: The project is a randomized controlled study where 300 caregivers from four health care regions will be randomised to either receive a support program via 1177 care guide or to a control group waiting list who receive standard support from health care and municipalities. After the termination of the study participants in the control group will also be offered access to the support program. Data will be collected with questionnaires at baseline and after 3 and 6 months. A process evaluation with semi-structured interviews to describe the relatives' experiences of using the program with be conducted.

Relevance: Caregivers have been involved in all stages of the development of the Internet-based support program. The evaluation focuses on both the effects of the intervention and factors that affect implementation and equality. Caregiver support that is delivered through 1177 care guide enables a more equal, efficient and accessible support for caregivers.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-05-09
• Study First Submitted QC: 2021-05-09
• Study First Posted: 2021-05-13
• Study Start: 2021-05-15
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-06
• Last Update Posted: 2024-02-07
• Primary Completion: 2024-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• A close relative identified by the patient who cares for, supports or helps this patient with a verified heart failure diagnosis ICD codes within I42 or I50 (i.e. all types of heart failure).

Exclusion Criteria

• Relatives who are unable to carry out the data collection or participate in intervention (e.g. non-Swedish speaking, cognitive problems, severe mental illness, addiction)
• The patient or the close relative have a serious disease with expected short survival of < 6 months.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from baseline to 3 months in preparedness to care for a person with heart failure	Measured at baseline, after 3 months	Total score of the Preparedness for Caregiving Scale including 8 items, min score 0, max score 32, higher score indicate better preparedness

Secondary Outcome Measures

Name	Time	Method
Change in caregiver support for heart failure self-care	Measured at baseline, after 3 and 6 months	European Self-care Behaviour Scale - caregiverversion 7 items, Score from 0-100, higher score better support for self-care
Change from baseline to 6 months in preparedness to care for a person with heart failure	Measured at baseline, after 6 months	Total score of the the Preparedness for Caregiving Scale including 8 items, min score 0, max score 32, higher score indicate better preparedness
Change in knowledge about heart failure in the three subscales	Measured after 3 months	Revised Dutch heart failure knowledge scale with 3 subscales: 1. Knowledge subscale 15 items, min score 0 max score 15, higher score indicate better heart failure knowledge. 2. Trust in own HF knowledge subscale 3 items, min score 3 max score 15, higher score indicare better trust. 3. Health literacy subscale 3 items, min score 3 max score 15, higher score indicare better health literacy.
Change from baseline to 3 and 6 months in Caregiver Competence	Measured at baseline, after 3 and 6 months	Total score of the Caregiver Competence Scale, including 4 item, min score 0, max score 12, higher score indicate better Caregiver Competence
Change from baseline to 3 and 6 months in Rewards of Caregiving	Measured at baseline, after 3 and 6 months	Total score of the Rewards of Caregiving Scale including 10 items, min score 0, max score 40, higher score indicate better Rewards of caregiving
Perceived control over the heart disease	Measured at baseline, after 3 and 6 months	Total score of the Control Attitude scale- caregiver version 4 item, min score 4, max score 28, higher score indicate better perceived control
Heart Failure-Caregiver burden and stress	Measured at baseline, after 3 and 6 months	Total score and subscales of the Heart Failure-Caregiver Questionnaire including 21 item in three domains, namely physical (five items), emotional/psychological (11 items) and lifestyle (four items and one stem item). Items are scored on a severity response scale ranging from 'Not at all = 0' to 'A lot = 4'. The total score was the average of the sum of the three domain scores calculated from sum of scores for items answered/total possible score of items answered x 100. The minimum and maximum scores ranged between 0 and 100.Higher score indicate higher caregiver burden.

Trial Locations

Locations (1)

Linköping University Hospital; 🇸🇪 Linköping, Östergötland, Sweden