Web-based Support to Caregivers in Heart Failure

Heart Failure Clinical Trial

Official title:

Web-based Support to Caregivers Supporting a Person With Heart Failure - a Randomised Controlled Trial With a Process Evaluation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04885465
• Other study ID #: Dnr 2019-05310
• Status: Recruiting
• Phase: N/A
• Start date: May 15, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: February 2024
• Source: Linkoeping University
• Contact: Anna Stromberg, PhD
• Phone: +46-73-6569265
• Email: anna.stromberg[@]liu.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Family Caregivers
• Heart Failure

Intervention

Behavioral:
• web-based psychoeducational support
Caregivers in the experimental group will have access to psycho-educational support through a web-based plattform during 3 months.

Locations

Country	Name	City	State
Sweden	Linköping University Hospital	Linköping	Östergötland

Sponsors (1)

Lead Sponsor	Collaborator
Linkoeping University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Social support	Multidimensional Scale of Perceived Social Support, 12 items. Each item is rated on a seven-point Likert-type response format (1 = very strongly disagree; 7 = very strongly agree). A total score is calculated by summing the results for all items. The possible score range is between 12 and 84, the higher the score the higher the perceived social support.	Measured at baseline, after 3 and 6 months
Other	Symptoms of anxiety and depression	Hospital anxiety and depression scale, 7 items for anxiety and 7 items for depression. Min score 0 and max score 21 for each scale, Higher score indicate more symptoms of anxiety and depression	Measured at baseline, after 3 and 6 months
Other	Health related quality of life	EuroQol EQ-5D 5 level, index and VAS 0-100, higher score indicate better health	Measured at baseline, after 3 and 6 months
Primary	Change from baseline to 3 months in preparedness to care for a person with heart failure	Total score of the Preparedness for Caregiving Scale including 8 items, min score 0, max score 32, higher score indicate better preparedness	Measured at baseline, after 3 months
Secondary	Change from baseline to 3 and 6 months in Rewards of Caregiving	Total score of the Rewards of Caregiving Scale including 10 items, min score 0, max score 40, higher score indicate better Rewards of caregiving	Measured at baseline, after 3 and 6 months
Secondary	Change from baseline to 3 and 6 months in Caregiver Competence	Total score of the Caregiver Competence Scale, including 4 item, min score 0, max score 12, higher score indicate better Caregiver Competence	Measured at baseline, after 3 and 6 months
Secondary	Heart Failure-Caregiver burden and stress	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.	Measured at baseline, after 3 and 6 months
Secondary	Perceived control over the heart disease	Total score of the Control Attitude scale- caregiver version 4 item, min score 4, max score 28, higher score indicate better perceived control	Measured at baseline, after 3 and 6 months
Secondary	Change from baseline to 6 months in preparedness to care for a person with heart failure	Total score of the the Preparedness for Caregiving Scale including 8 items, min score 0, max score 32, higher score indicate better preparedness	Measured at baseline, after 6 months
Secondary	Change in knowledge about heart failure in the three subscales	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.	Measured after 3 months
Secondary	Change in caregiver support for heart failure self-care	European Self-care Behaviour Scale - caregiverversion 7 items, Score from 0-100, higher score better support for self-care	Measured at baseline, after 3 and 6 months