Web-based Support to Caregivers in Heart Failure

NCT04885465 | Completed DMC

• 1 other identifier: Dnr 2019-05310
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure; Family Caregivers

Keywords

heart failure; caregiver; carer; preparedness; Perceived control

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Change from baseline to 3 and 6 months in Rewards of Caregiving

  Measured at baseline, after 3 and 6 months

• Change from baseline to 3 and 6 months in Caregiver Competence

  Measured at baseline, after 3 and 6 months

• Heart Failure-Caregiver burden and stress

  Measured at baseline, after 3 and 6 months

• Perceived control over the heart disease

  Measured at baseline, after 3 and 6 months

• Change from baseline to 6 months in preparedness to care for a person with heart failure

  Measured at baseline, after 6 months

Other Outcomes (3)

• Social support

  Measured at baseline, after 3 and 6 months

• Symptoms of anxiety and depression

  Measured at baseline, after 3 and 6 months

• Health related quality of life

  Measured at baseline, after 3 and 6 months

Study Arms (2)

Intervention group

EXPERIMENTAL

Study participants will receive a web-based support program

Behavioral: web-based psychoeducational support

Control group waiting list

NO INTERVENTION

Study participants in the control group waiting list will receive standard support from health care and municipalities. After study termination they will receive access to the same web-based program as the experimental group

Interventions

web-based psychoeducational support BEHAVIORAL

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

Intervention group

Eligibility Criteria

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

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Linkoeping University: lead

Study Sites (1)

Linköping University Hospital

Linköping, Östergötland County, 581 85, Sweden

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Anna Strömberg, PhD

  Linkoeping University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: May 9, 2021
• First Posted: May 13, 2021
• Study Start: May 15, 2021
• Primary Completion: October 31, 2025
• Study Completion: January 31, 2026
• Last Updated: March 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)