Web-based Support to Caregivers in Heart Failure

NCT ID: NCT04885465

Last Updated: 2024-02-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-15
• Study Completion Date: 2025-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Intervention group

Study participants will receive a web-based support program

Group Type: EXPERIMENTAL

web-based psychoeducational support

Intervention Type: BEHAVIORAL

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

Control group waiting list

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

web-based psychoeducational support

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Linkoeping University

OTHER_GOV

Sponsor Role: lead

Responsible Party

Anna Stroemberg

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anna Strömberg, PhD

Role: PRINCIPAL_INVESTIGATOR

Linkoeping University

Locations

Linköping University Hospital

Linköping, Östergötland County, Sweden

Site Status: RECRUITING

Countries

Sweden

Central Contacts

Anna Stromberg, PhD

Role: CONTACT

anna.stromberg@liu.se

+46-73-6569265

Facility Contacts

Anna Strömberg, PhD

Role: primary

anna.stromberg@liu.se

+46736569265

Other Identifiers

Dnr 2019-05310

Identifier Type: -

Identifier Source: org_study_id