Web-based Support to Caregivers in Heart Failure

Sponsor

Linkoeping University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04885465

Collaborator

(none)

300

Enrollment

Arms

55.6

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure Family Caregivers	Behavioral: web-based psychoeducational support	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Care Provider, Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

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

Anticipated Study Start Date :

May 15, 2021

Anticipated Primary Completion Date :

Dec 31, 2024

Anticipated Study Completion Date :

Dec 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention group Study participants will receive a web-based support program	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.
No Intervention: 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

Arm

Intervention/Treatment

Experimental: Intervention group

Study participants will receive a web-based support program

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.

No Intervention: 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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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
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
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
Change in knowledge about heart failure in the three subscales [Measured after 3 months]
Revised Dutch heart failure knowledge scale including 15 items + 3 items + 3 items
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

Other Outcome Measures

Social support [Measured at baseline, after 3 and 6 months]
Multidimensional Scale of Perceived Social Support, 12 items
Symptoms of anxiety and depression [Measured at baseline, after 3 and 6 months]
Hospital anxiety and depression scale
Health related quality of life [Measured at baseline, after 3 and 6 months]
EuroQol EQ-5D 5 level

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria: A close relative identified by the patient, who cares for, supports or helps a 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) or have a serious disease with expected short survival.