Clinical trial NCT04885465: Web-based Support to Caregivers in Heart Failure
Official title: Web-based Support to Caregivers Supporting a Person With Heart Failure - a Randomised Controlled Trial With a Process Evaluation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Failure
Family Caregivers
Keywords: heart failure
caregiver
carer
preparedness
Perceived control
Lead sponsor: Linkoeping University
Sponsor class: OTHER_GOV
First posted: 2021-05-13
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: Change from baseline to 3 months in preparedness to care for a person with heart failure
timeFrame: Measured at baseline, after 3 months
Secondary outcomes:
measure: Change from baseline to 3 and 6 months in Rewards of Caregiving
timeFrame: Measured at baseline, after 3 and 6 months
measure: Change from baseline to 3 and 6 months in Caregiver Competence
timeFrame: Measured at baseline, after 3 and 6 months
measure: Heart Failure-Caregiver burden and stress
timeFrame: Measured at baseline, after 3 and 6 months
measure: Perceived control over the heart disease
timeFrame: Measured at baseline, after 3 and 6 months
measure: Change from baseline to 6 months in preparedness to care for a person with heart failure
timeFrame: Measured at baseline, after 6 months
measure: Change in knowledge about heart failure in the three subscales
timeFrame: Measured after 3 months
measure: Change in caregiver support for heart failure self-care
timeFrame: Measured at baseline, after 3 and 6 months
Other outcomes:
measure: Social support
timeFrame: Measured at baseline, after 3 and 6 months
measure: Symptoms of anxiety and depression
timeFrame: Measured at baseline, after 3 and 6 months
measure: Health related quality of life
timeFrame: Measured at baseline, after 3 and 6 months
Locations:
city: Linköping
country: Sweden
facility: Linköping University Hospital
state: Östergötland
Study officials:
affiliation: Linkoeping University
name: Anna Strömberg, PhD
role: PRINCIPAL_INVESTIGATOR
References: