Linköping University Hospital
Linköping, Östergötland County, 581 85, Sweden
NCT Number: NCT04885465
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Linköping, Östergötland County, 581 85, Sweden
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Caregivers in the experimental group will have access to psycho-educational support through a web-based plattform during 3 months.
Time frame: Measured at baseline, after 3 months
Total score of the Preparedness for Caregiving Scale including 8 items, min score 0, max score 32, higher score indicate better preparedness
Time frame: Measured at baseline, after 3 and 6 months
Total score of the Rewards of Caregiving Scale including 10 items, min score 0, max score 40, higher score indicate better Rewards of caregiving
Time frame: Measured at baseline, after 3 and 6 months
Total score of the Caregiver Competence Scale, including 4 item, min score 0, max score 12, higher score indicate better Caregiver Competence
Time frame: Measured at baseline, after 3 and 6 months
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.
Time frame: Measured at baseline, after 3 and 6 months
Total score of the Control Attitude scale- caregiver version 4 item, min score 4, max score 28, higher score indicate better perceived control
Time frame: Measured at baseline, after 6 months
Total score of the the Preparedness for Caregiving Scale including 8 items, min score 0, max score 32, higher score indicate better preparedness
Time frame: Measured after 3 months
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.
Time frame: Measured at baseline, after 3 and 6 months
European Self-care Behaviour Scale - caregiverversion 7 items, Score from 0-100, higher score better support for self-care
Time frame: Measured at baseline, 3 and 6 months
The Minimal Insomnia Symptom Scale (MISS) is an insomnia-screening tool consisting of 3 items, with 5 response categories (no, minor, moderate, severe and very severe problems), which are scored 0-4, respectively adding up to a total score with a min score of 0, max score of 12, higher score indicate more insomnia and poorer sleep.
Time frame: Measured at baseline, after 3 and 6 months
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.
Time frame: Measured at baseline, after 3 and 6 months
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
Time frame: Measured at baseline, after 3 and 6 months
EuroQol EQ-5D 5 level, index and VAS 0-100, higher score indicate better health
Linkoeping University
Other Gov
Web-based Support to Caregivers Supporting a Person With Heart Failure - a Randomised Controlled Trial With a Process Evaluation
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06847438
Cardiovascular Diseases, Heart Diseases
Atlanta, Georgia, United States
View Trial DetailsNCT07721909
Cardiovascular Diseases, Heart Diseases
Muscat, Oman
View Trial DetailsNCT05820295
Arrhythmias, Cardiac, Atrial Fibrillation
New York, United States
View Trial DetailsNCT05741658
Cardiovascular Diseases, Heart Diseases
Los Angeles, California, United States
View Trial Details