Clinical trial NCT06320652: Implementation and Evaluation of Telemedicine in Cardiac Rehabilitation
Official title: Implementation and Evaluation of Telemedicine in Cardiac Rehabilitation - a Study on Health Literacy, Health Related Quality of Life, and Family Support
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cardiac Rehabilitation
Keywords: Cardiac rehabilitation
Telemedicine
Video consultation
Home monitoring
Lead sponsor: Copenhagen University Hospital, Hvidovre
Sponsor class: OTHER
Collaborators: name: Hvidovre University Hospital
First posted: 2024-03-20
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: First, all willing patients who are offered cardiac rehabilitation will comprise the control group. Following a period of implementing the adapted co-created cardiac telerehabilitation intervention. Patients in the control group have access to standard care at the cardiac outpatient clinic program comprising standard center-based cardiac rehabilitation. Patients in the intervention group will, in addition to standard care, be offered an individually tailored family-focused cardiac telerehabilitation developed through a co-creative process.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The overall aim is to develop and test the effect of a tailored patient and family focused cardiac tele rehabilitation intervention on health literacy by comparing it to standard care. Furthermore, to evaluate health-related quality of life, family support, and how the patients experience the communication and relationship with outpatient clinic nurses.

Detailed description: The project is designed inspired by The Complex Intervention Framework (MRC-Guidelines) combined with a patient and family participatory design. The project will consist of three sub-studies. The first study is a co-creation development of a model for the cardiac telerehabilitation intervention. The second study is a quasi-experimental study with a quantitative comparison of the group receiving the cardiac telerehabilitation intervention and control group. The third study will be a descriptive qualitative study which aim to investigate patient's experience with CTR using participant observation and individual interview or dyadic interview.

Eligibility criteria: Inclusion Criteria:

* Patients and their family members affiliated with the Department of Cardiology at Amager and Hvidovre Hospital and attending cardiac rehabilitation.
* Patients diagnosed with ischemic heart disease, heart failure, persistent atrial fibrillation, and cardiac valve surgery.

Exclusion Criteria:

* Patients with substantial language barriers and limited cognitive function.
* Patients who can't use a smart phone, tablet, or computer.

Primary outcomes:
measure: Health Literacy Questonnaire
timeFrame: 3 months
Secondary outcomes:
measure: The European Quality of life five dimensions questionnaire
timeFrame: 3 months
measure: The Iceland-Family Perceived Support Questionnaire
timeFrame: 3 months
measure: The eHealth Literacy Questionnaire
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Amager Hvidovre Hospital
name: Stine M Rosenstroem, Post.doc
role: PRINCIPAL_INVESTIGATOR
References: