Implementation and Evaluation of Telemedicine in Cardiac Rehabilitation
- Conditions
- Cardiac Rehabilitation
- Interventions
- Other: Cardiac telerehabilitation (video consultation and home monitoring)
- Registration Number
- NCT06320652
- Lead Sponsor
- Copenhagen University Hospital, Hvidovre
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 140
- 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.
- Patients with substantial language barriers and limited cognitive function.
- Patients who can't use a smart phone, tablet, or computer.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cardiac Telerehabilitation Cardiac telerehabilitation (video consultation and home monitoring) Patients in the intervention group will, in addition to standard care, be offered an individually tailored family-focused cardiac telerehabilitation (video consultations and home monitoring) developed through a co-creative process. The cardiac outpatient clinic registers activities and monitors patient participation in cardiac rehabilitation. Data on patient demographic, diagnoses, educational backgrounds, civil status, and patient-reported outcomes will be collected from self-reported questionnaires at baseline, and 3 months after the intervention. The family members attendig the patients cardiac rehabilitation will recive a questionnaire on support fra the outpatient clinic nurses 3 months after the first consultation.
- Primary Outcome Measures
Name Time Method Health Literacy Questonnaire 3 months Health literacy is investigated through instruments such as the Health Literacy Questionnaire (HQL).
The HLQ contains 44 qustions that cover nine conceptually distinct areas of Health Literacy. Response options for each scale are determined by the content and nature of the items. For scale 1-5 four point ordinal response options are used (strongly disagree, disagree, agree and strongly agree), while for scales 6-9 five-point ordinal response options are used (cannot do, very difficult, quite difficult, quite easy and very easy).
HLQ scale scores are calculated as unit-weighted sums of the constituents items averaged by the number of items in the scale such that the nominal range of the scale scores are 1-4 for scale 1-5 and 1-5 for scale 6-9. A low score means worse outcome and a high score means better outcome.
- Secondary Outcome Measures
Name Time Method The European Quality of life five dimensions questionnaire 3 months The European Quality of life (EQ-5D-5L) questionnaire is a well-known generic and validated instrument for measuring health related quality of life, and it is used in a population health surveys, clinical trials and health economics evaluations.
The EQ-5D-5L have five response levels in each dimensions (none, slight, modrate, severe and extreme problems). The EQ-5D-5L health ranges from 11111 corresponding full health to 55555 corresponding the worse health state. The The EQ-5D also include a EQ VAS 0-100 where the 0 is labelled the worst health state and 100 is labelled the best health state.The eHealth Literacy Questionnaire 3 months The eHealth Literacy Questionnaire (eHLQ) consist of seven domains. Each item is scored using af four point ordinal scale, response options: strongly disagree, disagree, agree and strongly agree.
eHLQ scale scores are calculated as unit-weighted sums of the constituents items averaged by the number of items in the scale such that the nominal range of the scale scores are 1-4. A low score means worse outcome and a high score means better outcome.The Iceland-Family Perceived Support Questionnaire 3 months The Iceland-Family Perceived Support Questionnaire (ICE-FPSQ) measures patients and families perceived support from nurses during and after meeting the health care system.
The ICE-FPSQ has 14 qustions and scores range from minimum score of 14 points to a maximum of 70 points on two areas of perceived family support (Cognitive support (5 items) and Emotional support (9 items). Qustions are answered on a five-point Likert scale ranging from 1 (almost never) to 5 (all the time). A high score closer to 70 indicates a positive score.