Implementation and Evaluation of Telemedicine in Cardiac Rehabilitation

Implementation and Evaluation of Telemedicine in Cardiac Rehabilitation - a Study on Health Literacy, Health Related Quality of Life, and Family Support

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiac Rehabilitation
• Intervention / Treatment: Other: Cardiac telerehabilitation (video consultation and home monitoring)

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.

• Study Type: Interventional
• Enrollment (Estimated): 140
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nina C Tjustrup, PhD student; Phone Number: +4529213882; Email: nina.cecilie.tjustrup@regionh.dk
• Study Contact Backup: Name: Stine M Rosenstroem, Post.doc; Phone Number: +4530277208; Email: stine.maria.rosenstroem@regionh.dk

Study Locations

• Denmark
  • Hvidovre, Denmark, 2650
    • Recruiting
    • University Hospital Amager and Hvidovre
    • Contact: Phone Number: 30545734; Email: nina.cecilie.tjustrup@regionh.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard care; All willing patients who are offered cardiac rehabilitation will comprise the control group. Patients in the control group will have access to standard care at the cardiac outpatient clinic program comprising standard center-based cardiac rehabilitation. 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 family members attendig the patients cardiac rehabilitation will recive a questionnaire on support fra the outpatient clinic nurses 3 months after the first consultation.
Experimental: Cardiac Telerehabilitation; 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.	Other: Cardiac telerehabilitation (video consultation and home monitoring); Patients with cardiac disease and earlier experiences with cardiac rehabilitation, family members, and nurses in the Departments of Cardiology at Amager and Hvidovre Hospital will be invited to work in a partnership and through a course of innovative co-creative workshops. It is recommended that usability studies have 5-15 participants, which is why we plan to enroll 3 cardiac patients, 3 relatives and 3 nurses from the outpatient clinic. Through the workshops, a rehabilitation program offering cardiac telerehabilitation will be co-created to comply with the preferences and perspectives of patients and family members and nurses from the outpatient clinic. Through these workshops we will learn which important components and elements should be prioritized when offering cardiac telerehabilitation (how, when, and why?).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health Literacy Questonnaire	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.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The European Quality of life five dimensions questionnaire	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.	3 months
The Iceland-Family Perceived Support Questionnaire	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.	3 months
The eHealth Literacy Questionnaire	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.	3 months

Collaborators and Investigators

• Sponsor: Copenhagen University Hospital, Hvidovre
• Collaborators: Hvidovre University Hospital
• Investigators: Principal Investigator: Stine M Rosenstroem, Post.doc, Amager Hvidovre Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): August 31, 2027

Study Registration Dates

• First Submitted: March 11, 2024
• First Submitted That Met QC Criteria: March 19, 2024
• First Posted (Actual): March 20, 2024

Study Record Updates

• Last Update Posted (Actual): August 5, 2025
• Last Update Submitted That Met QC Criteria: July 31, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Telemedicine; Cardiac rehabilitation; Home monitoring; Video consultation
• Other Study ID Numbers: CUHospital

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No