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RecruitingNCT06320652Updated Aug 5, 2025

Implementation and Evaluation of Telemedicine in Cardiac Rehabilitation

An interventional study of Cardiac telerehabilitation (video consultation and home monitoring) in Cardiac Rehabilitation, sponsored by Copenhagen University Hospital, Hvidovre. Recruiting at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-05.

Sponsored by Copenhagen University Hospital, Hvidovre · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
140
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Cardiac Rehabilitation

Keywords

  • Cardiac rehabilitation
  • Telemedicine
  • Video consultation
  • Home monitoring
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Patients with substantial language barriers and limited cognitive function.
  • Patients who can't use a smart phone, tablet, or computer.
04

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
140 participants (estimated)

Study arms

  • 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)

Interventions

  • OtherCardiac 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?).

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 3 months

Secondary outcomes

  1. 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.

    Time frame: 3 months

  2. 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.

    Time frame: 3 months

  3. 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.

    Time frame: 3 months

06

Study locations

1 of 1 sites recruiting
07

References and documents

Publications

  • Tjustrup NC, Rosenstrom S, Risom SS, Hove JD, Brodsgaard A. Developing a Cardiac TeleRehabilitation model using co-production with patients, family members, and healthcare professionals. Eur J Cardiovasc Nurs. 2026 Jan 21:zvag020. doi: 10.1093/eurjcn/zvag020. Online ahead of print. PubMed 41559760 ↗
  • Rosenstrom S, Cecilie Tjustrup N, Kallemose T, Risom SS, Hove JD, Brodsgaard A. Evaluating a co-created model for video consultations in cardiac rehabilitation: impact on health literacy, quality of life and family support-a study protocol. BMJ Open. 2025 Oct 2;15(10):e101099. doi: 10.1136/bmjopen-2025-101099. PubMed 41043840 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT06320652
Lead sponsor
Copenhagen University Hospital, Hvidovre
Collaborators
Hvidovre University Hospital
Responsible party
Nina Cecilie Tjustrup (PhD student, MSc, RN, Copenhagen University Hospital, Hvidovre) — Principal investigator
First posted
Mar 20, 2024
Start date
May 2, 2024
Primary completion
Dec 31, 2025 (estimated)
Completion
Aug 31, 2027 (estimated)
Last update
Aug 5, 2025

Study contacts

Nina C Tjustrup, PhD student
Contact
nina.cecilie.tjustrup@regionh.dk
+4529213882
Stine M Rosenstroem, Post.doc
Contact
stine.maria.rosenstroem@regionh.dk
+4530277208
Stine M Rosenstroem, Post.doc
principal investigator · Amager Hvidovre Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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