Implementation and Evaluation of Telemedicine in Cardiac Rehabilitation

NCT06320652 | Recruiting

• 1 other identifier: CUHospital
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Rehabilitation

Keywords

Cardiac rehabilitation; Telemedicine; Video consultation; Home monitoring

Outcome Measures

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.

  3 months

Secondary Outcomes (3)

• The European Quality of life five dimensions questionnaire

  3 months

• The Iceland-Family Perceived Support Questionnaire

  3 months

• The eHealth Literacy Questionnaire

  3 months

Study Arms (2)

Standard care

NO INTERVENTION

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.

Cardiac Telerehabilitation

EXPERIMENTAL

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

Cardiac telerehabilitation (video consultation and home monitoring) OTHER

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?).

Cardiac Telerehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Copenhagen University Hospital, Hvidovre: lead
• Hvidovre University Hospital: collaborator

Study Sites (1)

University Hospital Amager and Hvidovre

Hvidovre, 2650, Denmark

RECRUITING

Related Publications (2)

• 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.

  PMID: 41559760 DERIVED

• 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.

  PMID: 41043840 DERIVED

Study Officials

• Stine M Rosenstroem, Post.doc

  Amager Hvidovre Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nina C Tjustrup, PhD student

CONTACT

+4529213882; nina.cecilie.tjustrup@regionh.dk

Stine M Rosenstroem, Post.doc

CONTACT

+4530277208; stine.maria.rosenstroem@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD student, MSc, RN

Model Details: 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.

Study Record Dates

• First Submitted: March 11, 2024
• First Posted: March 20, 2024
• Study Start: May 2, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): August 31, 2027
• Last Updated: August 5, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)