Implementation and Evaluation of Telemedicine in Cardiac Rehabilitation

NCT ID: NCT06320652

Last Updated: 2025-08-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-02

Study Completion Date

2027-08-31

Brief Summary

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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

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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.

Conditions

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Cardiac Rehabilitation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Cardiac telerehabilitation (video consultation and home monitoring)

Intervention Type 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?).

Interventions

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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?).

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hvidovre University Hospital

OTHER

Sponsor Role collaborator

Copenhagen University Hospital, Hvidovre

OTHER

Sponsor Role lead

Responsible Party

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Nina Cecilie Tjustrup

PhD student, MSc, RN

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Stine M Rosenstroem, Post.doc

Role: PRINCIPAL_INVESTIGATOR

Amager Hvidovre Hospital

Locations

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University Hospital Amager and Hvidovre

Hvidovre, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Nina C Tjustrup, PhD student

Role: CONTACT

+4529213882

Stine M Rosenstroem, Post.doc

Role: CONTACT

+4530277208

Facility Contacts

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Role: primary

References

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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.

Reference Type DERIVED
PMID: 41043840 (View on PubMed)

Other Identifiers

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CUHospital

Identifier Type: -

Identifier Source: org_study_id

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