Group-based Cardiac Telerehabilitation and Its Effectiveness

May 7, 2024 updated by: University of Eastern Finland
Cardiovascular diseases (CVD) and coronary artery diseases (CAD) are the most common cause of death worldwide. After an acute cardiac event, prevention of new cardiac events is essential and reduces suffering. Group-based cardiac telerehabilitation (CTR) refers to the use of information and communication technologies for rehabilitation purposes in promoting CAD patients´ health.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study aims to assess the group-based cardiac telerehabilitation model and its effectiveness. The data is collected from two University hospitals in Finland. Patients with coronary heart disease two months after percutaneous coronary intervention (N=198) are invited to the study. All the participants are being treated in a healthcare unit that uses digital care pathways for coronary patients. Patients can choose the usual care or group-based cardiac telerehabilitation as follow-up care. All the patients are invited to the study after the chosen follow-up care (telerehabilitation or usual care). Patients will be allocated into two groups: The telerehabilitation group is the intervention group and the usual care group is the control group. Quality of life, adherence to treatment, and lifestyle changes are measured at the baseline and 3, 6, and 12 after the intervention baseline.

Study Type

Interventional

Enrollment (Estimated)

198

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Renuka J Jacobsson, MHSc
  • Phone Number: +358504111741
  • Email: renukaj@uef.fi

Study Contact Backup

Study Locations

  • Finland
    • Uusimaa
      • Tuusula, Uusimaa, Finland, 04300
        • Recruiting
        • Renuka Julia Jacobsson
        • Contact:
          • Renuka Julia Jacobsson
          • Phone Number: 0504111741
          • Email: renukaj@uef.fi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Participants must have patients with coronary heart disease two months after percutaneous coronary intervention.
  • Participants must have ≥18 years of age, and ≤100 years of age
  • Participants are being treated in a healthcare unit that uses digital care pathways for coronary patients.

Exclusion Criteria:

  • Participants must not have coronary artery disease diagnosed.
  • Participants have been in other operations than percutaneous coronary intervention.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Goup-based cardiac telerehabilitation
Group-based cardiac telerehabilitation promotes information, skills, and support for the management of coronary artery disease in coronary patients. The rehabilitation model includes independent familiarization with information content, assignments, and group meetings, as well as the opportunity for a chat and peer support. The intervention is a health professional- lead, and registered rehabilitation model with a start and end.
Behavioral: Group- based cardiac telerehabilitation
Group-based cardiac telerehabilitation promotes information, skills, and support for the management of coronary artery disease in coronary patients. The rehabilitation model includes independent familiarization with information content, assignments, and group meetings, as well as the opportunity for a chat and peer support. The intervention is a health professional- lead, and registered rehabilitation model with a start and end.
Other Names:
  • Tulppa- telerehabilitation
No Intervention: Usual care for cardiac patients
The coronary patient is in primary care under the supervision of a nurse and a doctor.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in The health-related quality of life at 12 Months
Time Frame: Baseline and 12 Months
15D The health-related quality of life (HRQoL) instrument is a generic, comprehensive (15-dimensional), self-administered instrument for adults (age 16+ years). It combines the advantages of a profile and a preference-based, single index measure. A set of utility or preference weights is used to generate the 15D score (single index number) on a 0-1 scale, representing the overall HRQoL (0 = being dead, 0.0162 = being unconscious or comatose, 1 = no problems on any dimension = 'full' HRQOL). Change = (Month 12 score- Baseline score).
Baseline and 12 Months
Change from Baseline in The Adherence to Treatment at 12 Months
Time Frame: Baseline and 12 Months
Adherence to Treatment is a self-assessment instrument designed to describe adherence to treatment of long-term conditions. The questionnaire contains 38 items of adherence to treatment, which are rated on a 5-point Likert scale ('definitely disagree' to 'definitely agree').
Baseline and 12 Months
Change from Baseline in The Adherence to Medication at 12 Months
Time Frame: Baseline and 12 Months
Adherence to Medication- instrument is a generic, self-administered instrument. The questionnaire contains items of adherence to medication, which are rated on a 5-point Likert scale ('definitely disagree' to 'definitely agree').
Baseline and 12 Months
Change from Baseline in Health and Well- being at 12 Months
Time Frame: Baseline and 12 Months
Health and well-being - the instrument is a generic, self-administered instrument. The questionnaire contains items on the factors influencing health and well-being (smoking, use of alcohol, eating habits, physical activity, sleep), which are rated on a 5-point Likert scale ('definitely disagree' to 'definitely agree').
Baseline and 12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Eastern Finland

Collaborators

Oulu University Hospital
Kuopio University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2023

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

June 5, 2023

First Submitted That Met QC Criteria

June 19, 2023

First Posted (Actual)

June 28, 2023

Study Record Updates

Last Update Posted (Actual)

May 8, 2024

Last Update Submitted That Met QC Criteria

May 7, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • University of Eastern Finland

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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