Group-based Cardiac Telerehabilitation and Its Effectiveness

Coronary Artery Disease Clinical Trial

Official title:

Group-based Cardiac Telerehabilitation and Its Effectiveness

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05923580
• Other study ID #: University of Eastern Finland
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: December 1, 2025

Study information

• Verified date: May 2024
• Source: University of Eastern Finland
• Contact: Renuka J Jacobsson, MHSc
• Phone: +358504111741
• Email: renukaj[@]uef.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 198
• Est. completion date: December 1, 2025
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

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.

Locations

Country	Name	City	State
Finland	Renuka Julia Jacobsson	Tuusula	Uusimaa

Sponsors (3)

Lead Sponsor	Collaborator
University of Eastern Finland	Kuopio University Hospital, Oulu University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in The health-related quality of life at 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
Primary	Change from Baseline in The Adherence to Treatment at 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
Primary	Change from Baseline in The Adherence to Medication at 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
Primary	Change from Baseline in Health and Well- being at 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