An interventional study of Group- based cardiac telerehabilitation in Coronary Artery Disease, sponsored by University of Eastern Finland. Recruiting at 1 site in Finland. Open to participants aged 18 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-08.
Sponsored by University of Eastern Finland · Not applicable, Interventional, and Treatment
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.
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.
4,857 studies on the registry are indexed under Coronary Artery Disease; 890 are open to participants now.
This study's planned enrollment of 198 is above the median of 124 across 3,006 interventional studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →University of Eastern Finland is the lead sponsor of 54 studies on the registry; 9 are open to participants now.
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Exclusion Criteria:
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
The coronary patient is in primary care under the supervision of a nurse and a doctor.
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.
Also known as: Tulppa- telerehabilitation
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).
Time frame: Baseline and 12 Months
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').
Time frame: Baseline and 12 Months
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').
Time frame: Baseline and 12 Months
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').
Time frame: Baseline and 12 Months
Plan to share: No
No publications or documents are linked to this record.
Started Aug 2023 (actual). Primary completion is estimated for Dec 2025, 28 months after the start.
Of 753 non-industry interventional studies with no phase under Coronary Artery Disease, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 53. This study's planned 28 months is below that.
Counting every sponsor, half of 930 studies reached it within 30 months; a quarter within 15 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
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University of Eastern Finland