Clinical trial NCT05923580: Group-based Cardiac Telerehabilitation and Its Effectiveness
Official title: Group-based Cardiac Telerehabilitation and Its Effectiveness
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Coronary artery disease
Cardiac telerehabilitation
Quality of life
Adherence to treatment
Lifestyle change
Lead sponsor: University of Eastern Finland
Sponsor class: OTHER
Collaborators: name: Oulu University Hospital
name: Kuopio University Hospital
First posted: 2023-06-28
Enrollment: 198
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants' quality of life (measured with the 15D quality of life instrument), lifestyle changes, and adherence to treatment will be measured using quantitative methods with a quasi-experimental research design and interrupted time- series design. The power analysis for the study will be conducted using Finnish population norms for the 15D instrument. The sample size will be 198 cardiac rehabilitation participants (N=198), with 99 participants in the intervention group (N=99) and 99 participants in the control group (N=99). With this sample size, a power of over 80% (p=0.05) will be achieved to detect a difference of 0.12 (0.95 vs. 0.83, SD=0.3) in quality of life between the groups.
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from Baseline in The health-related quality of life at 12 Months
timeFrame: Baseline and 12 Months
measure: Change from Baseline in The Adherence to Treatment at 12 Months
timeFrame: Baseline and 12 Months
measure: Change from Baseline in The Adherence to Medication at 12 Months
timeFrame: Baseline and 12 Months
measure: Change from Baseline in Health and Well- being at 12 Months
timeFrame: Baseline and 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Tuusula
country: Finland
facility: Renuka Julia Jacobsson
state: Uusimaa
Study officials:
References: