Hybrid Cardiac Rehabilitation Trial — HYCARET  

Coronary Artery Disease Clinical Trial

Official title: Effectiveness of a Hybrid Cardiac Rehabilitation Program for Coronary Artery Disease Patients. Randomized, Multicenter, Non-inferiority Clinical Trial in a Low-resource Setting. HYCARET Study

Status Completed

Clinical Trial Summary

This clinical trial aim to evaluate if the prevention of recurrent cardiovascular events is not inferior in the hybrid mobile and exercise-based cardiac rehabilitation programs in comparison to the standard cardiac rehabilitation program.

Clinical Trial Description

Background: Cardiac rehabilitation (CR) programs are well established, as their effectiveness and cost-effectiveness is proven. In spite of this, CR remains under-utilized, especially in middle and low-resource settings such as Latin America. As the highest rates of mortality and disability-adjusted life-years in the world are caused by cardiovascular diseases, with a corresponding major impact on economies, there is an urgent need to create more accessible CR delivery models to reach all patients in need. This trial aims to evaluate if the prevention of recurrent cardiovascular events is not inferior in a hybrid cardiac rehabilitation program compared to a standard program.

Method and analysis: A non-inferiority, pragmatic, multicenter, parallel (1:1), single blinded, randomized clinical trial will be conducted. 314 patients with coronary artery disease will be recruited consecutively. Participants will be randomized to hybrid or standard rehabilitation programs. The hybrid CR program includes 10 supervised exercise sessions and individualized lifestyle counseling by a physiotherapist, with a transition after 4-6 weeks to unsupervised delivery via text messages and phone calls. The standard CR consists of 18-22 supervised exercise sessions, as well as group education sessions about lifestyle. The intervention in both groups will be by 12 weeks. The primary outcome is a composite of cardiovascular mortality and hospitalizations due to cardiovascular causes. Secondary outcomes are cardiovascular risk factor control, exercise capacity, adherence to physical activity and diet recommendations, health-related quality of life and exercise-related adverse events. The outcomes will be measured at the end of intervention, at 6 months, and at 12-month follow-up from recruitment. The primary outcome will be tracked through the end of the trial. The sample size was calculated considering 5% of the non-inferiority limit. Per protocol and intention-to-treat analysis will be undertaken. A survival analysis will be run for the primary outcome.

Ethics and dissemination: The corresponding ethical committees at the sponsor institution and each center where participants will be recruited approved the study protocol and the Informed Consent form. Research findings will be published in peer-reviewed journals. Additionally, scientific results will be disseminated among stakeholders and national policy-makers. ;

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

• NCT number: NCT03881150
• Study type: Interventional
• Source: Universidad de La Frontera
• Status: Completed
• Phase: N/A
• Start date: May 6, 2019
• Completion date: May 30, 2022