Abstract Body (Do not enter title and authors here): Hypothesis and Purpose:
Cardiac rehabilitation (CR), though markedly beneficial for patients recovering from a cardiovascular (CV) event, procedure, or surgery, is significantly underutilized. We developed a multicomponent and health equity oriented hybrid CR program that combines traditional, center-based CR with home-based CR delivered via technology. In this randomized controlled trial, we hypothesized that hybrid CR would be non-inferior to traditional CR in improving functional status and CV health metrics. This trial was conducted as part of the American Heart Association Health Technologies and Innovation Strategically Focused Research Network.

Study Design and Methods:
Patients were enrolled during or shortly after hospitalization for a CR-eligible event. A run-in phase included two center-based CR sessions followed by randomization in a 1:1 ratio to hybrid CR (intervention) or traditional CR (control) (Figure 1). The hybrid group was offered a technology-enabled, data-driven 12-week coaching and home exercise program (Figure 2) with the option to also attend traditional CR sessions. The control group was referred to a 12-week center-based CR program.

Sample Size:
202

Population Studied:
Adult CR-eligible patients

Intervention:
Hybrid CR

Power Calculations:
To demonstrate non-inferiority with 80% power, assuming a 6-minute walking distance (6MWD) pooled standard deviation of 107 meters (m), a true difference of 30m in favor of the intervention group, and 20% attrition, we aimed to randomize 200 patients (100 per group) to exclude a difference of >12.5m in favor of the control group.

Primary Endpoint:
6MWD at 12 weeks

Secondary Endpoints:
Secondary CV prevention metrics (LDL cholesterol, HgbA1c, blood pressure, weight, physical activity, smoking, diet), CR engagement, and quality of life at 12 weeks

Outcome(s) (Statistical Plan or Main Results):
A total of 202 patients were randomized, whose demographics were similar to eligible and enrolled patients and carried a high burden of cardiovascular risk factors (Table 1). Our statistical plan has been published in JAHA (10.1161/JAHA.123.030654) and the main results will be available for presentation at AHA.24.

Conclusion:
The mTECH-Rehab trial is assessing whether a novel, multicomponent, and health equity oriented hybrid CR program, delivered over 12 weeks, is a safe and effective alternative strategy to traditional CR in improving functional status, CV health metrics, and CR engagement.