Trial results for the iCARE (Improving Cardiac Rehabilitation Outcomes Through Mobile Case Management) study were posted on ClinicalTrials.gov on 2026-04-27. This study, which enrolled 206 participants, investigated various approaches to cardiac rehabilitation for conditions including Heart Failure, Acute Myocardial Infarction, Acute Coronary Syndrome, Stable Angina Pectoris, and Percutaneous Coronary Intervention.
Background
Cardiac rehabilitation is crucial for patients with heart conditions, but adherence can be challenging. Mobile health (mHealth) interventions offer a potential solution to improve access and engagement by providing flexible, home-based, or hybrid care models. The iCARE study aimed to compare conventional center-based cardiac rehabilitation with mHealth-supported approaches.
Trial design
This completed Phase NA study enrolled 206 participants with conditions such as Acute Myocardial Infarction, Acute Coronary Syndrome, Stable Angina Pectoris, Percutaneous Coronary Intervention, and Heart Failure. The trial compared Conventional Center-Based Cardiac Rehab (CON) with two mHealth-integrated arms: Conventional Center-Based Cardiac Rehab + mHealth (CON+) and Home-Based Cardiac Rehab + mHealth (HOM+). The study's objective was to assess if home-based or hybrid rehab models were as effective as clinic-based care. Primary outcome details were not provided.
Key results
The trial reported several key measurements across the different intervention groups:
- Change in Metabolic Equivalents of Task (METS):
- Participants in the Conventional Center-Based Cardiac Rehab (CON) group showed a median change of 6.48 mL/kg/min.
- The Conventional Center-Based Cardiac Rehab + mHealth (CON+) group showed a median change of 7.40 mL/kg/min.
- The Home-Based Cardiac Rehab + mHealth (HOM+) group showed a median change of 7.43 mL/kg/min.
- Number of Participants Who Were Re-hospitalized During the Trial:
- In the CON group, 19 participants were re-hospitalized.
- In the CON+ group, 26 participants were re-hospitalized.
- In the HOM+ group, 11 participants were re-hospitalized.
- Adherence to the Intervention:
- The CON group had a median adherence of 66.7 percentage of completed visits.
- The CON+ group had a median adherence of 88.0 percentage of completed visits.
- The HOM+ group achieved a median adherence of 100 percentage of completed visits.
- Change in Body Mass Index:
- The CON group had a median BMI of 29.1 kg/m^2.
- The CON+ group had a median BMI of 29.5 kg/m^2.
- The HOM+ group had a median BMI of 28.5 kg/m^2.
What this means
The iCARE study results indicate that integrating mHealth into cardiac rehabilitation can significantly improve patient adherence, with median rates of 88.0% for CON+ and 100% for HOM+ compared to 66.7% for CON. Both mHealth-supported groups also showed higher median improvements in Metabolic Equivalents of Task (METS). Notably, the home-based mHealth group (HOM+) reported the lowest number of re-hospitalized participants. These findings suggest mHealth can enhance engagement and potentially clinical outcomes in cardiac rehabilitation, offering more accessible options for patients.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT04938661, titled "Improving Cardiac Rehabilitation Outcomes Through Mobile Case Management (iCARE)", were posted on 2026-04-27 on clinicaltrials.gov.