Rationale and design of the TeleClinical Care Cardiac (TCC-Cardiac) trial: A pragmatic randomized trial of adjunctive virtual models of care in the secondary prevention of cardiovascular events

BACKGROUND: Digital health interventions have potential to improve outcomes in high risk cardiac patients through remote monitoring and patient education but introduce accessibility issues among patients who lack suitable smartphones. We will evaluate the effectiveness and scalability of the TeleClinical Care Cardiac (TCCCardiac) platform, that aims to reduce hospital readmissions and improve adherence to care. METHODS: A pragmatic, all-comers trial with nested randomization, where patients being discharged home following an admission with acute myocardial infarction (MI) or decompensated heart failure (HF) are divided into 3 cohorts pragmatically, based on their access to technology. Cohort 1 participants are randomized to either the TCCCardiac model of care or usual care alone. The intervention includes a smartphone app, blood pressure monitor, weight scales, and a pulse oximeter, with remote monitoring of daily inputs by clinicians. Cohort 2 participants, with incompatible mobile phones, are randomized to receive educational content by SMS (TCC-Text) or usual care alone. Cohort 3 participants with no mobile phone receive usual care alone. The primary objective is to compare six-month readmission rates (primary end point) in Cohort 1. Secondary objectives include comparing the primary end point, evaluating the cost-effectiveness and overall impact across all cohorts and interventions, and process evaluation to understand the reach, adoption, and effectiveness of the full intervention. Follow-up includes 6-month interview for Cohort 1 and data linkage for all cohorts for 12-month outcomes. RESULTS: The trial began in July 2021. Recruitment was slower than expected due to delays and interruptions related to COVID-19 and the final enrolment date was set for October 2023, by which time 873 participants had been enrolled: 553 in Cohort 1 (63.3%), 161 in Cohort 2 (18.4%), and 159 in Cohort 3 (18.2%). Data linkage is anticipated in May 2025, which includes a 6-month delay to ensure 12-month data will be available for all study patients, followed by the analysis of results. CONCLUSIONS: TCCCardiac is the first large-scale study to assess smartphone-based messaging and remote monitoring in high-risk cardiac patients post-hospitalization. The study's pragmatic design and process evaluation aim to enhance future implementation. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry Number ACTRN12621000754842.