Effect of a patient health engagement (PHE) model on rehabilitation participation in patients with acute myocardial infarction after PCI: a study protocol for a randomized controlled trial.

Abstract

Background: Participation in cardiac rehabilitation is low in patients with acute myocardial infarction (AMI) after percutaneous coronary intervention (PCI). Although existing rehabilitation methods have achieved certain results, patient participation in exercise rehabilitation is not ideal. The Patient Health Engagement (PHE) model is designed to ensure that patients improve their participation in cognitive, emotional, behavioral, and other aspects in all phases of exercise rehabilitation. The purpose of this study is to confirm whether the rehabilitation method based on the PHE model improves the rate of patient participation and enhances the rehabilitation effect during cardiac rehabilitation in patients with acute myocardial infarction compared with the traditional rehabilitation model.

Methods/design: This is a single-center, double-blind, randomized, controlled trial that will enroll 128 patients. Patients with stable acute myocardial infarction after undergoing PCI who received cardiac rehabilitation and postoperative LVEF ≥ 40%, categorized into Killip class I ~ II and with age ≥ 18 years, will be included in the study. Exclusion criteria are mainly malignant arrhythmias, acute heart failure, congestive heart failure, and patients requiring intra-aortic balloon counterpulsation. Patients will be randomized in a 1:1 ratio to the intervention (1) and control (2) groups. Physicians, rehabilitation specialists, patients, and data collectors will be blinded during the study. A rehabilitator and a specialist nurse will conduct the cardiac rehabilitation. The specialist nurse will hand over the sealed bag containing patient information (group 1 or 2) to the physician. Group 1 will undergo cardiac rehabilitation through the PHE model, three times a week for 3 months. The rehabilitation program will be evaluated and adjusted in time from each period of the rehabilitation. Group 2 will be treated with routine cardiac rehabilitation. The rehabilitation participation rate of the two groups will be evaluated before and after 3 months of intervention. The primary outcome will be the level of patient participation in rehabilitation, and the secondary outcome will include general data of patients, postoperative rehabilitation indicators, cardiac rehabilitation knowledge-attitude-practice questionnaire, cardiovascular adverse events, and a brief mood scale.

Expected outcomes: We expect improved cardiac rehabilitation participation rates and rehabilitation outcomes in patients with acute myocardial infarction after undergoing PCI using the PHE model.

Discussion: This approach may increase patient participation in rehabilitation, improve rehabilitation outcomes, and be widely implemented in hospitals and rehabilitation centers.

Trial registration: ClinicalTrials.gov identifier, ChiCTR2400085276 (Version 2.0 June 04, 2024),  https://www.chictr.org.cn .

Trial sponsor: Shandong Second Medical university, Weifang, Shandong. Contact name: Dechun Qin, Address: Shandong Second Medical university, Weifang Shandong. Email: 13562666589@163.com.