A randomized, controlled trial is currently underway at the Cardiac Rehabilitation Center of Weifang People’s Hospital to evaluate the effectiveness of a Patient Health Engagement (PHE) model on improving rehabilitation participation among patients who have experienced Acute Myocardial Infarction (AMI) and undergone Percutaneous Coronary Intervention (PCI). The study, registered in the Chinese Clinical Trial Registry (ChiCTR2400085276), adheres to the Declaration of Helsinki and aims to address the need for enhanced patient engagement in cardiac rehabilitation programs.
Study Design and Patient Population
The trial employs a randomized, parallel-controlled, observer-patient double-blind, single-center superiority design. A total of 128 patients will be recruited and randomized in a 1:1 ratio to either the intervention group, receiving a cardiac rehabilitation program based on the PHE model, or the control group, receiving routine cardiac rehabilitation. Inclusion criteria include patients aged 18-80 years with a left ventricular ejection fraction (LVEF) ≥ 40%, Killip Class I-II, heart rate between 55-100 beats/min, systolic blood pressure between 90-140 mmHg, diastolic blood pressure between 60-90 mmHg, intact lower limb function, stable post-PCI condition, and voluntary informed consent. Exclusion criteria encompass patients requiring aortic balloon counterpulsation, those with severe disturbance of consciousness, serious complications like malignant arrhythmia or acute heart failure, chronic diseases impairing self-care, and refusal to cooperate with exercise rehabilitation.
Intervention and Blinding
The intervention group will participate in a PHE model-based cardiac rehabilitation program, which involves assessing the patient's current PHE stage (blackout, arousal, attachment, or eudaimonic project) using the CPHE-s scale and providing tailored rehabilitation treatment plans accordingly. Patients are evaluated monthly to assess their PHE stage, with targeted interventions adjusted based on their progress. The control group receives routine cardiac rehabilitation, including aerobic and resistance exercise, drug treatment, dietary counseling, and health education, based on clinical guidelines. To minimize bias, patients, doctors, and nurses are blinded to the allocation. Researchers are prohibited from informing patients of their allocation status during the evaluation phase. Group 1 attends rehabilitation in the morning, and group 2 attends rehabilitation in the afternoon.
Endpoints and Data Collection
The primary endpoint is patient participation in rehabilitation, measured using the CPHE-s scale at months 1, 2, and 3 (t1, t2, and t3). Secondary endpoints include postoperative rehabilitation indicators (myocardial enzyme examination and hospitalization time), cognitive effects of cardiac rehabilitation assessed via a cardiac rehabilitation KAP questionnaire, occurrence of cardiovascular adverse events, and changes in psychological state measured by the Profile of Mood States (POMS). Baseline data collected includes demographic information, disease-related data (Killip classification, infarct location, medication type, BMI, vascular status), and lifestyle factors (exercise frequency, sleep status, smoking history, alcohol consumption history).
Safety Measures and Monitoring
Patients are continuously monitored using dynamic electrocardiogram and blood oxygen/pressure monitors. The intervention is promptly adjusted or terminated if patients experience chest tightness, pale complexion, dizziness, or ataxia. Nitroglycerin and other drugs are administered for symptomatic treatment as needed. A data and safety monitoring committee oversees data collection and compilation, as well as the occurrence and treatment of adverse reactions. The research team meets monthly to discuss progress and address any issues, with the hospital ethics committee conducting periodic reviews to ensure compliance with regulations.
