A clinical trial is evaluating the use of a WeChat platform program (WCPP) to improve the management and care of patients with cardiovascular issues. The study, which is being conducted at a large tertiary hospital, aims to assess whether the WCPP can enhance patient outcomes and satisfaction throughout the entire treatment process, from initial consultation to one-year post-discharge.
Trial Design and Intervention
The trial compares a group receiving standard cardiovascular integrated service (CVIS) management with a group receiving CVIS management augmented by the WCPP. The control group undergoes traditional management, including standard treatment and care, which has been clinically validated for safety and efficacy over many years. Patients in this group receive usual treatment and care, including examinations, instructions, education, and communication for surgery, skin preparation, blood work, medication, monitoring, and intravenous antibiotics. Follow-up appointments are scheduled at 1, 3, 6, and 12 months post-discharge. After the research phase, the control group will receive training on how to use the WCPP.
The intervention group receives the same standard treatment and care as the control group, but with the addition of full-process management via the WCPP. This includes guidance and supervision by the trial steer group to ensure quality. The intervention starts in the outpatient clinic or emergency department and continues throughout the hospital stay and up to one year after discharge, with follow-ups at 1, 3, 6, and 12 months. The WCPP is tailored to meet individual patient needs, and patients receive instructions on using the platform's discharge module before leaving the hospital. Researchers maintain contact with patients post-discharge to monitor platform usage.
Outcomes and Measurements
The primary outcome of the trial is the change in quality of life as measured by the Chinese version of the 36-item Short Form Health Survey (SF-36). This scale assesses eight dimensions of health, including physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. Measurements are taken at admission, discharge, and at follow-up points of 1, 3, 6, and 12 months.
Secondary outcomes include:
- 6-minute walk test (6MWT): Measured within 4 hours before discharge and at follow-up points at 1, 3, 6, and 12 months after discharge.
- Modified Barthel Index (MBI): Evaluates activities of daily living (ADL) at admission, discharge, and 1, 3, 6, and 12 months after discharge.
- Major adverse cardiovascular events (MACEs): Including myocardial infarction, severe chest pain, stroke, and heart failure.
- Patient Satisfaction: Measured using a self-designed scale before discharge.
- Length of hospital stay (LOS): Measured in days.
Qualitative data on patient experiences will also be collected through semi-structured interviews to explore their psychological state, overall experience, interactions with healthcare professionals, satisfaction with the WCPP, and intersectoral coordination.
Patient Involvement and Sample Size
The trial incorporates patient-centered care by involving patients in the development of intervention plans through qualitative interviews to prioritize their needs and preferences. Their feedback will be recorded and considered when revising the intervention. The trial process is supervised by research staff from the hospital and medical graduate school to enhance patient participation.
Based on an estimated 50% effect size, 80% power, and a type 1 error of 5%, the sample size calculation indicates that 77 participants are required in each of the intervention and control groups, accounting for an expected 20% dropout rate. Patients are being recruited from the CVIS center of a large tertiary hospital, which handles over 400 CVIS cases annually. The enrollment period may be extended if necessary to achieve the targeted number of participants.
Discontinuation Criteria
Patients may discontinue the study if their condition worsens, if they die, or if they choose to withdraw. Participants can leave the study at any time without consequences. Investigators may also end a patient’s participation if they are uncooperative or do not attend study visits.
