Remote medical support system to improve recurrence risk factors in patie nts with ischemic heart disease

JRCT ID: jRCTs042220040

Registered date:07/07/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: acute coronary syndrome, chronic coronary syndrome
• Date of first enrollment: 02/11/2022
• Target sample size: 220
• Study type: Interventional

Intervention(s)

The intervention group receives remote lifestyle intervention using web system for 3 months after baseline lifestyle assessment.
The devices used for lifestyle assessment are list-worn pulse monitor with accelerometer, continuous glucose monitoring sensor, sphygmomanometer, weight scale, and a tablet computer. Patients record blood pressure, pulse rate, and body weight, and answer questionnaires including diet using a tablet.
Web-based lifestyle intervention is delivered after the baseline lifestyle assessment. Lifestyle intervention includes home-based exercise training using a list-worn pulse monitor and individualized diet guidance using a tablet. The data of list-worn pulse monitor and dietary information are stored in the server of the data center at Nagoya University.
Individualized feedback based on lifestyle data and educational materials are provided once every two weeks to encourage behavior change. Short-term goals for physical activity and diet are set once every two weeks.
The lifestyle data is also reported to the outpatient physicians for supporting guideline-oriented medication adjustments to controlling coronary risk factors in necessary.

Outcome(s)

• Primary Outcome: Peak oxygen uptake
• Secondary Outcome: Coronary risk factors: blood pressure (systolic blood pressure, diastolic blood pressure), lipid profile (triglyceride, low-density lipoprotein cholesterol), blood glucose (HbA1c), and body weight, health-related quality of life, moderate to vigorous physical activity, and mean amplitude of glycemic excursions

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both
• Include criteria: Patients underwent percutaneous coronary intervention (PCI) for acute coronary syndrome or chronic coronary syndrome; hope to participate in remote lifestyle intervention after discharge; and are 20 years old or older and provide written informed consent
• Exclude criteria: Patients showing abnormal cardiovascular respons e during electrocardiogram exercise testing; with atrial fibrillation; not capable of using a tablet com puter and IoT device; receiving hemodialysis; considered unsuitable by physicians for participating in remote lifestyle intervention; participating in outpatient cardiac rehabilitation after discharge; not capable of going out alone

Related Information

• Primary Sponsor: Amano Tetsuya
• Secondary Sponsor: Yamada Sumio,Japan Agency for Medical Research and Development