Quality Measurement and Improvement Study of Surgical Coronary Revascularization: Medication Adherence — MISSION-2  

Medication Adherence Clinical Trial

Official title: Quality Measurement and Improvement Study of Surgical Coronary Revascularization: Medication Adherence

Status Recruiting

Clinical Trial Summary

The study is a randomized controlled trial, having a plan to recruit 1000 patients underwent coronary artery bypass grafting in 1 of 5 participating sites in 2015, and randomized to either the intervention group or control group, to test the effectiveness of a smartphone based application (APP) focusing on improving patients medication adherence. Patients randomized to the intervention group install the APP in their smartphones with personnel information and physicians' medication descriptions. The APP reminds at the time of taking medications, educates them on secondary prevention for coronary artery disease, and collects their weekly situations by questionaires. Investigators will follow-up patients by face to face or telephone interview. The 6-month effects of the intervention are evaluated.

Clinical Trial Description

The aim of this study is to test the effectiveness of a smartphone based application (APP) on improvement of patients' adherence to medications after coronary artery bypass grafting.

DESIGN AND PROCEDURES The study is a randomized controlled trial, having a plan to recruit 1000 patients underwent coronary artery bypass grafting in 2015, and randomized to either the intervention group or the control group, to test the effectiveness of a smartphone based APP focusing on improving patients medication adherence. Patients randomized to the intervention group install the APP and are intervened by it. The patients randomized to control group receive usual care. The investigators follow up patients in both groups by face to face or telephone interview at 3-month and 6-month after randomization. The 6-month effects of the intervention are evaluated.

The APP contains education materials about secondary prevention of coronary artery disease, patients can surf and read easily. The APP also collects information on medication prescription by doctors, reminds patients at every time of taking medications, and asks for feedback at 8 pm everyday. The APP also pushes one patient-specific questionnaire with 10-15 questions weekly, to collect information about patients' medication adherence and self-administration on blood pressure, blood lipid, glucose, physical activity, diet and body weight. APP will push series of recommendations right after patients' finishing the questionnaire to help them improve secondary prevention.

The coordinators from participating sites interview patients at the baseline, 3-month and 6-month after the randomization, for information of medication adherence, major events and outcomes after coronary artery bypass grafting and quality of life. The primary outcome measure is the Chinese version of the 8-item Morisky medication adherence scale which has already been validated in Chinese population. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Coronary Artery Bypass Grafting
• Medication Adherence
• Mobile Applications

• NCT number: NCT02432469
• Study type: Interventional
• Source: China National Center for Cardiovascular Diseases
• Contact: Chenfei Rao, MD
• Phone: +861088396356
• Email: raochenfeifuwai@126.com
• Status: Recruiting
• Phase: N/A
• Start date: June 2015
• Completion date: December 2016