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

Medication Adherence Clinical Trial

— MISSION-2  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02432469
• Other study ID #: MOST-2013BAI09B01-3
• Status: Recruiting
• Phase: N/A
• First received: April 25, 2015
• Last updated: June 21, 2015
• Start date: June 2015
• Est. completion date: December 2016

Study information

• Verified date: June 2015
• Source: China National Center for Cardiovascular Diseases
• Contact: Chenfei Rao, MD
• Phone: +861088396356
• Email: raochenfeifuwai[@]126.com
• Is FDA regulated: No
• Health authority: China: Ministry of Science and Technology
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Underwent coronary artery bypass grafting in 2015

Exclusion Criteria:

• Does not use a smartphone

• Can not install the study specific APP into his/her smartphone

• Does not use 3 or more applications installed in his/her smartphone

• Is incapable to understand texts in Chinese

• Can not type numbers in his/her smartphone

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

Intervention

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

Locations

Country	Name	City	State
China	China National Center for Cardiovascular Diseases	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
China National Center for Cardiovascular Diseases

Country where clinical trial is conducted

China, 

References & Publications (1)

Yan J, You LM, Yang Q, Liu B, Jin S, Zhou J, Lin C, Morisky DE. Translation and validation of a Chinese version of the 8-item Morisky medication adherence scale in myocardial infarction patients. J Eval Clin Pract. 2014 Aug;20(4):311-7. doi: 10.1111/jep.12125. Epub 2014 May 10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	pill count	the number of tablets remaining divided by the number of tablets prescribed	6 months	No
Other	pill count	the number of tablets remaining divided by the number of tablets prescribed	3 month	No
Primary	Medication adherence measured by Chinese version of the 8-item Morisky medication adherence scale (C-MMAC-8)	patients' medication adherence measured by C-MMAC-8 at 6-month after randomization, the scale of more than 7 is defined as adherence to medications	6 months	No
Secondary	Medication adherence measured by C-MMAC-8	patients' medication adherence measured by C-MMAC-8 at 3-month after randomization, the scale of more than 7 is defined as adherence to medications	3 month	No
Secondary	mortality at 6-month		6 months	Yes
Secondary	mortality at 3-month		3 months	Yes
Secondary	rate of major adverse cardiovascular or cerebral events at 6-month	composite endpoint of all-cause death, myocardial infraction, stroke and repeat revascularization	6 months	Yes
Secondary	rate of major adverse cardiovascular or cerebral events at 3-month	composite endpoint of all-cause death, myocardial infraction, stroke and repeat revascularization	3 months	Yes