Clinical trial NCT02432469: Quality Measurement and Improvement Study of Surgical Coronary Revascularization: Medication Adherence
Official title: Quality Measurement and Improvement Study of Surgical Coronary Revascularization: Medication Adherence
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Artery Bypass Grafting
Medication Adherence
Mobile Applications
Keywords: coronary artery bypass
medication adherence
secondary prevention
mobile applications
Lead sponsor: China National Center for Cardiovascular Diseases
Sponsor class: OTHER_GOV
First posted: 2015-05-04
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Medication adherence measured by Chinese version of the 8-item Morisky medication adherence scale (C-MMAC-8)
timeFrame: 6 months
Secondary outcomes:
measure: Medication adherence measured by C-MMAC-8
timeFrame: 3 month
measure: mortality at 6-month
timeFrame: 6 months
measure: mortality at 3-month
timeFrame: 3 months
measure: rate of major adverse cardiovascular or cerebral events at 6-month
timeFrame: 6 months
measure: rate of major adverse cardiovascular or cerebral events at 3-month
timeFrame: 3 months
Other outcomes:
measure: pill count
timeFrame: 6 months
measure: pill count
timeFrame: 3 month
Locations:
city: Beijing
country: China
facility: China National Center for Cardiovascular Diseases
state: Beijing
Study officials:
affiliation: State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China
name: Shengshou Hu, MD, PhD
role: STUDY_DIRECTOR
affiliation: State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China
name: Zhe Zheng, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Yu C, Liu C, Du J, Liu H, Zhang H, Zhao Y, Yang L, Li X, Li J, Wang J, Wang H, Liu Z, Rao C, Zheng Z; MISSION-2 Collaborative Group. Smartphone-based application to improve medication adherence in patients after surgical coronary revascularization. Am Heart J. 2020 Oct;228:17-26. doi: 10.1016/j.ahj.2020.06.019. Epub 2020 Jul 4.
citation: Liu CY, Du JZ, Rao CF, Zhang H, Liu HN, Zhao Y, Yang LM, Li X, Li J, Wang J, Wang HS, Liu ZG, Cheng ZY, Zheng Z. Quality Measurement and Improvement Study of Surgical Coronary Revascularization: Medication Adherence (MISSION-2). Chin Med J (Engl). 2018 Jun 20;131(12):1480-1489. doi: 10.4103/0366-6999.233767.