Quality Measurement and Improvement Study of Surgical Coronary Revascularization: Medication Adherence
MISSION-2
1 other identifier
interventional
1,000
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 25, 2015
CompletedFirst Posted
Study publicly available on registry
May 4, 2015
CompletedStudy Start
First participant enrolled
June 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedJune 23, 2015
June 1, 2015
6 months
April 25, 2015
June 21, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (5)
Medication adherence measured by C-MMAC-8
3 month
mortality at 6-month
6 months
mortality at 3-month
3 months
rate of major adverse cardiovascular or cerebral events at 6-month
6 months
rate of major adverse cardiovascular or cerebral events at 3-month
3 months
Other Outcomes (2)
pill count
6 months
pill count
3 month
Study Arms (2)
Intervention group
EXPERIMENTALAPP specific for this study, with reminder, education materials and feedback mechanism for improving secondary medications
Control group
NO INTERVENTIONUsual Care
Interventions
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.
Eligibility Criteria
You may qualify if:
- Underwent coronary artery bypass grafting in 2015
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
China National Center for Cardiovascular Diseases
Beijing, Beijing Municipality, 100037, China
Related Publications (3)
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.
PMID: 24813538BACKGROUNDYu 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.
PMID: 32745732DERIVEDLiu 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.
PMID: 29873315DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Shengshou Hu, MD, PhD
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
- PRINCIPAL INVESTIGATOR
Zhe Zheng, MD, PhD
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
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 25, 2015
First Posted
May 4, 2015
Study Start
June 1, 2015
Primary Completion
December 1, 2015
Study Completion
December 1, 2016
Last Updated
June 23, 2015
Record last verified: 2015-06