- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02432469
Quality Measurement and Improvement Study of Surgical Coronary Revascularization: Medication Adherence (MISSION-2)
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Chenfei Rao, MD
- Phone Number: +861088396356
- Email: raochenfeifuwai@126.com
Study Contact Backup
- Name: Junzhe Du, MD
- Phone Number: +8617801013899
- Email: djzlfia@163.com
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100037
- Recruiting
- China National Center for Cardiovascular Diseases
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control group
Usual Care
|
|
Experimental: Intervention group
APP specific for this study, with reminder, education materials and feedback mechanism for improving secondary medications
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Medication adherence measured by Chinese version of the 8-item Morisky medication adherence scale (C-MMAC-8)
Time Frame: 6 months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Medication adherence measured by C-MMAC-8
Time Frame: 3 month
|
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
|
mortality at 6-month
Time Frame: 6 months
|
6 months
|
|
mortality at 3-month
Time Frame: 3 months
|
3 months
|
|
rate of major adverse cardiovascular or cerebral events at 6-month
Time Frame: 6 months
|
composite endpoint of all-cause death, myocardial infraction, stroke and repeat revascularization
|
6 months
|
rate of major adverse cardiovascular or cerebral events at 3-month
Time Frame: 3 months
|
composite endpoint of all-cause death, myocardial infraction, stroke and repeat revascularization
|
3 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
pill count
Time Frame: 6 months
|
the number of tablets remaining divided by the number of tablets prescribed
|
6 months
|
pill count
Time Frame: 3 month
|
the number of tablets remaining divided by the number of tablets prescribed
|
3 month
|
Collaborators and Investigators
Investigators
- 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
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- MOST-2013BAI09B01-3
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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