Medication Adherence Clinical Trial
— MISSION-2Official title:
Quality Measurement and Improvement Study of Surgical Coronary Revascularization: Medication Adherence
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.
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research
Country | Name | City | State |
---|---|---|---|
China | China National Center for Cardiovascular Diseases | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
China National Center for Cardiovascular Diseases |
China,
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
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 |
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