Coronary Artery Bypass GraftingMISSION-2NCT02432469
Quality Measurement and Improvement Study of Surgical Coronary Revascularization: Medication Adherence
A study testing APP intervention in people with Coronary Artery Bypass Grafting and Medication Adherence, run by China National Center for Cardiovascular Diseases at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Bypass Grafting, Medication Adherence, Mobile Applications
- What is being tested?
- APP intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- Jun 2015to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Underwent coronary artery bypass grafting in 2015
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
China National Center for Cardiovascular Diseases
Beijing, Beijing Municipality, 100037
Zhe Zheng, M.D., Ph.D., 8610-8839-6051, zhengzhefuwai@tom.com
Zhe Zheng, M.D., Ph.D.
About this study
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.
Read the 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.
- Being tested
- APP intervention
- Keywords
- coronary artery bypass, medication adherence, secondary prevention, mobile applications
- Medical subject headings
- Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APP interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | APP specific for this study, with reminder, education materials and feedback mechanism for improving secondary medications Receives: Behavioral: APP intervention |
| Control group | No intervention | Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (5)
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
Measured: 3 month
mortality at 6-month
Measured: 6 months
mortality at 3-month
Measured: 3 months
rate of major adverse cardiovascular or cerebral events at 6-month
composite endpoint of all-cause death, myocardial infraction, stroke and repeat revascularization
Measured: 6 months
rate of major adverse cardiovascular or cerebral events at 3-month
composite endpoint of all-cause death, myocardial infraction, stroke and repeat revascularization
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2015 (estimated)
- Study startJun 2015
- Primary completionDec 2015 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery Bypass GraftingStudies of the same condition, open and under way.
- More trials run by China National Center for Cardiovascular DiseasesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Shengshou Hu, MD, PhD, Study director, 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 ChinaZhe Zheng, MD, PhD, Principal investigator, 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02432469
- Sponsor's protocol ID
- MOST-2013BAI09B01-3
- Acronym
- MISSION-2
- Status last verified
- Jun 2015
- First submitted
- 25 Apr 2015
- Last updated
- 23 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 24813538Yu 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.
PubMed 32745732Liu 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.
PubMed 29873315
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality Measurement and Improvement Study of Surgical Coronary Revascularization: Medication Adherence
- ClinicalTrials.gov ID
- NCT02432469
- Acronym / sponsor ID
- MISSION-2 / MOST-2013BAI09B01-3
- Keywords
- coronary artery bypass, medication adherence, secondary prevention, mobile applications
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Study start
- Jun 2015
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 4 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: APP interventionAPP specific for this study, with reminder, education materials and feedback mechanism for improving secondary medications |
| Control group | No intervention | –Usual Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Underwent coronary artery bypass grafting in 2015
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| APP interventionThe 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. | Behavioural | Intervention group |
Primary outcome
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
5 secondary outcomes
Medication adherence measured by C-MMAC-8
Time frame: 3 month
mortality at 6-month
Time frame: 6 months
mortality at 3-month
Time frame: 3 months
rate of major adverse cardiovascular or cerebral events at 6-month
Time frame: 6 months
rate of major adverse cardiovascular or cerebral events at 3-month
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2015.
- Background: PubMed 24813538Yan 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.
- Derived from this study: PubMed 32745732Yu 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.
- Derived from this study: PubMed 29873315Liu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shengshou Hu, MD, PhD study director
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
Zhe Zheng, MD, PhD principal investigator
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing APP intervention in people with Coronary Artery Bypass Grafting and Medication Adherence, run by China National Center for Cardiovascular Diseases at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chenfei Rao, MD (+861088396356, raochenfeifuwai@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medication adherence measured by Chinese version of the 8-item Morisky medication adherence scale (C-MMAC-8) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02432469, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2015.