ST Segment Elevation Myocardial InfarctionBAMANCT03565978
Cardiac Care Solution for Coronary Disease Follow up
A study testing BAMA solution in people with ST Segment Elevation Myocardial Infarction and Non-ST Segment Elevation Myocardial Infarction, run by Peking University First Hospital at 1 site in China.
Trial summary
This is a prospective, randomized controlled trial. The aim of the study is to evaluate the impacts of a cardiac post-discharge management solution in the secondary prevention of Coronary Artery Disease (CAD). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- ST Segment Elevation Myocardial Infarction, Non-ST Segment Elevation Myocardial Infarction, Unstable Angina
- What is being tested?
- BAMA solution
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 8 Apr 2016to 30 Jul 2018
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants diagnosed with CAD, including either condition below: once diagnosed with myocardial infarction; or once accepted coronary artery interventional therapy;
- Participants willing to use self-management solution and complying with follow-up plan;
- At point of enrollment, the patients should be at least (>=18) years
- Basic reading skills (Chinese)
Who cannot join
- Participants that are enrolled in another interventional clinical trial
- Participants who refuse to sign informed consent or withdraw for specific reasons recorded
- Participants who have cognition disorder and unable to communicate normally
- Participants who cannot master basic mobile technology skills to operate a mobile application after training
Trial locations and contacts
1 site in 1 country.
China1 site
Division of Cardiology, Peking University First Hospital
Beijing, 100034
About this study
Official title: Evaluation of a Cardiac Care Solution for Post-Hospital Management in Primary and Secondary Care of Patients Diagnosed With Coronary Artery Disease
This is a prospective, randomized controlled trial. The aim of the study is to evaluate the impacts of a cardiac post-discharge management solution in the secondary prevention of Coronary Artery Disease (CAD).
Read the detailed description
The aim of the study is to evaluate the impacts of a cardiac post-discharge management solution in the population of cardiovascular (CVD) patients who were discharged from the hospital. The objectives include two parts:
Objective 1: Assess the feasibilities of using the solution by means of questionnaire.
Objective 2: Evaluate the impacts of the solution in the secondary prevention of Coronary Artery Disease (CAD).
Primary outcome: Compliance of coronary disease secondary prevention at 12 months.
Secondary outcome: Compliance of coronary disease secondary prevention at 6 months. Self-management behavior evaluation at the 6 and 12 months. Medication compliance at 6 and 12 months assessed by self-reporting questionnaire. Control rates of risk factors at the 6 and 12 months (serum LDL-C, blood pressure, fasting serum glucose); quality of life at the 6 and 12 months (EQ-5D, Seattle angina questionnaire); MACE (Major Adverse Cardiac Event) within 12 months (death, nonfatal myocardial infarction, nonfatal stroke, hospitalization for cardiac reason, unplanned coronary revascularization).
The study will be a two arm, randomized control study. The intervention group will use an application installed on a Pad besides standard outpatient follow up, while the control group will receive standard outpatient follow up.
- Conditions
- ST Segment Elevation Myocardial Infarction, Non-ST Segment Elevation Myocardial Infarction, Unstable Angina
- Being tested
- BAMA solution
- Medical subject headings
- ST Elevation Myocardial Infarction, Angina, Unstable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAMA solutionDevice
Use of BAMA cardiac post-discharge management solution for patients education and follow up management
| Study group | Role | What they receive |
|---|---|---|
| BAMA solution | Experimental | This group will use BAMA solution. This is an digital solution used for cardiac post-discharge management. It is an application installed on a tablet. This arm will use this application and also have usual outpatient follow up. Receives: Device: BAMA solution |
| Usual care | No intervention | Not using the application installed on the tablet. Usual outpatient follow up. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance for coronary heart disease secondary prevention at 12 months
Proportion of patients who use standardized secondary prevention medication according to current guidelines.
Measured: 12 months
Secondary outcomes (7)
Medication compliance at the 6, 12 months using the MMAS-8 (The eight-item Morisky Medication Adherence Scale)
The Chinese version MMAS-8, a self-administered rating scale for assessing medication adherence, contains eight items. Each item is measuring a specific behavior and is not a determinant of adherence behavior. Response choices are yes/no for items 1-7 and a 5-point Likert response for the last item. Each response of "no" is rated as "1" and each "yes" is rated as "0" except for Item 5, in which each response of "yes" is rated as "1" and each "no" is rated as "0". For Item 8, responses "0", "1", "2", "3" and "4", are rated as "0", "0.25", "0.75", "0.75" and "1", respectively. The total score on the MMAS-8 can range from 0 to 8, where higher scores indicate higher adherence. The degree of adherence was determined according to the score resulting from the sum of all the correct answers: low adherence (<6 points), medium adherence (6 to <8 points), and high adherence (8 points). In this study, patients were considered adherent when they had a score equal to eight in the MMAS-8.
Measured: 6 and 12 months
Control rates of risk factors at the 6, 12 months
Blood pressure, serum LDL-C level and fast serum glucose
Measured: 6 and 12 months
Quality of life at the 6, 12 months (EQ-5D simple score)
The EQ-5D(EuroQol-5 Dimensions) is an established health-related quality of life instrument, used frequently in both clinical trials and health services research. The EQ-5D instrument classifies respondent's present-day health status in five dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression); each dimension is represented by one question with three severity levels (no problems, some problems and severe problems). Scores for the five dimensions can be converted into a utility index score by applying the scores from preference weights elicited from the UK general population. This calculation produces a value between -0.59 and 1.00, and a value below 0 indicates a worse health condition than death. Higher scores indicate better health status.
Measured: 6 and 12 months
Quality of life at the 6, 12 months (EQ-5D Visual Analog Score)
EQ-5D Visual Analog Score was used in the survey, with anchor points 0 (worst health state) and 100 (best health state). The scale consisted of a horizontal line where every 10th was marked and labelled 0, 10, 20,…, 100. The question was framed: "On the scale please point out which point best represents your own health state today."
Measured: 6 and 12 months
Quality of life at the 6, 12 month (Seattle angina questionnaire)
The Seattle Angina Questionnaire (SAQ), a 19-item index, is a commonly used disease-specific instrument for assessing symptoms and their impact on daily life with CAD. SAQ comprises five domains: physical limitation (PL), anginal stability (AS), anginal frequency (AF), treatment satisfaction (TS), and the disease perception (DP). SAQ is scored by assigning each response an ordinary value, from 1 (the lowest level of functioning) to 10 (the highest level of functioning), and summing across items within each of the 5 dimensional scales. Scale scores are then transformed to a scale of 0 to 100 by subtracting the lowest possible scale score, dividing the remainder by the range of the scale, and multiplying that by 100. Higher scores on SAQ subscales indicate higher levels of functioning/satisfaction and fewer limitations. The Chinese version of SAQ has been shown to be a valid, responsive, and reliable instrument and has been used in clinical trials.
Measured: 6 and 12 months
MACE within 12 months (death, nonfatal myocardial infarction, nonfatal stroke, hospitalization with heart problem, unexpected revascularization)
Record events and describe
Measured: 12 months
Self-management behaviors evaluation at the 6, 12 months using a local questionnaire
The Coronary Heart Disease Self-Management Behavior Scale used the Likert 5-point scale method to investigate patients' self-management behavior over the past 3 months. This scale has been widely used in China for self-management behavior of patients with coronary heart disease. The measurement has a good reliability and validity. The scale has three dimensions: (1) The dimensions of daily management, including management of general life and bad habits; (2) The dimension of emotion management is the emotional cognition management; (3)The dimensions of medical management include management of symptom, first-aid, disease knowledge and treatment adherence. The scores of the items in each dimension add up and transform to represent the total score of the dimension; the sum of the dimension scores represents the total score of self-management behavior, which range from 0 to 100. The higher the score that patient had indicates the better self-management behavior.
Measured: 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2018
- Study start8 Apr 2016
- Primary completion30 Jul 2018
- Study completion30 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ST Segment Elevation Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Peking University First HospitalThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Philips Clinical & Medical Affairs Global
- Responsible party
- Principal investigator, Yong Huo, Peking University First Hospital
- Investigators
- Yong Huo, MD, Principal investigator, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03565978
- Sponsor's protocol ID
- BAMA 0.1
- Acronym
- BAMA
- Status last verified
- Mar 2020
- First submitted
- 3 Apr 2016
- Last updated
- 5 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Li Y, Gong Y, Zheng B, Fan F, Yi T, Zheng Y, He P, Fang J, Jia J, Zhu Q, Jiang J, Huo Y. Effects on Adherence to a Mobile App-Based Self-management Digital Therapeutics Among Patients With Coronary Heart Disease: Pilot Randomized Controlled Trial. JMIR Mhealth Uhealth. 2022 Feb 15;10(2):e32251. doi: 10.2196/32251.
PubMed 34906924
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Cardiac Care Solution for Post-Hospital Management in Primary and Secondary Care of Patients Diagnosed With Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT03565978
- Acronym / sponsor ID
- BAMA / BAMA 0.1
- Conditions
- ST Segment Elevation Myocardial Infarction, Non-ST Segment Elevation Myocardial Infarction, Unstable Angina
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Collaborators
- Philips Clinical & Medical Affairs Global
- Study start
- 8 Apr 2016 (actual)
- Primary completion
- 30 Jul 2018 (actual)
- Study completion
- 30 Jul 2018 (actual)
- First posted
- 21 Jun 2018 (actual)
- 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.
This is a prospective, randomized controlled trial. The aim of the study is to evaluate the impacts of a cardiac post-discharge management solution in the secondary prevention of Coronary Artery Disease (CAD).
Detailed description
The aim of the study is to evaluate the impacts of a cardiac post-discharge management solution in the population of cardiovascular (CVD) patients who were discharged from the hospital. The objectives include two parts:
Objective 1: Assess the feasibilities of using the solution by means of questionnaire.
Objective 2: Evaluate the impacts of the solution in the secondary prevention of Coronary Artery Disease (CAD).
Primary outcome: Compliance of coronary disease secondary prevention at 12 months.
Secondary outcome: Compliance of coronary disease secondary prevention at 6 months. Self-management behavior evaluation at the 6 and 12 months. Medication compliance at 6 and 12 months assessed by self-reporting questionnaire. Control rates of risk factors at the 6 and 12 months (serum LDL-C, blood pressure, fasting serum glucose); quality of life at the 6 and 12 months (EQ-5D, Seattle angina questionnaire); MACE (Major Adverse Cardiac Event) within 12 months (death, nonfatal myocardial infarction, nonfatal stroke, hospitalization for cardiac reason, unplanned coronary revascularization).
The study will be a two arm, randomized control study. The intervention group will use an application installed on a Pad besides standard outpatient follow up, while the control group will receive standard outpatient follow up.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BAMA solution | Experimental | Device: BAMA solutionThis group will use BAMA solution. This is an digital solution used for cardiac post-discharge management. It is an application installed on a tablet. This arm will use this application and also have usual outpatient follow up. |
| Usual care | No intervention | –Not using the application installed on the tablet. Usual outpatient follow up. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants diagnosed with CAD, including either condition below: once diagnosed with myocardial infarction; or once accepted coronary artery interventional therapy;
- Participants willing to use self-management solution and complying with follow-up plan;
- At point of enrollment, the patients should be at least (>=18) years
- Basic reading skills (Chinese)
Key exclusion criteria (4 listed)
- Participants that are enrolled in another interventional clinical trial
- Participants who refuse to sign informed consent or withdraw for specific reasons recorded
- Participants who have cognition disorder and unable to communicate normally
- Participants who cannot master basic mobile technology skills to operate a mobile application after training
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 |
|---|---|---|
| BAMA solutionUse of BAMA cardiac post-discharge management solution for patients education and follow up management | Device | BAMA solution |
Primary outcome
Compliance for coronary heart disease secondary prevention at 12 months
Time frame: 12 months
Proportion of patients who use standardized secondary prevention medication according to current guidelines.
7 secondary outcomes
Medication compliance at the 6, 12 months using the MMAS-8 (The eight-item Morisky Medication Adherence Scale)
Time frame: 6 and 12 months
Control rates of risk factors at the 6, 12 months
Time frame: 6 and 12 months
Quality of life at the 6, 12 months (EQ-5D simple score)
Time frame: 6 and 12 months
Quality of life at the 6, 12 months (EQ-5D Visual Analog Score)
Time frame: 6 and 12 months
Quality of life at the 6, 12 month (Seattle angina questionnaire)
Time frame: 6 and 12 months
MACE within 12 months (death, nonfatal myocardial infarction, nonfatal stroke, hospitalization with heart problem, unexpected revascularization)
Time frame: 12 months
Self-management behaviors evaluation at the 6, 12 months using a local questionnaire
Time frame: 6 and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2020.
- Derived from this study: PubMed 34906924Li Y, Gong Y, Zheng B, Fan F, Yi T, Zheng Y, He P, Fang J, Jia J, Zhu Q, Jiang J, Huo Y. Effects on Adherence to a Mobile App-Based Self-management Digital Therapeutics Among Patients With Coronary Heart Disease: Pilot Randomized Controlled Trial. JMIR Mhealth Uhealth. 2022 Feb 15;10(2):e32251. doi: 10.2196/32251.
- Individual participant dataSharing planned: No
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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.
Yong Huo, MD principal investigator
Peking University First Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BAMA solution in people with ST Segment Elevation Myocardial Infarction and Non-ST Segment Elevation Myocardial Infarction, run by Peking University First Hospital 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 5 Mar 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compliance for coronary heart disease secondary prevention at 12 months (time frame: 12 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 NCT03565978, which also lists 1 linked publication.
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 5 Mar 2020; AzTrials last refreshed its copy on 6 Nov 2026.