AzTrials
AzTrials

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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
What is being tested?
BAMA solution
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

Other trials in China

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.

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 groups in NCT03565978
Study groupRoleWhat they receive
BAMA solutionExperimentalThis 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 careNo interventionNot 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.

  1. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. MACE within 12 months (death, nonfatal myocardial infarction, nonfatal stroke, hospitalization with heart problem, unexpected revascularization)

    Record events and describe

    Measured: 12 months

  7. 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.

  1. First posted21 Jun 2018
  2. Study start8 Apr 2016
  3. Primary completion30 Jul 2018
  4. Study completion30 Jul 2018

Resources

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)
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in