NCT03565978

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 3, 2016

Completed
5 days until next milestone

Study Start

First participant enrolled

April 8, 2016

Completed
2.2 years until next milestone

First Posted

Study publicly available on registry

June 21, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2018

Completed
Last Updated

March 5, 2020

Status Verified

March 1, 2020

Enrollment Period

2.3 years

First QC Date

April 3, 2016

Last Update Submit

March 3, 2020

Conditions

ST Segment Elevation Myocardial InfarctionNon-ST Segment Elevation Myocardial InfarctionUnstable Angina

Outcome Measures

Primary Outcomes (1)

  • Compliance for coronary heart disease secondary prevention at 12 months

    Proportion of patients who use standardized secondary prevention medication according to current guidelines.

    12 months

Secondary Outcomes (7)

  • Medication compliance at the 6, 12 months using the MMAS-8 (The eight-item Morisky Medication Adherence Scale)

    6 and 12 months

  • Control rates of risk factors at the 6, 12 months

    6 and 12 months

  • Quality of life at the 6, 12 months (EQ-5D simple score)

    6 and 12 months

  • Quality of life at the 6, 12 months (EQ-5D Visual Analog Score)

    6 and 12 months

  • Quality of life at the 6, 12 month (Seattle angina questionnaire)

    6 and 12 months

  • +2 more secondary outcomes

Study Arms (2)

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.

Device: BAMA solution

Usual care

NO INTERVENTION

Not using the application installed on the tablet. Usual outpatient follow up.

Interventions

BAMA solutionDEVICE

Use of BAMA cardiac post-discharge management solution for patients education and follow up management

BAMA solution

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Cardiology, Peking University First Hospital

Beijing, 100034, China

Location

Related Publications (1)

  • 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.

    PMID: 34906924DERIVED

MeSH Terms

Conditions

ST Elevation Myocardial InfarctionAngina, Unstable

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisAngina PectorisChest PainPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Yong Huo, MD

    Peking University First Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Department of Cardiology

Study Record Dates

First Submitted

April 3, 2016

First Posted

June 21, 2018

Study Start

April 8, 2016

Primary Completion

July 30, 2018

Study Completion

July 30, 2018

Last Updated

March 5, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)