Effectiveness of Artificial Intelligent Based mHealth System to Reduce ACS Patients Bleeding Events After PCI

November 8, 2018 updated by: Yun Dai Chen, Chinese PLA General Hospital

Effectiveness of Artificial Intelligent Based mHealth System(Chronic Disease Management System) to Reduce ACS Patients Bleeding Events After PCI: Parallel Randomized Controlled Trial

The present study was designed to observe the effectiveness of artificial intelligent based mHealth system(Chronic disease management system) to reduce bleeding events in ACS patients undergoing PCI.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

420

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China
        • Recruiting
        • The General Hospital of PLA
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

age≥18 years, male or female; confirmed acute coronary syndrome patients; undergo percutaneous coronary intervention (PCI) treatment; good command of smart phones agree to participate in this clinical study and sign a written consent form.

Exclusion Criteria:

ACS admission deemed secondary to other cause such as traffic accidents, trauma, severe upper gastrointestinal bleeding, surgery, or procedure; patients who are not intend to attend 1 year of follow-up study or investigators find that patients are not able to comply with the study's requirements; pregnant women or lactating women; investigators consider patients who were not suitable for participation with other reasons

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: normal follow-up group
normal follow-up in ACS patients after PCI
Experimental: AI based mHealth system follow-up group
AI based mHealth system follow-up in ACS patients after PCI. ACS patients in this group will receive message to take more notice to bleeding events.
Behavioral: AI based mHealth system
AI based mHealth system is used to deliver self-management contral message and health education message to make patients take notice of bleeding events after PCI.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the incidence of major bleeding during each visit between normal group and smartphone based group
Time Frame: 3 months
Bleeding definition：According to the bleeding Academic Research Congress (BARC) standard
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese PLA General Hospital

Investigators

  • Principal Investigator: Yundai Chen, Master, The General Hospital of PLA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 10, 2018

Primary Completion (Anticipated)

April 1, 2019

Study Completion (Anticipated)

January 1, 2020

Study Registration Dates

First Submitted

November 8, 2018

First Submitted That Met QC Criteria

November 8, 2018

First Posted (Actual)

November 13, 2018

Study Record Updates

Last Update Posted (Actual)

November 13, 2018

Last Update Submitted That Met QC Criteria

November 8, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AI-mHealth-pilot

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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