NCT03059784

Brief Summary

High rates of recurrent cardiovascular events and readmission after percutaneous coronary intervention (PCI) are important issues. Guidelines emphasize rehabilitation and secondary prevention. But many patients are lack of effective management after PCI.This study is aimed to examine the effect of mobile application (APP)-based multifaceted management on the improvement of long-term care after PCI.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,100

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2017

Status
unknown

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

February 17, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 23, 2017

Completed
6 days until next milestone

Study Start

First participant enrolled

March 1, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

February 23, 2017

Status Verified

February 1, 2017

Enrollment Period

1.3 years

First QC Date

February 17, 2017

Last Update Submit

February 20, 2017

Conditions

Percutaneous Coronary Intervention

Outcome Measures

Primary Outcomes (1)

  • evidence-based medication adherence (the proportion of participants taking 3 medications (aspirin, P2Y12 receptor inhibitor, statin) without contraindications)

    the proportion of participants taking 3 medications (aspirin, P2Y12 receptor inhibitor, statin) without contraindications

    at 12 months after PCI

Secondary Outcomes (3)

  • rate of LDL-C achieving target

    at 12 months after PCI

  • rate of systolic blood pressure achieving target

    at 12 months after PCI

  • readmission rate

    12 months after PCI

Other Outcomes (2)

  • smoking status (the proportion of participants with smoking cessation)

    at 12 months after PCI

  • rehabilitation (the proportion of participants who receive rehabilitation program)

    12 months after PCI

Study Arms (2)

intervention

EXPERIMENTAL

APP-based multifaceted management, including sending education material, everyday medication reminder, giving risk factor control support, clinical support to patients after PCI through APP.

Other: APP-based multifaceted management

control

NO INTERVENTION

usual care without APP

Interventions

APP-based multifaceted managementOTHER

Patients after PCI will be regularly given education materials, medication reminders, life-style behaviors instruction through APP. Cardiologists can interact with patients on advice provision and clinical support after discharge through APP.

intervention

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • patients who have received percutaneous coronary intervention and are discharged alive in the study centers;
  • patients who are able to use APP;
  • patients who provide informed consent.

You may not qualify if:

  • patients who are not able to use APP;
  • dementia;
  • mental disturbed;
  • patients who are not willing to receive management and follow up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 1. Levine GN, et al. 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention. Circulation. 2011,124:e574-e651 2. Kolh P, et al. 2014 ESC/EACTS Guidelines on myocardial revascularization. EHJ. 2014,35:2541-2619 3. Chow CK, et al. Effect of Lifestyle-Focused Text Messaging on Risk Factor Modification in Patients With Coronary Heart Disease: A Randomized Clinical Trial. JAMA, 2015, 314:1255-1263 4. Tian M, et al. A Cluster-Randomized, Controlled Trial of a Simplified Multifaceted Management Program for Individuals at High Cardiovascular Risk (SimCard Trial) in Rural Tibet, China, and Haryana, India. Circulation. 2015;132:815-824

    BACKGROUND

Study Officials

  • Yongjian Wu

    Chinese Academy of Medical Sciences, Fuwai Hospital

    STUDY CHAIR

Central Study Contacts

HAIYAN XU

CONTACT

hyxu@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate director of Coronary Artery Disease Center

Study Record Dates

First Submitted

February 17, 2017

First Posted

February 23, 2017

Study Start

March 1, 2017

Primary Completion

July 1, 2018

Study Completion

August 1, 2018

Last Updated

February 23, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will share

management methods,outcomes including medication use, events of patients can be available on request.