APP-based Multifaceted Management After PCI

NCT ID: NCT03059784

Last Updated: 2017-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

1100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-31

Study Completion Date

2018-08-31

Brief Summary

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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.

Detailed Description

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This is a cluster-randomized controlled trial to evaluate the effect of APP-based multifaceted management strategy on improvement of long-term care for medication adherence,risk factor control, and reduction of adverse events, readmission rate and mortality after PCI.It includes knowledge education, medication reminder,advice provision, support to change lifestyle behaviors. The program is interactive between care provider and patients. A total of 20 wards will be randomly assigned to intervention or usual care.Anticipated 1100 patients after PCI will be participated in the trial. All the participants will be followed up until 12 months.

Conditions

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Percutaneous Coronary Intervention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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intervention

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

Group Type EXPERIMENTAL

APP-based multifaceted management

Intervention Type OTHER

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.

control

usual care without APP

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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APP-based multifaceted management

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 Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

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

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese Academy of Medical Sciences, Fuwai Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yongjian Wu

Associate director of Coronary Artery Disease Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yongjian Wu

Role: STUDY_CHAIR

Chinese Academy of Medical Sciences, Fuwai Hospital

Central Contacts

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HAIYAN XU

Role: CONTACT

References

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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

Reference Type BACKGROUND

Other Identifiers

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2016-ZX16

Identifier Type: -

Identifier Source: org_study_id

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