APP-based Multifaceted Management After PCI

February 20, 2017 updated by: Yongjian Wu, Chinese Academy of Medical Sciences, Fuwai Hospital

Mobile Application-based Multifaceted Management to Improve Long-term Care After Percutaneous Coronary Intervention

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

1100

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 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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: 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.
No Intervention: control
usual care without APP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
evidence-based medication adherence (the proportion of participants taking 3 medications (aspirin, P2Y12 receptor inhibitor, statin) without contraindications)
Time Frame: at 12 months after PCI
the proportion of participants taking 3 medications (aspirin, P2Y12 receptor inhibitor, statin) without contraindications
at 12 months after PCI

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
rate of LDL-C achieving target
Time Frame: at 12 months after PCI
rate of LDL-C achieving target based on guideline
at 12 months after PCI
rate of systolic blood pressure achieving target
Time Frame: at 12 months after PCI
rate of systolic blood pressure achieving target based on guideline
at 12 months after PCI
readmission rate
Time Frame: 12 months after PCI
readmission rate after PCI
12 months after PCI

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
smoking status (the proportion of participants with smoking cessation)
Time Frame: at 12 months after PCI
the proportion of participants with smoking cessation
at 12 months after PCI
rehabilitation (the proportion of participants who receive rehabilitation program)
Time Frame: 12 months after PCI
the proportion of participants who receive rehabilitation program
12 months after PCI

Collaborators and Investigators

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

Sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

Investigators

  • Study Chair: Yongjian Wu, Fuwai Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

March 1, 2017

Primary Completion (Anticipated)

July 1, 2018

Study Completion (Anticipated)

August 1, 2018

Study Registration Dates

First Submitted

February 17, 2017

First Submitted That Met QC Criteria

February 20, 2017

First Posted (Actual)

February 23, 2017

Study Record Updates

Last Update Posted (Actual)

February 23, 2017

Last Update Submitted That Met QC Criteria

February 20, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • 2016-ZX16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

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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