APP-based Multifaceted Management After PCI

Not Applicable

• Conditions: Percutaneous Coronary Intervention
• Interventions: Other: APP-based multifaceted management

• Registration Number: NCT03059784
• Lead Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital

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.

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 Timeline

• Status Verified: 2017-02
• Study First Submitted: 2017-02-17
• Study First Submitted QC: 2017-02-20
• Last Update Submitted: 2017-02-20
• Study First Posted: 2017-02-23
• Last Update Posted: 2017-02-23
• Study Start: 2017-03
• Primary Completion: 2018-07
• Study Completion: 2018-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
rate of systolic blood pressure achieving target	at 12 months after PCI	rate of systolic blood pressure achieving target based on guideline
readmission rate	12 months after PCI	readmission rate after PCI
rate of LDL-C achieving target	at 12 months after PCI	rate of LDL-C achieving target based on guideline