APP-based Multifaceted Management After PCI

Study Overview
=================
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.

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

Conditions
-----------------
Percutaneous Coronary Intervention

Intervention / Treatment
-----------------
* Other: APP-based multifaceted management


Participation Criteria
=================
Eligibility Criteria
-----------------
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.
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intervention<br>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<br>* 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.<br>|
| No Intervention: control<br>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) | 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 | rate of LDL-C achieving target based on guideline | at 12 months after PCI | 
| rate of systolic blood pressure achieving target | rate of systolic blood pressure achieving target based on guideline | at 12 months after PCI | 
| readmission rate | readmission rate after PCI | 12 months after PCI |