Clinical trial NCT03059784: APP-based Multifaceted Management After PCI
Official title: Mobile Application-based Multifaceted Management to Improve Long-term Care After Percutaneous Coronary Intervention
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Percutaneous Coronary Intervention
Lead sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
Sponsor class: OTHER
First posted: 2017-02-23
Enrollment: 1100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: evidence-based medication adherence (the proportion of participants taking 3 medications (aspirin, P2Y12 receptor inhibitor, statin) without contraindications)
timeFrame: at 12 months after PCI
Secondary outcomes:
measure: rate of LDL-C achieving target
timeFrame: at 12 months after PCI
measure: rate of systolic blood pressure achieving target
timeFrame: at 12 months after PCI
measure: readmission rate
timeFrame: 12 months after PCI
Other outcomes:
measure: smoking status (the proportion of participants with smoking cessation)
timeFrame: at 12 months after PCI
measure: rehabilitation (the proportion of participants who receive rehabilitation program)
timeFrame: 12 months after PCI
Locations:
Study officials:
affiliation: Chinese Academy of Medical Sciences, Fuwai Hospital
name: Yongjian Wu
role: STUDY_CHAIR
References:
citation: 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