APP-based Multifaceted Management After PCI

Percutaneous Coronary Intervention Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03059784
• Other study ID #: 2016-ZX16
• Status: Not yet recruiting
• Phase: N/A
• First received: February 17, 2017
• Last updated: February 20, 2017
• Start date: March 2017
• Est. completion date: August 2018

Study information

• Verified date: February 2017
• Source: Chinese Academy of Medical Sciences, Fuwai Hospital
• Contact: HAIYAN XU
• Email: hyxu[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1100
• Est. completion date: August 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Percutaneous Coronary Intervention

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences, Fuwai Hospital

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	smoking status (the proportion of participants with smoking cessation)	the proportion of participants with smoking cessation	at 12 months after PCI
Other	rehabilitation (the proportion of participants who receive rehabilitation program)	the proportion of participants who receive rehabilitation program	12 months after PCI
Primary	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	rate of LDL-C achieving target	rate of LDL-C achieving target based on guideline	at 12 months after PCI
Secondary	rate of systolic blood pressure achieving target	rate of systolic blood pressure achieving target based on guideline	at 12 months after PCI
Secondary	readmission rate	readmission rate after PCI	12 months after PCI