Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

APP-based Multifaceted Management After PCI

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03059784
Recruitment Status : Unknown
Verified February 2017 by Yongjian Wu, Chinese Academy of Medical Sciences, Fuwai Hospital.
Recruitment status was:  Not yet recruiting
First Posted : February 23, 2017
Last Update Posted : February 23, 2017
Sponsor:
Information provided by (Responsible Party):
Yongjian Wu, 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.

Condition or disease Intervention/treatment Phase
Percutaneous Coronary Intervention Other: APP-based multifaceted management Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Official Title: Mobile Application-based Multifaceted Management to Improve Long-term Care After Percutaneous Coronary Intervention
Estimated Study Start Date : March 2017
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : August 2018

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



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. rate of LDL-C achieving target [ Time Frame: at 12 months after PCI ]
    rate of LDL-C achieving target based on guideline

  2. rate of systolic blood pressure achieving target [ Time Frame: at 12 months after PCI ]
    rate of systolic blood pressure achieving target based on guideline

  3. readmission rate [ Time Frame: 12 months after PCI ]
    readmission rate after PCI


Other Outcome Measures:
  1. smoking status (the proportion of participants with smoking cessation) [ Time Frame: at 12 months after PCI ]
    the proportion of participants with smoking cessation

  2. rehabilitation (the proportion of participants who receive rehabilitation program) [ Time Frame: 12 months after PCI ]
    the proportion of participants who receive rehabilitation program



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03059784


Contacts
Layout table for location contacts
Contact: HAIYAN XU hyxu@yahoo.com

Sponsors and Collaborators
Chinese Academy of Medical Sciences, Fuwai Hospital
Investigators
Layout table for investigator information
Study Chair: Yongjian Wu Fuwai Hospital

Publications:
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

Layout table for additonal information
Responsible Party: Yongjian Wu, Associate director of Coronary Artery Disease Center, Chinese Academy of Medical Sciences, Fuwai Hospital
ClinicalTrials.gov Identifier: NCT03059784    
Other Study ID Numbers: 2016-ZX16
First Posted: February 23, 2017    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: management methods,outcomes including medication use, events of patients can be available on request.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No