CClinicalTrials.gg
Status unknownNCT03059784Updated Feb 23, 2017

APP-based Multifaceted Management After PCI

An interventional study of APP-based multifaceted management in Percutaneous Coronary Intervention, sponsored by Chinese Academy of Medical Sciences, Fuwai Hospital. Status unknown. Per ClinicalTrials.gov, last updated 2017-02-23.

Sponsored by Chinese Academy of Medical Sciences, Fuwai Hospital · Not applicable, Interventional, and Other

The sponsor has not verified this record recently (last verified Feb 2017), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
1,100
Allocation
Randomized
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Percutaneous Coronary Intervention
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In context

Lead sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital is the lead sponsor of 141 studies on the registry; 48 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • patients who are not able to use APP;
  • dementia;
  • mental disturbed;
  • patients who are not willing to receive management and follow up.
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Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
1,100 participants (estimated)

Study arms

  • 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

  • No intervention
    control

    usual care without APP

Interventions

  • OtherAPP-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.

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What researchers measure

Primary outcomes

  1. 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

    Time frame: at 12 months after PCI

Secondary outcomes

  1. rate of LDL-C achieving target

    rate of LDL-C achieving target based on guideline

    Time frame: at 12 months after PCI

  2. rate of systolic blood pressure achieving target

    rate of systolic blood pressure achieving target based on guideline

    Time frame: at 12 months after PCI

  3. readmission rate

    readmission rate after PCI

    Time frame: 12 months after PCI

Other outcomes

  1. smoking status (the proportion of participants with smoking cessation)

    the proportion of participants with smoking cessation

    Time frame: at 12 months after PCI

  2. rehabilitation (the proportion of participants who receive rehabilitation program)

    the proportion of participants who receive rehabilitation program

    Time frame: 12 months after PCI

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Study locations

No study locations are listed for this record.

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References and documents

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

Individual participant data

Plan to share: Yes — management methods,outcomes including medication use, events of patients can be available on request.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 23, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03059784
Lead sponsor
Chinese Academy of Medical Sciences, Fuwai Hospital
Responsible party
Yongjian Wu (Associate director of Coronary Artery Disease Center, Chinese Academy of Medical Sciences, Fuwai Hospital) — Principal investigator
First posted
Feb 23, 2017
Start date
Mar 2017 (estimated)
Primary completion
Jul 2018 (estimated)
Completion
Aug 2018 (estimated)
Last update
Feb 23, 2017

Study contacts

HAIYAN XU
Contact
hyxu@yahoo.com
Yongjian Wu
study chair · Chinese Academy of Medical Sciences, Fuwai Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.

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