SPASCPM: Smart Phone Application in the Secondary Clinical Prevention Management for Chinese Patients

Sponsor
First Affiliated Hospital Xi'an Jiaotong University (Other)
Overall Status
Terminated
CT.gov ID
NCT02847078
Collaborator
(none)
86
2
7.3

Study Details

Study Description

Brief Summary

The purpose of the study is to investigate the effects of smart phone app on the secondary prevention for patients with coronary heart disease post percutaneous coronary intervention.

Condition or Disease Intervention/Treatment Phase
  • Device: smart phone app
  • Device: A guideline booklet
N/A

Detailed Description

The secondary prevention for patients with coronary heart disease post percutaneous coronary intervention (PCI) proved associated with a significant reduction in mortality rates and improvement in quality of life. For the limitation of socio-economic conditions, not all patients post PCI are in a position to receive continuous standardized secondary prevention management. Therefore a smart phone app for secondary prevention management post PCI will be installed on patients' smart phones in order to investigate its effects on risk factors control, medication compliance, as well as quality of life and adverse cardiac events in the next six months post discharge. Participants allocated to the control group will receive a booklet with general advice on secondary prevention of coronary heart disease. Patients in app group and control group will be interviewed by telephone at the 2nd week and the 3rd month, and at the 1st month and 6th month they will return our hospital for face to face follow-up and to compliance and medication adjustment, assessment of life quality, risk factors control and medication adherence.

Study Design

Study Type:
Interventional
Actual Enrollment :
86 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Prevention
Official Title:
Effects of a Smart Phone Application in the Secondary Clinical Prevention Management for Chinese Patients After Coronary Intervention Treatment: a Randomized Controlled Trial
Actual Study Start Date :
Sep 20, 2016
Actual Primary Completion Date :
Apr 1, 2017
Actual Study Completion Date :
May 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: Smart phone app

The app contains education materials for secondary prevention of coronary artery disease. So patients can access them very easily. The app pushes heath management recommendation information on the timeline after percutaneous coronary intervention, and also provides health care lecture to help patients to improve their secondary prevention. And online or telephone consultation ways are integrated into the App to provide convenience for patients to communicate with health care professionals.

Device: smart phone app
App for this study is provided with real time updating educational materials, reminder, and consultation for improving secondary prevention, and the related information is pushed to a patient in chronological order after his or her PCI operation.

Other: Control group

Participants allocated to the control group will receive a booklet with general advice on secondary prevention of coronary artery disease.

Device: A guideline booklet
A guideline booklet with general advice on secondary prevention of coronary artery disease.

Outcome Measures

Primary Outcome Measures

  1. Change in quality of life [Baseline and 1 and 6 months]

    Seatt1e Angina Questionnaire

Secondary Outcome Measures

  1. Change in medication compliance [Baseline and 1 and 6 months]

    Percent of prescribed antiplatelet drug,ᵦ-blocker,angiotensin converting enzyme inhibitor,angiotensin II receptor blocker and statins taken during the past 1 and 6 monthers

  2. Change in systolic blood [Baseline and 1 and 6 months]

    systolic blood pressure is measured via pressuremercury sphygmomanometer and recored in the unit of mmHg.

  3. Change in diastolic blood pressure [Baseline and 1 and 6 months]

    Diastolic blood pressure is measured via pressuremercury sphygmomanometer and recored in the unit of mmHg.

  4. Changes in serum total cholesterol [Baseline and 1 and 6 months]

    Serum total cholesterol is measured by automatic biochemistry analyzer and recorded in the unit of mmol/L.

  5. Changes in serum triglyceride [Baseline and 1 and 6 months]

    Serum triglyceride is measured by automatic biochemistry analyzer and recorded in the unit of mmol/L.

  6. Changes in serum high-density lipoproteincholesterol [Baseline and 1 and 6 months]

    Serum high-density lipoproteincholesterol is measured by automatic biochemistry analyzer and recorded in the unit of mmol/L.

  7. Changes in serum low-density lipoproteincholesterol [Baseline and 1 and 6 months]

    Serum low-density lipoproteincholesterol is measured by automatic biochemistry analyzer and recorded in the unit of mmol/L.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • First diagnosis of coronary heart disease and received a PCI treatment.

  • Age 18-65 years.

  • Able and willing to provide written informed consent.

Exclusion Criteria:
  • Speech communication barriers.

  • Patients with a clear history of allergies to anti-platelet drugs.

  • Patients with a clear history of allergies to anti-platelet ᵦ-blockers.

  • Patients with a clear history of allergies to statin drugs.

  • Patients with a clear history of allergies to antihypertensive drugs.

  • Patients with a clear history of allergies to antidiabetic drugs.

  • Patients with serious heart failure(better than NYHA class II).

  • Patients with cerebral infarction or cerebral hemorrhage.

  • Patients with liver dysfunction (AST and ALT> 2 times that of the reference value).

  • Patients with kidney dysfunction (creatinine clearance rate< 60ml/min).

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • First Affiliated Hospital Xi'an Jiaotong University

Investigators

  • Principal Investigator: Jingwen Hu, Master, First Affiliated Hospital Xi'an Jiaotong University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
First Affiliated Hospital Xi'an Jiaotong University
ClinicalTrials.gov Identifier:
NCT02847078
Other Study ID Numbers:
  • XAJTUFH2016
  • 2016JM8116
First Posted:
Jul 28, 2016
Last Update Posted:
May 25, 2022
Last Verified:
Apr 1, 2016
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Keywords provided by First Affiliated Hospital Xi'an Jiaotong University
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 25, 2022