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

May 19, 2022 updated by: First Affiliated Hospital Xi'an Jiaotong University

Effects of a Smart Phone Application in the Secondary Clinical Prevention Management for Chinese Patients After Coronary Intervention Treatment: a Randomized Controlled Trial

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

86

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in quality of life
Time Frame: Baseline and 1 and 6 months
Seatt1e Angina Questionnaire
Baseline and 1 and 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in medication compliance
Time Frame: 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
Baseline and 1 and 6 months
Change in systolic blood
Time Frame: Baseline and 1 and 6 months
systolic blood pressure is measured via pressuremercury sphygmomanometer and recored in the unit of mmHg.
Baseline and 1 and 6 months
Change in diastolic blood pressure
Time Frame: Baseline and 1 and 6 months
Diastolic blood pressure is measured via pressuremercury sphygmomanometer and recored in the unit of mmHg.
Baseline and 1 and 6 months
Changes in serum total cholesterol
Time Frame: Baseline and 1 and 6 months
Serum total cholesterol is measured by automatic biochemistry analyzer and recorded in the unit of mmol/L.
Baseline and 1 and 6 months
Changes in serum triglyceride
Time Frame: Baseline and 1 and 6 months
Serum triglyceride is measured by automatic biochemistry analyzer and recorded in the unit of mmol/L.
Baseline and 1 and 6 months
Changes in serum high-density lipoproteincholesterol
Time Frame: Baseline and 1 and 6 months
Serum high-density lipoproteincholesterol is measured by automatic biochemistry analyzer and recorded in the unit of mmol/L.
Baseline and 1 and 6 months
Changes in serum low-density lipoproteincholesterol
Time Frame: Baseline and 1 and 6 months
Serum low-density lipoproteincholesterol is measured by automatic biochemistry analyzer and recorded in the unit of mmol/L.
Baseline and 1 and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital Xi'an Jiaotong University

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 20, 2016

Primary Completion (Actual)

April 1, 2017

Study Completion (Actual)

May 1, 2017

Study Registration Dates

First Submitted

July 13, 2016

First Submitted That Met QC Criteria

July 27, 2016

First Posted (Estimate)

July 28, 2016

Study Record Updates

Last Update Posted (Actual)

May 25, 2022

Last Update Submitted That Met QC Criteria

May 19, 2022

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XAJTUFH2016
  • 2016JM8116 (Other Grant/Funding Number: Science and Technology Department of Shaanxi Province, China)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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