Clinical trial NCT02847078: Smart Phone Application in the Secondary Clinical Prevention Management for Chinese Patients
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Coronary Disease
Keywords: Coronary Disease
percutaneous coronary intervention
secondary prevention
smart phone app
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2016-07-28
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Change in quality of life
timeFrame: Baseline and 1 and 6 months
Secondary outcomes:
measure: Change in medication compliance
timeFrame: Baseline and 1 and 6 months
measure: Change in systolic blood
timeFrame: Baseline and 1 and 6 months
measure: Change in diastolic blood pressure
timeFrame: Baseline and 1 and 6 months
measure: Changes in serum total cholesterol
timeFrame: Baseline and 1 and 6 months
measure: Changes in serum triglyceride
timeFrame: Baseline and 1 and 6 months
measure: Changes in serum high-density lipoproteincholesterol
timeFrame: Baseline and 1 and 6 months
measure: Changes in serum low-density lipoproteincholesterol
timeFrame: Baseline and 1 and 6 months
Other outcomes:
Locations:
Study officials:
affiliation: First Affiliated Hospital Xi'an Jiaotong University
name: Jingwen Hu, Master
role: PRINCIPAL_INVESTIGATOR
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