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

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02847078
Acronym
SPASCPM
Enrollment
86
Registered
2016-07-28
Start date
2016-09-20
Completion date
2017-05-01
Last updated
2022-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Disease

Keywords

Coronary Disease, percutaneous coronary intervention, secondary prevention, smart phone app

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.

Interventions

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.

DEVICEA guideline booklet

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

Sponsors

First Affiliated Hospital Xi'an Jiaotong University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
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).

Design outcomes

Primary

MeasureTime frameDescription
Change in quality of lifeBaseline and 1 and 6 monthsSeatt1e Angina Questionnaire

Secondary

MeasureTime frameDescription
Change in medication complianceBaseline and 1 and 6 monthsPercent of prescribed antiplatelet drug,ᵦ-blocker,angiotensin converting enzyme inhibitor,angiotensin II receptor blocker and statins taken during the past 1 and 6 monthers
Change in systolic bloodBaseline and 1 and 6 monthssystolic blood pressure is measured via pressuremercury sphygmomanometer and recored in the unit of mmHg.
Change in diastolic blood pressureBaseline and 1 and 6 monthsDiastolic blood pressure is measured via pressuremercury sphygmomanometer and recored in the unit of mmHg.
Changes in serum low-density lipoproteincholesterolBaseline and 1 and 6 monthsSerum low-density lipoproteincholesterol is measured by automatic biochemistry analyzer and recorded in the unit of mmol/L.
Changes in serum triglycerideBaseline and 1 and 6 monthsSerum triglyceride is measured by automatic biochemistry analyzer and recorded in the unit of mmol/L.
Changes in serum high-density lipoproteincholesterolBaseline and 1 and 6 monthsSerum high-density lipoproteincholesterol is measured by automatic biochemistry analyzer and recorded in the unit of mmol/L.
Changes in serum total cholesterolBaseline and 1 and 6 monthsSerum total cholesterol is measured by automatic biochemistry analyzer and recorded in the unit of mmol/L.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026