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

Xi'an Jiaotong University

Status: Terminated

Conditions: Coronary Disease

Treatments: Device: A guideline booklet; Device: smart phone app

Study type: Interventional

Funder types: Other

Identifiers

NCT02847078

XAJTUFH2016

2016JM8116 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 86 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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86 participants in 2 patient groups

Smart phone app

Experimental group

Description:

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.

Treatment:

Device: smart phone app

Control group

Other group

Description:

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

Treatment:

Device: A guideline booklet