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

Coronary Disease Clinical Trial

— SPASCPM  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02847078
• Other study ID #: XAJTUFH2016
• Secondary ID: 2016JM8116
• Status: Terminated
• Phase: N/A
• Start date: September 20, 2016
• Est. completion date: May 1, 2017

Study information

• Verified date: April 2016
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 86
• Est. completion date: May 1, 2017
• Est. primary completion date: April 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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 ?-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).

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University

References & Publications (8)

Bommer WJ. Coronary revascularization: then, now, future trends. Rev Cardiovasc Med. 2014;15(2):176-7. doi: 10.3909/ricm15-2CAACC. — View Citation

Goel K, Lennon RJ, Tilbury RT, Squires RW, Thomas RJ. Impact of cardiac rehabilitation on mortality and cardiovascular events after percutaneous coronary intervention in the community. Circulation. 2011 May 31;123(21):2344-52. doi: 10.1161/CIRCULATIONAHA. — View Citation

Heo J, Chun M, Lee KY, Oh YT, Noh OK, Park RW. Effects of a smartphone application on breast self-examination: a feasibility study. Healthc Inform Res. 2013 Dec;19(4):250-60. doi: 10.4258/hir.2013.19.4.250. Epub 2013 Dec 31. — View Citation

Pocock S, Bueno H, Licour M, Medina J, Zhang L, Annemans L, Danchin N, Huo Y, Van de Werf F. Predictors of one-year mortality at hospital discharge after acute coronary syndromes: A new risk score from the EPICOR (long-tErm follow uP of antithrombotic man — View Citation

Sim DS, Kim JH, Jeong MH. Differences in Clinical Outcomes Between Patients With ST-Elevation Versus Non-ST-Elevation Acute Myocardial Infarction in Korea. Korean Circ J. 2009 Aug;39(8):297-303. doi: 10.4070/kcj.2009.39.8.297. Epub 2009 Aug 27. — View Citation

Svetkey LP, Batch BC, Lin PH, Intille SS, Corsino L, Tyson CC, Bosworth HB, Grambow SC, Voils C, Loria C, Gallis JA, Schwager J, Bennett GG. Cell phone intervention for you (CITY): A randomized, controlled trial of behavioral weight loss intervention for — View Citation

White CJ. The future of interventional cardiology. Catheter Cardiovasc Interv. 2013 Jan 1;81(1):4-5. doi: 10.1002/ccd.24734. — View Citation

Yusuf S, Hawken S, Ounpuu S, Dans T, Avezum A, Lanas F, McQueen M, Budaj A, Pais P, Varigos J, Lisheng L; INTERHEART Study Investigators. Effect of potentially modifiable risk factors associated with myocardial infarction in 52 countries (the INTERHEART s — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in quality of life	Seatt1e Angina Questionnaire	Baseline and 1 and 6 months
Secondary	Change in medication compliance	Percent of prescribed antiplatelet drug,?-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
Secondary	Change in systolic blood	systolic blood pressure is measured via pressuremercury sphygmomanometer and recored in the unit of mmHg.	Baseline and 1 and 6 months
Secondary	Change in diastolic blood pressure	Diastolic blood pressure is measured via pressuremercury sphygmomanometer and recored in the unit of mmHg.	Baseline and 1 and 6 months
Secondary	Changes in serum total cholesterol	Serum total cholesterol is measured by automatic biochemistry analyzer and recorded in the unit of mmol/L.	Baseline and 1 and 6 months
Secondary	Changes in serum triglyceride	Serum triglyceride is measured by automatic biochemistry analyzer and recorded in the unit of mmol/L.	Baseline and 1 and 6 months
Secondary	Changes in serum high-density lipoproteincholesterol	Serum high-density lipoproteincholesterol is measured by automatic biochemistry analyzer and recorded in the unit of mmol/L.	Baseline and 1 and 6 months
Secondary	Changes in serum low-density lipoproteincholesterol	Serum low-density lipoproteincholesterol is measured by automatic biochemistry analyzer and recorded in the unit of mmol/L.	Baseline and 1 and 6 months