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

Primary Purpose

Coronary Disease

Status
Terminated
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
smart phone app
A guideline booklet
Sponsored by
First Affiliated Hospital Xi'an Jiaotong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Coronary Disease focused on measuring Coronary Disease, percutaneous coronary intervention, secondary prevention, smart phone app

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    Smart phone app

    Control group

    Arm 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.

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

    Outcomes

    Primary Outcome Measures

    Change in quality of life
    Seatt1e Angina Questionnaire

    Secondary Outcome Measures

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

    Full Information

    First Posted
    July 13, 2016
    Last Updated
    May 19, 2022
    Sponsor
    First Affiliated Hospital Xi'an Jiaotong University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02847078
    Brief Title
    Smart Phone Application in the Secondary Clinical Prevention Management for Chinese Patients
    Acronym
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2016
    Overall Recruitment Status
    Terminated
    Why Stopped
    Insufficient enrollment of patients
    Study Start Date
    September 20, 2016 (Actual)
    Primary Completion Date
    April 1, 2017 (Actual)
    Study Completion Date
    May 1, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    First Affiliated Hospital Xi'an Jiaotong University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Coronary Disease
    Keywords
    Coronary Disease, percutaneous coronary intervention, secondary prevention, smart phone app

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    86 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Smart phone app
    Arm Type
    Experimental
    Arm 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.
    Arm Title
    Control group
    Arm Type
    Other
    Arm Description
    Participants allocated to the control group will receive a booklet with general advice on secondary prevention of coronary artery disease.
    Intervention Type
    Device
    Intervention Name(s)
    smart phone app
    Intervention Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    A guideline booklet
    Intervention Description
    A guideline booklet with general advice on secondary prevention of coronary artery disease.
    Primary Outcome Measure Information:
    Title
    Change in quality of life
    Description
    Seatt1e Angina Questionnaire
    Time Frame
    Baseline and 1 and 6 months
    Secondary Outcome Measure Information:
    Title
    Change in medication compliance
    Description
    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
    Time Frame
    Baseline and 1 and 6 months
    Title
    Change in systolic blood
    Description
    systolic blood pressure is measured via pressuremercury sphygmomanometer and recored in the unit of mmHg.
    Time Frame
    Baseline and 1 and 6 months
    Title
    Change in diastolic blood pressure
    Description
    Diastolic blood pressure is measured via pressuremercury sphygmomanometer and recored in the unit of mmHg.
    Time Frame
    Baseline and 1 and 6 months
    Title
    Changes in serum total cholesterol
    Description
    Serum total cholesterol is measured by automatic biochemistry analyzer and recorded in the unit of mmol/L.
    Time Frame
    Baseline and 1 and 6 months
    Title
    Changes in serum triglyceride
    Description
    Serum triglyceride is measured by automatic biochemistry analyzer and recorded in the unit of mmol/L.
    Time Frame
    Baseline and 1 and 6 months
    Title
    Changes in serum high-density lipoproteincholesterol
    Description
    Serum high-density lipoproteincholesterol is measured by automatic biochemistry analyzer and recorded in the unit of mmol/L.
    Time Frame
    Baseline and 1 and 6 months
    Title
    Changes in serum low-density lipoproteincholesterol
    Description
    Serum low-density lipoproteincholesterol is measured by automatic biochemistry analyzer and recorded in the unit of mmol/L.
    Time Frame
    Baseline and 1 and 6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    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).
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jingwen Hu, Master
    Organizational Affiliation
    First Affiliated Hospital Xi'an Jiaotong University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    25051135
    Citation
    Bommer WJ. Coronary revascularization: then, now, future trends. Rev Cardiovasc Med. 2014;15(2):176-7. doi: 10.3909/ricm15-2CAACC. No abstract available.
    Results Reference
    result
    PubMed Identifier
    23281080
    Citation
    White CJ. The future of interventional cardiology. Catheter Cardiovasc Interv. 2013 Jan 1;81(1):4-5. doi: 10.1002/ccd.24734. No abstract available.
    Results Reference
    result
    PubMed Identifier
    19949634
    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.
    Results Reference
    result
    PubMed Identifier
    25301783
    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 management patterns In acute CORonary syndrome patients) study. Eur Heart J Acute Cardiovasc Care. 2015 Dec;4(6):509-17. doi: 10.1177/2048872614554198. Epub 2014 Oct 9.
    Results Reference
    result
    PubMed Identifier
    21576654
    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.110.983536. Epub 2011 May 16.
    Results Reference
    result
    PubMed Identifier
    15364185
    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 study): case-control study. Lancet. 2004 Sep 11-17;364(9438):937-52. doi: 10.1016/S0140-6736(04)17018-9.
    Results Reference
    result
    PubMed Identifier
    24523989
    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.
    Results Reference
    result
    PubMed Identifier
    26530929
    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 young adults using mobile technology. Obesity (Silver Spring). 2015 Nov;23(11):2133-41. doi: 10.1002/oby.21226. Erratum In: Obesity (Silver Spring). 2016 Feb;24(2):536. Bennett, G B [Corrected to Bennett, G G].
    Results Reference
    result

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

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