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Coronary DiseaseSPASCPMNCT02847078

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

A study testing smart phone app and A guideline booklet in people with Coronary Disease, run by First Affiliated Hospital Xi'an Jiaotong University.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Coronary Disease
What is being tested?
smart phone app and A guideline booklet
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
86 participants
Where
No sites listed yet
Study dates
20 Sep 2016to 1 May 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • First diagnosis of coronary heart disease and received a PCI treatment.
  • Age 18-65 years.
  • Able and willing to provide written informed consent.

Who cannot join

  • 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.
Show all 10Show fewer
  • 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).

About this study

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

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.

Read the 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.

Being tested
smart phone app, A guideline booklet
Keywords
Coronary Disease, percutaneous coronary intervention, secondary prevention, smart phone app
Medical subject headings
Coronary Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • smart phone appDevice

    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 bookletDevice

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

Study groups in NCT02847078
Study groupRoleWhat they receive
Smart phone appExperimentalThe 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.
Receives: Device: smart phone app
Control groupOtherParticipants allocated to the control group will receive a booklet with general advice on secondary prevention of coronary artery disease.
Receives: Device: A guideline booklet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in quality of life

    Seatt1e Angina Questionnaire

    Measured: Baseline and 1 and 6 months

Secondary outcomes (7)

  1. 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

    Measured: Baseline and 1 and 6 months

  2. Change in systolic blood

    systolic blood pressure is measured via pressuremercury sphygmomanometer and recored in the unit of mmHg.

    Measured: Baseline and 1 and 6 months

  3. Change in diastolic blood pressure

    Diastolic blood pressure is measured via pressuremercury sphygmomanometer and recored in the unit of mmHg.

    Measured: Baseline and 1 and 6 months

  4. Changes in serum total cholesterol

    Serum total cholesterol is measured by automatic biochemistry analyzer and recorded in the unit of mmol/L.

    Measured: Baseline and 1 and 6 months

  5. Changes in serum triglyceride

    Serum triglyceride is measured by automatic biochemistry analyzer and recorded in the unit of mmol/L.

    Measured: Baseline and 1 and 6 months

  6. Changes in serum high-density lipoproteincholesterol

    Serum high-density lipoproteincholesterol is measured by automatic biochemistry analyzer and recorded in the unit of mmol/L.

    Measured: Baseline and 1 and 6 months

  7. Changes in serum low-density lipoproteincholesterol

    Serum low-density lipoproteincholesterol is measured by automatic biochemistry analyzer and recorded in the unit of mmol/L.

    Measured: Baseline and 1 and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jul 2016 (estimated)
  2. Study start20 Sep 2016
  3. Primary completion1 Apr 2017
  4. Study completion1 May 2017

Why it stopped: Insufficient enrollment of patients

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
86 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02847078
Sponsor's protocol ID
XAJTUFH2016
Other IDs
2016JM8116
Acronym
SPASCPM
Status last verified
Apr 2016
First submitted
13 Jul 2016
Last updated
25 May 2022
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • Bommer WJ. Coronary revascularization: then, now, future trends. Rev Cardiovasc Med. 2014;15(2):176-7. doi: 10.3909/ricm15-2CAACC. No abstract available.

    PubMed 25051135

  • 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.

    PubMed 23281080

  • 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.

    PubMed 19949634

  • 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.

    PubMed 25301783

  • 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.

    PubMed 21576654

  • 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.

    PubMed 15364185

  • 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.

    PubMed 24523989

  • 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.

    PubMed 26530929

Questions about this trial

What is this clinical trial studying?

A study testing smart phone app and A guideline booklet in people with Coronary Disease, run by First Affiliated Hospital Xi'an Jiaotong University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 25 May 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Insufficient enrollment of patients). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in quality of life (time frame: Baseline and 1 and 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02847078, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2022.

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