Smart Phone Application in the Secondary Clinical Prevention Management for Chinese Patients (SPASCPM)
19. mai 2022 oppdatert av: First Affiliated Hospital Xi'an Jiaotong University
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.
Studieoversikt
Status
Avsluttet
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Faktiske)
86
Fase
- Ikke aktuelt
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 65 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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).
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Smart phone app
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.
|
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.
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Annen: Control group
Participants allocated to the control group will receive a booklet with general advice on secondary prevention of coronary artery disease.
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A guideline booklet with general advice on secondary prevention of coronary artery disease.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in quality of life
Tidsramme: Baseline and 1 and 6 months
|
Seatt1e Angina Questionnaire
|
Baseline and 1 and 6 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in medication compliance
Tidsramme: Baseline and 1 and 6 months
|
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
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Baseline and 1 and 6 months
|
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Change in systolic blood
Tidsramme: Baseline and 1 and 6 months
|
systolic blood pressure is measured via pressuremercury sphygmomanometer and recored in the unit of mmHg.
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Baseline and 1 and 6 months
|
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Change in diastolic blood pressure
Tidsramme: Baseline and 1 and 6 months
|
Diastolic blood pressure is measured via pressuremercury sphygmomanometer and recored in the unit of mmHg.
|
Baseline and 1 and 6 months
|
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Changes in serum total cholesterol
Tidsramme: Baseline and 1 and 6 months
|
Serum total cholesterol is measured by automatic biochemistry analyzer and recorded in the unit of mmol/L.
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Baseline and 1 and 6 months
|
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Changes in serum triglyceride
Tidsramme: Baseline and 1 and 6 months
|
Serum triglyceride is measured by automatic biochemistry analyzer and recorded in the unit of mmol/L.
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Baseline and 1 and 6 months
|
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Changes in serum high-density lipoproteincholesterol
Tidsramme: Baseline and 1 and 6 months
|
Serum high-density lipoproteincholesterol is measured by automatic biochemistry analyzer and recorded in the unit of mmol/L.
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Baseline and 1 and 6 months
|
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Changes in serum low-density lipoproteincholesterol
Tidsramme: Baseline and 1 and 6 months
|
Serum low-density lipoproteincholesterol is measured by automatic biochemistry analyzer and recorded in the unit of mmol/L.
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Baseline and 1 and 6 months
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Jingwen Hu, Master, First Affiliated Hospital Xi'an Jiaotong University
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
- 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.
- Bommer WJ. Coronary revascularization: then, now, future trends. Rev Cardiovasc Med. 2014;15(2):176-7. doi: 10.3909/ricm15-2CAACC. No abstract available.
- 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.
- 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.
- 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.
- 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.
- 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].
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
20. september 2016
Primær fullføring (Faktiske)
1. april 2017
Studiet fullført (Faktiske)
1. mai 2017
Datoer for studieregistrering
Først innsendt
13. juli 2016
Først innsendt som oppfylte QC-kriteriene
27. juli 2016
Først lagt ut (Anslag)
28. juli 2016
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
25. mai 2022
Siste oppdatering sendt inn som oppfylte QC-kriteriene
19. mai 2022
Sist bekreftet
1. april 2016
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- XAJTUFH2016
- 2016JM8116 (Annet stipend/finansieringsnummer: Science and Technology Department of Shaanxi Province, China)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
UBESLUTTE
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