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

19. maj 2022 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

86

Fase

  • Ikke anvendelig

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Enhed: 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.
Andet: Control group
Participants allocated to the control group will receive a booklet with general advice on secondary prevention of coronary artery disease.
Enhed: A guideline booklet
A guideline booklet with general advice on secondary prevention of coronary artery disease.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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
Baseline and 1 and 6 months
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.
Baseline and 1 and 6 months
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
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.
Baseline and 1 and 6 months
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.
Baseline and 1 and 6 months
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.
Baseline and 1 and 6 months
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.
Baseline and 1 and 6 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

First Affiliated Hospital Xi'an Jiaotong University

Efterforskere

  • Ledende efterforsker: Jingwen Hu, Master, First Affiliated Hospital Xi'an Jiaotong University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

20. september 2016

Primær færdiggørelse (Faktiske)

1. april 2017

Studieafslutning (Faktiske)

1. maj 2017

Datoer for studieregistrering

Først indsendt

13. juli 2016

Først indsendt, der opfyldte QC-kriterier

27. juli 2016

Først opslået (Skøn)

28. juli 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

25. maj 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. maj 2022

Sidst verificeret

1. april 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • XAJTUFH2016
  • 2016JM8116 (Andet bevillings-/finansieringsnummer: Science and Technology Department of Shaanxi Province, China)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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Betingelser

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Kosttilskud

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Placeringer

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