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Affect of Multiple Health Education on Medication Persistence and Clinical Prognosis of Ischemic Stroke Patients

9. december 2018 opdateret af: yongjun wang, Yongjun Wang

Affect of Multiple Health Education Interventions on Secondary Prevention Medication Persistence and Clinical Prognosis of Ischemic Stroke Patients: a Prospective Cohort Study

The study aimed to demonstrate the relationship between secondary prevention medication persistence and clinical prognosis of ischemic stroke patients at 3,6,12 months

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The study is a prospective, multicenter, hospital-based study on secondary prevention for patients with ischemic cerebrovascular diseases between May 2014 and June 2015. Physicians from 24 hospitals in Beijing underwent a standard secondary prevention training of ischemic cerebrovascular diseases by professional training, instruction manuals, stratification management software. In order to improve the persistence of taking preventive secondary medicine, IS patients from these 24 hospitals received healthy education through manuals and Digital Video Disc about health education during hospitalization and acquired secondary preventive knowledge of ischemic cerebrovascular diseases through regular health education messages during 6 months after discharge. Patients with IS from other 6 hospitals were used as a control, and no such intervention was given to them.

Telephone follow-up was performed at 3 months, 6 months, and 1 year after the onset of cerebral infarction, during which the use of antiplatelet and statins drugs and recurrence of IS were recorded. Patients who took antiplatelet drugs or statins at three follow-ups were regarded as persistent antiplatelet drugs or statins taking within one year after the onset of the disease. The main prognostic indicator was the recurrence of IS and persistence of antiplatelet and statins medication within 1 year, and the main purpose was to explore the impact of persistent statins and antiplatelet medication use on IS recurrence.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

3111

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Kina
    • Beijing
      • Beijing, Beijing, Kina, 100050
        • Beijing Tian Tan Hospital, Capital Medical University

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 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Adult subjects (male or female ≥18 years);
  2. Acute ischemic stroke occured within 14 days of symptoms onset
  3. Patients signed informed consent
  4. Patients have a cell phone and have the ability to receive and view messages

Exclusion Criteria:

  1. Non-cerebrovascular events or hemorrhagic stroke
  2. Patients have serious heart, liver, kidney dysfunction or coagulation disorders
  3. Patients have circumstances that may affect the follow-up such as disturbance of consciousness, severe depression or other mental disorders, aphasia
  4. Modified Rankin Scale score at discharge ≥3
  5. Those who are participating in other clinical trials
  6. Those who can not guarantee with the completion of 1 year follow-up after enrollment

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: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: multiple health education interventions
The group will receive health education manuals and Digital Video Disc (DVD) during hospitalization and regular text message during 1 year after discharge.
Adfærdsmæssigt: flere sundhedspædagogiske interventioner
Placebo komparator: conventional health education
The second group will receive conventional health education during hospitalization except health education manuals, text message and Digital Video Disc (DVD)
Adfærdsmæssigt: flere sundhedspædagogiske interventioner

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Proportion of patients who continued taking antiplatelet drugs at three months after stroke onset, and proportion of patients who continued taking statins drugs at three months after stroke onset.
Tidsramme: 3 months after stroke onset
Medication persistence at 3 months. Persistence is defined as continuing a therapy or class of therapy from discharge to the 3 months follow-up. Subjects prescribed an individual medication at discharge but who were not taking that medication at follow up were defined as "nonpersistent". Persistence for the specified medication classes (antiplatelet, statins) was defined in the same way; however, subjects were considered persistent if there was a switch to another medication within the same class.
3 months after stroke onset
Proportion of patients who continued taking antiplatelet drugs at six months after stroke onset, and proportion of patients who continued taking statins drugs at six months after stroke onset.
Tidsramme: 6 months after stroke onset
Medication persistence at 6 months. Persistence at 6 months is defined as continuing a therapy or class of therapy at 6 months follow-up. Subjects prescribed an individual medication at discharge but who were not taking that medication at follow up were defined as "nonpersistent". Persistence for the specified medication classes (antiplatelet, statins) was defined in the same way; however, subjects were considered persistent if there was a switch to another medication within the same class.
6 months after stroke onset
Proportion of patients who continued taking antiplatelet drugs at 12 months after stroke onset, and proportion of patients who continued taking statins drugs at 12 months after stroke onset.
Tidsramme: 12 months after stroke onset
Medication persistence at 12 months. Persistence at 12 months is defined as continuing a therapy or class of therapy at 12 months follow-up. Subjects prescribed an individual medication at discharge but who were not taking that medication at follow up were defined as "nonpersistent". Persistence for the specified medication classes (antiplatelet, statins) was defined in the same way; however, subjects were considered persistent if there was a switch to another medication within the same class.
12 months after stroke onset
Proportion of patients who continued taking antiplatelet drugs in 1 year after stroke onset, and proportion of patients who continued taking statins drugs in 1 year after stroke onset.
Tidsramme: 1 year after stroke onset
Patients who took statins and antiplatelet medications at 3, 6 and 12 months follow-up were regarded as persistent during one year after stroke onset.
1 year after stroke onset
Recurrence of ischemic stroke in three months after stroke onset
Tidsramme: 3 months after stroke onset
Recurrence of IS was defined as a new focal neurological deficit of vascular origin lasting >24 hours and without hemorrhage on computed tomography or MRI of the brain.
3 months after stroke onset
Recurrence of ischemic stroke in six months after stroke onset
Tidsramme: 6 months after stroke onset
Recurrence of IS was defined as a new focal neurological deficit of vascular origin lasting >24 hours and without hemorrhage on computed tomography or MRI of the brain.
6 months after stroke onset
Recurrence of ischemic stroke in 12 months after stroke onset
Tidsramme: 12 months after stroke onset
Recurrence of IS was defined as a new focal neurological deficit of vascular origin lasting >24 hours and without hemorrhage on computed tomography or MRI of the brain.
12 months after stroke onset

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
clinical prognosis
Tidsramme: 3,6,12 months
Death(including Vascular death and non-vascular death); Nonfatal myocardial infarction; Nonfatal hemorrhagic stroke; Severe disabilities(modified Rankin Scale≥4)
3,6,12 months

Samarbejdspartnere og efterforskere

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

Sponsor

Yongjun Wang

Samarbejdspartnere

Ministry of Science and Technology of the People´s Republic of China

Efterforskere

  • Ledende efterforsker: yongjun wang, MD, Beijing Tian Tan Hospital, Capital Medical University, Beijing, China

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)

1. maj 2014

Primær færdiggørelse (Faktiske)

28. juni 2015

Studieafslutning (Faktiske)

30. september 2015

Datoer for studieregistrering

Først indsendt

5. maj 2014

Først indsendt, der opfyldte QC-kriterier

14. maj 2014

Først opslået (Skøn)

16. maj 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

11. december 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. december 2018

Sidst verificeret

1. december 2018

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • TTYY-20131201

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