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

9 december 2018 bijgewerkt door: 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

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

3111

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 80 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: 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.
Gedragsmatig: meerdere interventies op het gebied van gezondheidseducatie
Placebo-vergelijker: conventional health education
The second group will receive conventional health education during hospitalization except health education manuals, text message and Digital Video Disc (DVD)
Gedragsmatig: meerdere interventies op het gebied van gezondheidseducatie

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
clinical prognosis
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Yongjun Wang

Medewerkers

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

Onderzoekers

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

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 mei 2014

Primaire voltooiing (Werkelijk)

28 juni 2015

Studie voltooiing (Werkelijk)

30 september 2015

Studieregistratiedata

Eerst ingediend

5 mei 2014

Eerst ingediend dat voldeed aan de QC-criteria

14 mei 2014

Eerst geplaatst (Schatting)

16 mei 2014

Updates van studierecords

Laatste update geplaatst (Werkelijk)

11 december 2018

Laatste update ingediend die voldeed aan QC-criteria

9 december 2018

Laatst geverifieerd

1 december 2018

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • TTYY-20131201

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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