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

9 dicembre 2018 aggiornato da: 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

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

3111

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 80 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: 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.
Comportamentale: molteplici interventi di educazione sanitaria
Comparatore placebo: conventional health education
The second group will receive conventional health education during hospitalization except health education manuals, text message and Digital Video Disc (DVD)
Comportamentale: molteplici interventi di educazione sanitaria

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
clinical prognosis
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Yongjun Wang

Collaboratori

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

Investigatori

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

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 maggio 2014

Completamento primario (Effettivo)

28 giugno 2015

Completamento dello studio (Effettivo)

30 settembre 2015

Date di iscrizione allo studio

Primo inviato

5 maggio 2014

Primo inviato che soddisfa i criteri di controllo qualità

14 maggio 2014

Primo Inserito (Stima)

16 maggio 2014

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

11 dicembre 2018

Ultimo aggiornamento inviato che soddisfa i criteri QC

9 dicembre 2018

Ultimo verificato

1 dicembre 2018

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • TTYY-20131201

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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