Affect of Multiple Health Education on Medication Persistence and Clinical Prognosis of Ischemic Stroke Patients
9. desember 2018 oppdatert av: 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
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Detaljert 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.
Studietype
Intervensjonell
Registrering (Faktiske)
3111
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Beijing
-
Beijing, Beijing, Kina, 100050
- Beijing Tian Tan Hospital, Capital Medical University
-
-
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 80 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Adult subjects (male or female ≥18 years);
- Acute ischemic stroke occured within 14 days of symptoms onset
- Patients signed informed consent
- Patients have a cell phone and have the ability to receive and view messages
Exclusion Criteria:
- Non-cerebrovascular events or hemorrhagic stroke
- Patients have serious heart, liver, kidney dysfunction or coagulation disorders
- Patients have circumstances that may affect the follow-up such as disturbance of consciousness, severe depression or other mental disorders, aphasia
- Modified Rankin Scale score at discharge ≥3
- Those who are participating in other clinical trials
- Those who can not guarantee with the completion of 1 year follow-up after enrollment
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: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / 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.
|
|
|
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)
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: yongjun wang, MD, Beijing Tian Tan Hospital, Capital Medical University, Beijing, China
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.
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)
1. mai 2014
Primær fullføring (Faktiske)
28. juni 2015
Studiet fullført (Faktiske)
30. september 2015
Datoer for studieregistrering
Først innsendt
5. mai 2014
Først innsendt som oppfylte QC-kriteriene
14. mai 2014
Først lagt ut (Anslag)
16. mai 2014
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
11. desember 2018
Siste oppdatering sendt inn som oppfylte QC-kriteriene
9. desember 2018
Sist bekreftet
1. desember 2018
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- TTYY-20131201
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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