Secondary Prevention and Health Promotion After Stroke
22. januar 2014 oppdatert av: Ann-Cathrin Jonsson, Skane University Hospital
Secondary Prevention and Health Promotion After Stroke A Nurse-led Randomized Controlled Open Trial
The aim of this study was to examine to what extent a one year population of stroke patients at a university hospital had well regulated risk factors and health problems one year after stroke, and if a structured nurse-led previous follow-up in the intervention group including referrals if needed could influence health outcome and risk factors one year after stroke.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
The follow-up protocol was categorized into Risk factors, Patients' self-reports, and Other health problems.
Referral was sent to a physician if medical interventions were needed regarding risk factors measured above the limits as stated in the follow-up protocol in accordance with guidelines,and/or if any self-reported health problems were stated by the patients, or had been detected by the Specialist Nurse.
Primary outcome was comparison between the intervention group and control group at one year after stroke regarding proportion of regulated risk factors, and self-reports on health outcome.
Results of the two follow-ups of the intervention group were also compared.
Studietype
Intervensjonell
Registrering (Faktiske)
597
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
-
Malmö, Sverige, 205 02
- Skåne University Hospital
-
-
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
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
WHO criteria for definition of stroke Signed consent
Exclusion Criteria:
Other diagnosis causing neurological symptoms
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: Intervention group
Control of secondary prevention at three months and one year after stroke and referral to physician if medical interventions are needed.
Assessment of functional status and self-reports on health outcome.
Supportive counselling provided.
|
Patients' self-reports on Mobility, Self Care, Usual activities, Pain/Discomfort, Anxiety/Depression, Health Outcome were registered.
Health problems were assessed.
Secondary prevention was controlled by measuring blood pressure, Cholesterol levels, HbA1c, Weight to estimate nutritional status.
Functional status was assessed.
Supportive counselling was provided.
Referral was sent to physician if medical interventions were needed.
|
|
Annen: Control group
Standard care with no outlined follow-up until one year after stroke.
Control of secondary prevention after one year after stroke and referral to physician if medical interventions are needed.
Follow-up one year after stroke according to the same protocol as the intervention group.
|
No intervention three months after stroke.
Assessment one year after stroke and comparison with the intervention group.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Risk factors and health outcome compared between intervention group and control group
Tidsramme: Baseline to one year after stroke for both groups.
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Outcome for both groups after one year was measured as the proportion of risk factors sufficiently treated, the patients' self-reports on health outcome and comparison between the intervention group and the control group.
|
Baseline to one year after stroke for both groups.
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Risk factors and health outcome at two follow-ups.
Tidsramme: Baseline to one year after stroke
|
Comparison of health outcome at three months and one year after stroke in the intervention group.
|
Baseline to one year after stroke
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Ann-Cathrin Jönsson, PhD, Department of Health Sciences, Lund University
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
1. februar 2008
Primær fullføring (Faktiske)
1. februar 2010
Studiet fullført (Faktiske)
1. april 2010
Datoer for studieregistrering
Først innsendt
4. november 2011
Først innsendt som oppfylte QC-kriteriene
4. november 2011
Først lagt ut (Anslag)
8. november 2011
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
23. januar 2014
Siste oppdatering sendt inn som oppfylte QC-kriteriene
22. januar 2014
Sist bekreftet
1. januar 2014
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- MaStrokeFup0809
- UMASNL (Annen identifikator: Regional Ethical Review Board DNr 520/2007)
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