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Discharge Coordinator Intervention in Patients With Chronic Obstructive Pulmonary Disease (COPD)

8. april 2013 opdateret af: Mitja Lainščak, The University Clinic of Pulmonary and Allergic Diseases Golnik

Effects of Discharge Coordinator Intervention on Hospitalizations and Quality of Life in Patients With Chronic Obstructive Pulmonary Disease: a Randomized Controlled Clinical Trial

This is a single-centre randomized controlled clinical trial which will enroll COPD patients in Global Initiative for Chronic Obstructive Lung Disease (GOLD) stage II-IV, hospitalized due to acute exacerbation. Patients will be randomised in a 1:1 fashion to intervention group, which will have care organized by discharge coordinator, and control group which will receive care as usual. The primary endpoint of this study is time to hospitalization due to COPD worsening. Data will be collected at baseline, at the time of hospital discharge, and at following time-points after the hospital discharge: 48 hours, 7-10 days, 30 days, 90 days, and 180 days.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This is a single-centre randomized controlled clinical trial to assess the effectiveness of discharge coordinator intervention compared to care as usual in patients with COPD.

The study is being conducted at University Clinic of Pulmonary and Allergic Diseases Golnik, Slovenia. Patients with suspicion of acute exacerbation of COPD will be screened at admission when they will be informed about study details. After explanations of concerns and questions that they might have, a signed informed consent will be collected. During 48 hours, patients will be included according to their eligibility. Main inclusion criteria are COPD stage II-IV according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines, ability to perform phone contacts and availability for home visits. Patients will be excluded if in unstable or terminal stage of disease other than COPD, if they will die during hospitalization, or if unable to follow the study protocol.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

253

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Slovenien
      • Golnik, Slovenien, SI-4204
        • University Clinic Golnik

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

35 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • age >35 years
  • acute exacerbation of COPD stage II-IV
  • residence in the geographical area linked to the study hospital
  • ability to communicate
  • give written informed consent

Exclusion Criteria:

  • diagnosis of cognitive impairment
  • unstable or terminal disease other than COPD
  • withdrawal of written informed consent before discharge
  • inability of phone contact
  • death during hospitalisation

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Coordinated discharge
Patients will receive support by discharge coordinator for activities associated with discharge and immediate post-discharge care.
Andet: Coordinated discharge
In intervention group, a discharge coordinator contacts hospitalized patients the day after randomization. During hospitalization, discharge coordinator visits are scheduled according to patients' problems and home-care needs. At 48 hours after hospital discharge, a discharge coordinator calls patients by phone to check the process of adjustment to home environment and to inquire about additional needs patients might have. Thereafter, phone contacts are scheduled according to the patients' needs and 7-10 days after the hospital discharge a home visit is performed by discharge coordinator, respectively.
Placebo komparator: Control
Patients in control group will be managed by attending physician, primary care physician, and/or pneumologist in accordance with established clinical practice.
Andet: Control
Patients in control group will be managed by attending physician, primary care physician, and/or pneumologist in accordance with established clinical practice.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of patients hospitalized due to COPD worsening
Tidsramme: 180 days
A hospitalization is defined as an unplanned overnight stay in hospital (different date for admission and discharge) due to acute worsening of COPD. Endpoint will be adjudicated by Endpoint committee.
180 days

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
All-cause mortality
Tidsramme: 180 days
Mortality will be ascertained at the Central Population Registry.
180 days
Acute exacerbations of COPD
Tidsramme: 180 days
Endpoint will be adjudicated by Endpoint committee.
180 days
Time to hospitalization due to COPD worsening
Tidsramme: 180 days
A hospitalization is defined as an unplanned overnight stay in hospital (different date for admission and discharge) due to acute worsening of COPD. Endpoint will be adjudicated by Endpoint committee.
180 days
Days alive and out of hospital
Tidsramme: 180 days
Endpoint will be adjudicated by Endpoint committee.
180 days
Health-related quality of life
Tidsramme: 180 days
Endpoint will be adjudicated by Endpoint committee.
180 days
Health care costs
Tidsramme: 180 days
Endpoint will be adjudicated by Endpoint committee.
180 days

Samarbejdspartnere og efterforskere

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

Sponsor

The University Clinic of Pulmonary and Allergic Diseases Golnik

Efterforskere

  • Ledende efterforsker: Jerneja Farkas, MD, PhD, University of Ljubljana

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

1. november 2009

Primær færdiggørelse (Faktiske)

1. december 2011

Studieafslutning (Faktiske)

1. juni 2012

Datoer for studieregistrering

Først indsendt

18. oktober 2010

Først indsendt, der opfyldte QC-kriterier

20. oktober 2010

Først opslået (Skøn)

21. oktober 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

9. april 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. april 2013

Sidst verificeret

1. april 2013

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • Golnik-COPD-DC-1

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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Betingelser

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Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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