- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01225627
Discharge Coordinator Intervention in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Effects of Discharge Coordinator Intervention on Hospitalizations and Quality of Life in Patients With Chronic Obstructive Pulmonary Disease: a Randomized Controlled Clinical Trial
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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-
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Golnik, Slovenia, SI-4204
- University Clinic Golnik
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Coordinated discharge
Patients will receive support by discharge coordinator for activities associated with discharge and immediate post-discharge care.
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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.
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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.
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Patients in control group will be managed by attending physician, primary care physician, and/or pneumologist in accordance with established clinical practice.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Number of patients hospitalized due to COPD worsening
Tidsramme: 180 days
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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.
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180 days
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
All-cause mortality
Tidsramme: 180 days
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Mortality will be ascertained at the Central Population Registry.
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180 days
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Acute exacerbations of COPD
Tidsramme: 180 days
|
Endpoint will be adjudicated by Endpoint committee.
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180 days
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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.
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180 days
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Days alive and out of hospital
Tidsramme: 180 days
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Endpoint will be adjudicated by Endpoint committee.
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180 days
|
Health-related quality of life
Tidsramme: 180 days
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Endpoint will be adjudicated by Endpoint committee.
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180 days
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Health care costs
Tidsramme: 180 days
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Endpoint will be adjudicated by Endpoint committee.
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180 days
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Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Jerneja Farkas, MD, PhD, University of Ljubljana
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Golnik-COPD-DC-1
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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