- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Golnik, Slowenien, SI-4204
- University Clinic Golnik
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Experimental: 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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Number of patients hospitalized due to COPD worsening
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
All-cause mortality
Zeitfenster: 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
Zeitfenster: 180 days
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Endpoint will be adjudicated by Endpoint committee.
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180 days
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Time to hospitalization due to COPD worsening
Zeitfenster: 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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Days alive and out of hospital
Zeitfenster: 180 days
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Endpoint will be adjudicated by Endpoint committee.
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180 days
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Health-related quality of life
Zeitfenster: 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
Zeitfenster: 180 days
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Endpoint will be adjudicated by Endpoint committee.
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180 days
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Mitarbeiter und Ermittler
Ermittler
- Hauptermittler: Jerneja Farkas, MD, PhD, University of Ljubljana
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- Golnik-COPD-DC-1
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