- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01108835
A Comprehensive Care Programme for Patients With Chronic Obstructive Pulmonary Disease
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Design: A randomised controlled trial of patients discharged from hospital after an episode of acute exacerbation of COPD. Patients will be randomised to the intervention arm or usual care group.
Setting: Tertiary University affiliated Hospital.
Interventions:
The Intervention group will receive a comprehensive programme which involves inputs from doctors, respiratory nurses and physiotherapists, providing an individualized care plan for each subject. The components in the programme will include optimization of medications, specialist physician follow up, nursing support in education, and physiotherapist support for pulmonary rehabilitation. Patients in the intervention group will also receive monthly telephone calls by a respiratory nurse for a period of 1 year to assess their conditions and answer their queries. Patients will also be followed up in the respiratory clinic by respiratory specialist once every 3 months for 1 year.
The control group will be managed as the usual care. The discharging physician will determine the patients' medication and follow up as in normal practice.
All patients will be asked to return for assessments (spirometry, 6 minute walk test, questionnaires on the severity of dyspnoea and quality of life) at baseline and 12 months
Main outcome measures: The primary endpoint is the hospital readmission rate and the secondary endpoints are the quality of life, mortality, lung function and exercise capacity of the patients.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Hong Kong, Hong Kong
- The Chinese University of Hong Kong
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Patients who are admitted to the Prince of Wales Hospital with AECOPD will be screened for this study.
- Patients with age over 40 years
Exclusion Criteria:
- Patients with asthma
- Patients unable to provide informed consent
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: comprehensive care programme
Comprehensive care involving multidisciplinary input.
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Intervention group:
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Ingen indgriben: Control group
Control arm with usual care
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Hospital Readmission
Tidsramme: 12 months
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To investigate the effectiveness of a comprehensive care programme in reducing hospital admission in COPD patients who have been discharged from hospital for an episode of AECOPD.
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12 months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Quality of Life
Tidsramme: 12 months
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Measured by change in St. George Respiratory Questionnaire (SGRQ) total score from baseline to 12 month.
SGRQ total score ranged from 0-100.
The change was calculated by the 12 month SGRQ total score minus the baseline value.
Negative values indicated improvement in quality of life.
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12 months
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Mortality
Tidsramme: 12 months
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From contacting the patient/their family and hospital record retrieval.
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12 months
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Lung Function
Tidsramme: 12 months
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Measurement of change of spirometry (FEV1 % predicted) from baseline to 12 month.
The range is from 0% to 100%.
The change was calculated by 12 month value minus the baseline value.
Positive value indicated improvement in lung function.
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12 months
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Exercise Capacity
Tidsramme: 12 month
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Exercise capacity was measured by change in 6 minutes walk test distance from baseline to 12 month.
6 minute walk test is the distance that the patient can walk over 6 minutes and it can range to 0 meters to few hundred meters.
This was calculated by the 12 month 6 minutes walk test distance minus that of the baseline.
Positive values indicated improvement in exercise capacity.
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12 month
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: David S Hui, MD, Chinese University of Hong Kong
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Resp/Ko/2010/001
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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