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ISRCTN
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ISRCTN55381079
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ClinicalTrials.gov identifier
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Public title
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A randomised cross over trial of nurse versus doctor-led outpatient care in a bronchiectasis clinic
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Scientific title
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Acronym
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N/A
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Serial number at source
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HTA 94/40/27
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Study hypothesis
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1. To assess the feasibility and safety of nurse led outpatient clinics.
2. To evaluate the acceptability of nurse led outpatient clinics to patients and GPs.
3. To compare the cost effectiveness of a nurse led and doctor led system of care. This is a cross over study of nurse led repeat visits for patients with bronchiectasis, following initial investigation and establishment of a care plan by a consultant physician. The initial phase (9-12 months) is essential to allow training of the nurse practitioner, and introduction of this concept to patients and general practitioners.
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Ethics approval
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Not provided at time of registration.
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Study design
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Randomised controlled cross-over trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Respiratory tract diseases: Other respiratory tract disease
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Participants - inclusion criteria
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Patients over 18 years with moderate or severe bronchiectasis confirmed by high resolution computed tomography scans.
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Participants - exclusion criteria
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Not provided at time of registration.
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Anticipated start date
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01/07/1997
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Anticipated end date
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30/11/2000
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Status of trial
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Completed
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Patient information material
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Target number of participants
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80
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Interventions
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For the first year of the study patients were randomised to receive either 1 year of nurse practitioner-led care or 1 year of doctor led care. The 2 groups then crossed over to receive the alternate mode of care for a further year. It was important the subjects received each mode of care for a whole year because chronic lung disease is subject to seasonal variation.
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Primary outcome measure(s)
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Primary outcome was lung function as measured by forced expiratory volume in 1 second (FEV1).
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Secondary outcome measure(s)
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Secondary measures included walking distance, health related quality of life, nurse practitioner autonomy, patient and general practitioner satisfaction with communications and care, patient compliance with treatment and resource group
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Sources of funding
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NIHR Health Technology Assessment Programme - HTA (UK)
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Trial website
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Publications
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1. Monograph on http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=12433318
2. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=12149523
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Contact name
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Dr
Diana
Bilton
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Address
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Cystic Fibrosis and Lung Defence Unit
Papworth Hospital NHS Trust
Papworth Everard
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City/town
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Cambridge
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Zip/Postcode
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CB3 8RE
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Country
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United Kingdom
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Tel
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+44 (0)1480 830 541 Ext 4697
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Fax
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+44 (0)1480 364 330
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Email
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drdianabilton@cs.com
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Sponsor
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Department of Health (UK)
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Address
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Quarry House
Quarry Hill
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City/town
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Leeds
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Zip/Postcode
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LS2 7UE
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Country
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United Kingdom
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Email
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Sheila.Greener@doh.gsi.gov.uk
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Sponsor website:
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http://www.dh.gov.uk/en/index.htm
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Date applied
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25/04/2003
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Last edited
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16/01/2008
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Date ISRCTN assigned
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25/04/2003
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