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ISRCTN
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ISRCTN86935165
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ClinicalTrials.gov identifier
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Public title
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Measurement of, and psychological intervention with, partial adherence to inhaled antibiotic therapies in adults with cystic fibrosis
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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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N0436130480
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Study hypothesis
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1. To determine factors that affect adherence to nebuliser treatment in cystic fibrosis patients
2. To evaluate a psychological intervention designed to improve adherence in those whose adherence is less than 80%
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Lay summary
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Not provided at time of registration
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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 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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Nutritional, Metabolic, Endocrine: Cystic fibrosis
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Participants - inclusion criteria
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1. Male and female patients with a diagnosis of cystic fibrosis
2. 18+ years of age
3. Taking nebulised colistin through the ProDose Adaptive Aerosol Delivery (AAD) system for cystic fibrosis
4. Able to use a nebuliser mouthpiece
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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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01/03/2003
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Anticipated end date
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01/11/2006
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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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Not provided at time of registration
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Interventions
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Database analysis; Questionnaire; Randomised controlled trial ( psychological intervention versus no psychological intervention); Before-after trial.
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Primary outcome measure(s)
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1. The difference in adherence pre and post intervention. This will be measured using the ProDose adaptive aerosol delivery system, which records patient usage data
2. The relationship between adherence and clinical outcome such as forced expiratory volume (FEV1), use of additional antibiotic treatment and patients' own psychopathology (measured using questionnaires)
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Leeds Teaching Hospitals NHS Trust (UK)
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Trial website
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Publications
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1. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/18952395
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Contact name
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Miss
J E
Quinn
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Address
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Academic Unit Psychiatry & Behavioural Sciences
15 Hyde Terrace
University of Leeds
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City/town
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Leeds
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Zip/Postcode
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LS2 9LN
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Country
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United Kingdom
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Sponsor
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Record Provided by the NHSTCT Register - 2004 Update - Department of Health (UK)
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Address
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The Department of Health,
Richmond House,
79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.dh.gov.uk/Home/fs/en
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Date applied
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30/09/2004
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Last edited
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11/07/2011
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Date ISRCTN assigned
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30/09/2004
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