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ISRCTN
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ISRCTN33946398
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ClinicalTrials.gov identifier
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Public title
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A randomised prospective controlled study to assess the effects of a respiratory case management model on hospital readmission rates in patients with moderate to severe chronic obstructive pulmonary disease
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Scientific title
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Acronym
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EXHALE (Exercise, Home support and Lung Education)
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Serial number at source
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N/A
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Study hypothesis
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Whether intensive education, support and individualised exercise programme can reduce hospital admissions in patients with moderate to severe Chronic Obstructive Pumonary Disease (COPD).
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Ethics approval
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Added 18/03/10:
Sefton Research and Ethics Committee. Ref: 04/Q1501/75, September 2004.
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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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Chronic Obstructive Pulmonary Disease
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Participants - inclusion criteria
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1. Patients with moderate to severe COPD confirmed on spirometry
2. Aged 40 years or more who have had one or more admission to hospital in last 12 months
3. Must be current or ex-smokers
4. Must have home telephone
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Participants - exclusion criteria
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1. Patients with previous diagnosis of asthma
2. Significant/unstable cardiac dysfunction
3. Underlying malignancy, dementia or major psychiatric illness
4. Participation in pulmonary rehabillitation in last 12 months
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Anticipated start date
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01/10/2004
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Anticipated end date
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30/09/2006
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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270
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Interventions
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Case management model of care: weekly home visits and small group exercise sessions for eight weeks. Monthly visits thereafter, with weekly, then fortnightly phone calls. Dedicated telephone support seven days a week for 12 months.
Control group have usual care.
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Primary outcome measure(s)
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Number of hospital admissions for COPD at 12 months.
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Secondary outcome measure(s)
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1. Quality of life/health status
2. Exercise capacity, lung function, and treatment over a one year period
3. Total number and length of hospital admissions for any cause
4. Number of General Practitioner visits, accident and emergency department visits over the 12 month follow up
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Sources of funding
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South Sefton Primary Care Trust (in collaboration with Liverpool and Knowsley Primary Care Trusts) (UK)
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Trial website
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Publications
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Contact name
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Dr
Lisa
Davies
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Address
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Aintree Chest Centre
University Hospital Aintree
Lower Lane
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City/town
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Liverpool
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Zip/Postcode
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L9 7AL
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Country
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United Kingdom
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Tel
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+44 (0)151 529 3796
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Fax
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+44 (0)151 529 2873
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Email
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lisa.davies@aintree.nhs.uk
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Sponsor
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University Hospital Aintree (UK)
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Address
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Lower Lane
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City/town
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Liverpool
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Zip/Postcode
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L9 7AL
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Country
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United Kingdom
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Tel
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+44 (0)151 529 3796
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Fax
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+44 (0)151 529 2873
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Email
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lisa.davies@aintree.nhs.uk
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Date applied
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13/09/2005
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Last edited
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18/03/2010
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Date ISRCTN assigned
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27/09/2006
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