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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01513980 |
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Date of registration:
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17/01/2012 |
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Primary sponsor: |
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Public title:
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Life-long Monitoring of COPD in Veneto Region
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Scientific title:
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RENEWING HEALTH - Large Scale Pilot in Veneto Region: Life-long Monitoring in COPD |
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Date of first enrolment:
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November 2011 |
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Target sample size:
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750 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01513980 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care
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Countries of recruitment
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Italy
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Contacts
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Name:
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Massimo Fusello, MD |
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Address:
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Telephone:
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041 2608805 |
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Email:
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Massimo.Fusello@ulss12.ve.it |
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Affiliation:
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Name:
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Massimo Fusello, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Local Health authority Veneziana |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Age = 18 years.
- COPD GOLD class 3-4
- Life expectance > 12 months
Exclusion Criteria:
• Patient unable to use the equipment provided (alone or assisted).
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Pulmonary Disease, Chronic Obstructive
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Intervention(s)
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Other: Usual care
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Procedure: nurse-monitoring for patients with severe COPD
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Procedure: self-monitoring for patients with severe COPD
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Primary Outcome(s)
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Health-Related quality of life
[Time Frame: 12 months]
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Secondary Outcome(s)
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All cause mortality
[Time Frame: 12 months]
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Anxiety and depression status
[Time Frame: 12 months]
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Number of bed days for hospitalised patients
[Time Frame: 12 months]
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Number of re-hospitalizations
[Time Frame: 12 months]
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Number of specialist visits
[Time Frame: 12 months]
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Number of visits to emergency department
[Time Frame: 12 months]
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Secondary ID(s)
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G. A. 250487-Veneto WP8Cl5
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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