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Main
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Note: This record shows only 22 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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16 December 2017 |
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Main ID: |
NCT03359915 |
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Date of registration:
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27/11/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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GECo: Implementation and Effectiveness of COPD Self Management Action Plans in Low and Middle Income Countries
GECo2 |
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Scientific title:
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Global Excellence in COPD Outcomes: Implementation and Effectiveness of COPD Self-Management Action Plans in Low and Middle Income Countries |
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Date of first enrolment:
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December 2017 |
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Target sample size:
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240 |
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Recruitment status: |
Not yet recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03359915 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Health Services Research. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Nepal
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Peru
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Uganda
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Contacts
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Name:
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John R Hurst, FRCP, PhD |
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Address:
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Telephone:
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+442074726260 |
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Email:
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j.hurst@ucl.ac.uk |
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Affiliation:
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Name:
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John R Hurst, FRCP, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University College, London |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Male or female participants aged =40 years
- Full-time resident in the area (living in area > 6 months)
- Able to perform adequate quality spirometry
- Capable of providing informed consent
- Identified as having COPD grade B-D as per GOLD criteria
Exclusion Criteria:
- Pregnancy (self-reported)
- Currently has active pulmonary TB or is taking medications for pulmonary TB
- Identified as having COPD grade A as per GOLD criteria
Age minimum:
40 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Chronic Obstructive Pulmonary Disease
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Intervention(s)
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Behavioral: COPD Self-Management Plan
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Primary Outcome(s)
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Change in SGRQ
[Time Frame: 12 months]
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Secondary Outcome(s)
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Number of Exacerbations
[Time Frame: 12 months]
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Number of CHW visits
[Time Frame: 12 months]
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Number of Hospitalisations
[Time Frame: 12 months]
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Health-Economics
[Time Frame: 12 months]
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Secondary ID(s)
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16/0630_RCT
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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