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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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PACTR |
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Last refreshed on:
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29 May 2023 |
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Main ID: |
PACTR201411000910192 |
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Date of registration:
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13/10/2014 |
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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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Triage Plus
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Scientific title:
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Informal Health Provider and Practical Approach to Lung Health interventions to improve the detection of chronic airways disease and tuberculosis at primary care level in Malawi: A cluster level randomized controlled trial |
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Date of first enrolment:
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01/01/2015 |
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Target sample size:
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27000 |
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Recruitment status: |
Pending |
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URL:
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https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=910 |
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Study type:
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Interventional |
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Study design:
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Parallel: different groups receive different interventions at same time during study,Randomised,Computer-generated randomization schedule with stratification by size of cluster,Allocation was determined by the holder of the sequence who is situated off site
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Phase:
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Not Applicable
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Countries of recruitment
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Malawi
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Contacts
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Name:
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Hastings
Banda |
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Address:
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Research for Equity & Community Health Trust, Off Paul Kagame Rd, Area 6,Plot6/28
Lilongwe
Malawi |
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Telephone:
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+2651753260 |
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Email:
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hastings@reachtrust.org |
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Affiliation:
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Name:
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Hastings
Banda |
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Address:
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Off Paul Kagame Rd, rea 6, Plot 6/28
Lilongwe
Malawi |
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Telephone:
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+2651753260 |
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Email:
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hastings@reachtrust.org |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Inclusion criteria for health facilities
1. Health facilities that offer out-patient services only
2. Run by low low/middle level health care workers
Exclusion criteria: Exclusion criteria
1. Health facilities offering in-patient services
2. Health facilities run by qualified medical doctors
Age minimum:
15 Year(s)
Age maximum:
120 Year(s)
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Tuberculosis
Chronic cough
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Chronic cough
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Tuberculosis
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Intervention(s)
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Intervention arm II
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Standard of care
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Intervention arm 1
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Primary Outcome(s)
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1.Proportion of the population with a chronic cough who have a diagnosis of TB or airway disease(s) recorded in their health passports
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Secondary Outcome(s)
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Proportion of people with disabilities with a diagnosis of TB or airway disease recorded in their health passports in all arms of the study.
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Proportion of the population with a chronic cough on salbutamol / corticosteroid inhaler indicated in their health passports
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Proportion of the population with a chronic cough with a diagnosis of TB or airway disease among patients with chronic cough attending primary health care recorded in patient registers at intervention facilities.
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Source(s) of Monetary Support
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Norwegian Heart and Lung Patient Association (LHL) International Tuberculosis Foundation (LHL International) and the Norwegian Government (NORAD)
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Ethics review
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Status: Approved
Approval date: 27/09/2013
Contact:
College of Medicine Research Ethics Committee
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Status: Approved
Approval date: 22/07/2014
Contact:
Liverpool School of Tropical Medicine Research Ethics Committee
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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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