Tuberculosis Clinical Trial
Official title:
Can Screening People Registering With Primary Care Improve the Detection of Tuberculosis? A Cluster Randomised Controlled Trial in an East London Primary Care Trust
Verified date | September 2005 |
Source | Barts & The London NHS Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | United Kingdom: National Health Service |
Study type | Observational |
This randomised controlled trial tests whether screening people registering with general
practices cost-effectively increases the detection of tuberculosis. The study objectives are
to:
1. recruit, and randomise with stratification, forty Hackney general practices to usual
activity or screening for TB primarily during registration health checks (by practice
nurses and GPs) and transfer-in visits for children (by health visitors)
2. implement a screening programme comprising education, resources and clinical support
for intervention practices using proven behaviour change strategies
3. gather outcomes and costs
4. build research capacity within an ELENoR Primary Care Research Team and across a
Primary Care Trust.
The primary outcome is the proportion of TB cases identified in primary care. The study is
powered to detect a 20% increase (from 55% to 75%) in the detection of new cases of TB in
primary care with 80% power at the 5% significance level. Secondary outcomes are rates of
prophylaxis for latent TB infection (LTBI), BCG immunisation, smear negative (early) TB and
costs. Analyses will be by intention to treat.
Status | Active, not recruiting |
Enrollment | 200 |
Est. completion date | September 2004 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: The intervention is screening for TB in general practices which were randomised to control or intervention Exclusion Criteria: Practices that refused to participate could not be included. We excluded the general practice where the pilot study was undertaken |
Observational Model: Defined Population, Primary Purpose: Screening, Time Perspective: Longitudinal
Country | Name | City | State |
---|---|---|---|
United Kingdom | City and Hackney | London |
Lead Sponsor | Collaborator |
---|---|
Barts & The London NHS Trust | NHS Research and Development |
United Kingdom,
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