Can Screening People Registering With Primary Care Improve the Detection of Tuberculosis?

NCT00214708 | Withdrawn

• 1 other identifier: TB-02-04-CG
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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. 2.implement a screening programme comprising education, resources and clinical support for intervention practices using proven behaviour change strategies
3. 3.gather outcomes and costs
4. 4.build research capacity within an ELENoR Primary Care Research Team and across a Primary Care Trust.

Conditions

Tuberculosis

Keywords

Tuberculosis; Screening; Heaf; BCG

Outcome Measures

Primary Outcomes (1)

• 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 (1)

• 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.

Interventions

Screening for Tuberculosis PROCEDURE

Eligibility Criteria

• Age: Up to 105 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• The intervention is screening for TB in general practices which were randomised to control or intervention

You may not qualify if:

• Practices that refused to participate could not be included. We excluded the general practice where the pilot study was undertaken

Sponsors & Collaborators

• Barts & The London NHS Trust: lead
• NHS Research and Development: collaborator

Study Sites (1)

City and Hackney

London, E9, United Kingdom

Location

Related Publications (1)

• Griffiths C, Sturdy P, Brewin P, Bothamley G, Eldridge S, Martineau A, MacDonald M, Ramsay J, Tibrewal S, Levi S, Zumla A, Feder G. Educational outreach to promote screening for tuberculosis in primary care: a cluster randomised controlled trial. Lancet. 2007 May 5;369(9572):1528-1534. doi: 10.1016/S0140-6736(07)60707-7.

  PMID: 17482983 DERIVED

MeSH Terms

Conditions

Tuberculosis

Interventions

Mass Screening

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Diagnostic Services; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Practice

Study Officials

• Chris J Griffiths, DPhil, MB BS

  Queen Mary University of London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 16, 2005
• First Posted: September 22, 2005
• Study Start: January 1, 2002
• Primary Completion: September 1, 2002
• Study Completion: September 1, 2002
• Last Updated: February 6, 2025

Record last verified: 2025-02

Locations

GB (1)