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NCT01390987 Clinical Trial

Access to Care and Adherence Tuberculosis (TB) Survey

Tuberculosis Clinical Trial

— TBsurvey  

Official title:
Survey Nazionale Sui Determinanti Del Ritardato Accesso Alle Cure e Della Mancata Aderenza al Trattamento Antitubercolare (National Survey on the Determinats of Delayed Access to Care and Non-adherence to Tuberculosis Treatment)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01390987
Other study ID # TBsurvey-001
Secondary ID
Status Completed
Phase N/A
First received July 7, 2011
Last updated January 17, 2014
Start date June 2011
Est. completion date December 2012

Study information
Verified date January 2014
Source Azienda Ospedaliera San Gerardo di Monza
Contact n/a
Is FDA regulated No
Health authority Italy: Ethics Committee
Study type Observational

Clinical Trial Summary

Prompt access to care and treatment adherence are the hearth of tuberculosis control.

This is a multicentre observational prospective study aimed at studying the factors associated with delayed access to care and low adherence to anti-tuberculosis treatment. Hetero- and self-administered questionnaires will be used at enrollment to assess clinical presentation and time and modalities of the diagnosis. Treatment adherence will be assessed during the follow-up with self administered questionnaires.

Recruitment information / eligibility
Status Completed
Enrollment 137
Est. completion date December 2012
Est. primary completion date September 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- >= 18 yrs of age

- recent new TB diagnosis

- Tuberculosis treatment prescribed

- Ability to sign the informed consent

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Italy Clinica di Malattie Infettive, Spedali Civili Brescia
Italy Clinica di Malattie Infettive, Ospedale San Martino Genova
Italy Clinica di Malattie Infettive, Ospedale Luigi Sacco Milano
Italy Clinic of Infectious Diseases, AO San Gerardo Monza MB
Italy Clinica di Malattie Infettive, Policlinico Gemelli Roma
Italy AO Fallacara Triggiano BA

Sponsors (1)
Lead Sponsor Collaborator
Azienda Ospedaliera San Gerardo di Monza

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Time to TB diagnosis Study enrollment No
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