Access to Care and Adherence Tuberculosis (TB) Survey (TBsurvey)

This study is currently recruiting participants.

Verified February 2012 by Azienda Ospedaliera San Gerardo di Monza

Sponsor:

Information provided by (Responsible Party):

Giuseppe Lapadula, Azienda Ospedaliera San Gerardo di Monza

ClinicalTrials.gov Identifier:

NCT01390987

First received: July 7, 2011

Last updated: February 8, 2012

Last verified: February 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

July 7, 2011

Last Updated Date

February 8, 2012

Start Date ^ICMJE

June 2011

Estimated Primary Completion Date

July 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT01390987 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Access to Care and Adherence Tuberculosis (TB) Survey

Official Title ^ICMJE

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)

Brief 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.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

All new tuberculosis (any site) diagnosed in the study time-frame, regardless of previous treatment history.

Condition ^ICMJE

Tuberculosis

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

200

Completion Date

Not Provided

Estimated Primary Completion Date

July 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

>= 18 yrs of age
recent new TB diagnosis
Tuberculosis treatment prescribed
Ability to sign the informed consent

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Giuseppe Lapadula

+390392339320

g.lapadula@hsgerardo.org

Location Countries ^ICMJE

Italy

Administrative Information

NCT Number ^ICMJE

NCT01390987

Other Study ID Numbers ^ICMJE

TBsurvey-001

Has Data Monitoring Committee

Responsible Party

Giuseppe Lapadula, Azienda Ospedaliera San Gerardo di Monza

Study Sponsor ^ICMJE

Azienda Ospedaliera San Gerardo di Monza

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Giuseppe Lapadula, MD, PhD

Clinic of Infectious Disease, AO San Gerardo, Monza, Italy

Information Provided By

Azienda Ospedaliera San Gerardo di Monza

Verification Date

February 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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