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

January 17, 2014 updated by: Giuseppe Lapadula, Azienda Ospedaliera San Gerardo di Monza

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)

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

137

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Brescia, Italy, 25126
        • Clinica di Malattie Infettive, Spedali Civili
      • Genova, Italy
        • Clinica di Malattie Infettive, Ospedale San Martino
      • Milano, Italy
        • Clinica di Malattie Infettive, Ospedale Luigi Sacco
      • Roma, Italy
        • Clinica di Malattie Infettive, Policlinico Gemelli
    • BA
      • Triggiano, BA, Italy
        • AO Fallacara
    • MB
      • Monza, MB, Italy, 20900
        • Clinic of Infectious Diseases, AO San Gerardo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to TB diagnosis
Time Frame: Study enrollment
Study enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Ospedaliera San Gerardo di Monza

Investigators

  • Principal Investigator: Giuseppe Lapadula, MD, PhD, Clinic of Infectious Disease, AO San Gerardo, Monza, Italy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

July 7, 2011

First Submitted That Met QC Criteria

July 8, 2011

First Posted (Estimate)

July 11, 2011

Study Record Updates

Last Update Posted (Estimate)

January 20, 2014

Last Update Submitted That Met QC Criteria

January 17, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TBsurvey-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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