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

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ClinicalTrials.gov Identifier: NCT01390987
Recruitment Status : Completed
First Posted : July 11, 2011
Last Update Posted : January 20, 2014
Sponsor:
Information provided by (Responsible Party):
Giuseppe Lapadula, Azienda Ospedaliera San Gerardo di Monza

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.


Condition or disease
Tuberculosis

Study Type : Observational
Actual Enrollment : 137 participants
Observational Model: Cohort
Time Perspective: Prospective
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)
Study Start Date : June 2011
Actual Primary Completion Date : September 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis




Primary Outcome Measures :
  1. Time to TB diagnosis [ Time Frame: Study enrollment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All new tuberculosis (any site) diagnosed in the study time-frame, regardless of previous treatment history.
Criteria

Inclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01390987


Locations
Italy
AO Fallacara
Triggiano, BA, Italy
Clinic of Infectious Diseases, AO San Gerardo
Monza, MB, Italy, 20900
Clinica di Malattie Infettive, Spedali Civili
Brescia, Italy, 25126
Clinica di Malattie Infettive, Ospedale San Martino
Genova, Italy
Clinica di Malattie Infettive, Ospedale Luigi Sacco
Milano, Italy
Clinica di Malattie Infettive, Policlinico Gemelli
Roma, Italy
Sponsors and Collaborators
Azienda Ospedaliera San Gerardo di Monza
Investigators
Principal Investigator: Giuseppe Lapadula, MD, PhD Clinic of Infectious Disease, AO San Gerardo, Monza, Italy

Responsible Party: Giuseppe Lapadula, MD, PhD, Azienda Ospedaliera San Gerardo di Monza
ClinicalTrials.gov Identifier: NCT01390987     History of Changes
Other Study ID Numbers: TBsurvey-001
First Posted: July 11, 2011    Key Record Dates
Last Update Posted: January 20, 2014
Last Verified: January 2014

Additional relevant MeSH terms:
Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections