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

This study has been completed.
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: January 17, 2014
Last verified: January 2014
  Purpose

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
Tuberculosis

Study Type: Observational
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Azienda Ospedaliera San Gerardo di Monza:

Primary Outcome Measures:
  • Time to TB diagnosis [ Time Frame: Study enrollment ] [ Designated as safety issue: No ]

Enrollment: 137
Study Start Date: June 2011
Study Completion Date: December 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: July 7, 2011
Last Updated: January 17, 2014
Health Authority: Italy: Ethics Committee

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

ClinicalTrials.gov processed this record on July 31, 2014