Access to Care and Adherence Tuberculosis (TB) Survey | NCT01390987

Studies
Access to Care and Adherence Tuberculosis (TB) Survey

NCT01390987

Sponsor

Azienda Ospedaliera San Gerardo di Monza

Status

Completed

Last Update Posted

Jan 20, 2014Estimated

Enrollment

137Actual

Phase

Not provided

Conditions

Tuberculosis

Interventions

Not provided

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2011

Primary Completion Date

Sep 2012Actual

Completion Date

Dec 2012Actual

First Submitted Date

Jul 7, 2011

First Submission Date that Met QC Criteria

Jul 8, 2011

First Posted Date

Jul 11, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 17, 2014

Last Update Posted Date

Jan 20, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Giuseppe Lapadula, MD, PhD, Azienda Ospedaliera San Gerardo di MonzaPrincipal Investigator

Lead Sponsor

Azienda Ospedaliera San Gerardo di MonzaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

137Actual

Measure	Description	Time Frame
Time to TB diagnosis		Study enrollment

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Giuseppe Lapadula, MD, PhD	Clinic of Infectious Disease, AO San Gerardo, Monza, Italy	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
AO Fallacara		Triggiano	BA		Italy
Clinic of Infectious Diseases, AO San Gerardo

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30572830	Derived	Peri AM, Bernasconi DP, Galizzi N, Matteelli A, Codecasa L, Giorgio V, Di Biagio A, Franzetti F, Cingolani A, Gori A, Lapadula G. Determinants of patient and health care services delays for tuberculosis diagnosis in Italy: a cross-sectional observational study. BMC Infect Dis. 2018 Dec 20;18(1):690. doi: 10.1186/s12879-018-3609-4.

ID	Term
D009164	Mycobacterium Infections
D000193	Actinomycetales Infections
D016908	Gram-Positive Bacterial Infections
D001424	Bacterial Infections