Treatment Adherence of Tuberculosis Medicines (TBAD)

November 15, 2011 updated by: Maliha Naseer, Gambat Institute of Medical Sciences

Interventions to Promote Adherence to Tuberculosis Treatment Among Patients Attending Basic Medical Unit of Taluka Gambat, Pakistan

It was hypothesized that tuberculosis patients receiving multiple interventions like educations, counseling and default tracing along with DOTS were more likely to adhere to tuberculosis treatment as compared to few interventions or DOTS only.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1280

Phase

  • Not Applicable

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

  • Pakistan
    • Sindh
      • Khairpur, Sindh, Pakistan
        • Basic Medical Unit of Taluka Gambat

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

Description

Inclusion Criteria:

  • adult patient
  • > 18years
  • either sex
  • diagnosed to have tuberculosis through chest x ray or sputum microscopy
  • eligible to participate in the study

Exclusion Criteria:

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

  • Primary Purpose: PREVENTION
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: education, counselling, default tracer
Other: education,counseling, default tracers,quality of care
these interventions were administered along with standard treatment i.e. DOTS at the time of standard follow up of patients at clinic
Other Names:
  • tuberculosis
  • directly observed short course treatment
  • education and counseling
  • default tracer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients cured
Time Frame: 8 months
Cured: If the patient was sputum smear positive (ss+ve) at the time of enrollment, completed treatment, Had negative smear on 2 occasions during follow-up
8 months
Proportion of patients completed treatment
Time Frame: 8 months
Treatment completed: SS+ve, or SS-ve or extra-pulmonary, had a negative smear result at the end of intensive phase but no smear result at the end of treatment completed 8 month treatment
8 months
Proportion of patients died
Time Frame: 8 months
died during the course of treatment
8 months
proportion of patients defaulted
Time Frame: 8 months
not collected drugs for more than 2 consecutive months either sputum smear positive or negative
8 months
proportion of patients with treatment failure
Time Frame: 8 months
Treatment failure: SS+ve, found to be smear positive at 5th month or later or SS-ve found to be smear positive at 2nd month
8 months
proportion of patients transferred out
Time Frame: 8 months
Transferred to another TB register
8 months

Collaborators and Investigators

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

Sponsor

Gambat Institute of Medical Sciences

Investigators

  • Principal Investigator: Nisar Sheikh, MBBS, GIMS

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

January 1, 2004

Primary Completion (ACTUAL)

December 1, 2007

Study Completion (ACTUAL)

February 1, 2010

Study Registration Dates

First Submitted

November 4, 2011

First Submitted That Met QC Criteria

November 15, 2011

First Posted (ESTIMATE)

November 16, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

November 16, 2011

Last Update Submitted That Met QC Criteria

November 15, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TB

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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