Back to resultsTreatment Adherence of Tuberculosis Medicines (TBAD)
Primary Purpose
Tuberculosis
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
education,counseling, default tracers,quality of care
Sponsored by
About this trial
This is an interventional prevention trial for Tuberculosis
Eligibility Criteria
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:
Sites / Locations
- Basic Medical Unit of Taluka Gambat
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
education, counselling, default tracer
Arm Description
Outcomes
Primary Outcome Measures
Proportion of patients cured
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
Proportion of patients completed treatment
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
Proportion of patients died
died during the course of treatment
proportion of patients defaulted
not collected drugs for more than 2 consecutive months either sputum smear positive or negative
proportion of patients with treatment failure
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
proportion of patients transferred out
Transferred to another TB register
Secondary Outcome Measures
Full Information
NCT ID
NCT01471977
First Posted
November 4, 2011
Last Updated
November 15, 2011
Sponsor
Gambat Institute of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT01471977
Brief Title
Treatment Adherence of Tuberculosis Medicines
Acronym
TBAD
Official Title
Interventions to Promote Adherence to Tuberculosis Treatment Among Patients Attending Basic Medical Unit of Taluka Gambat, Pakistan
Study Type
Interventional
2. Study Status
Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
February 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gambat Institute of Medical Sciences
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tuberculosis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1280 (Actual)
8. Arms, Groups, and Interventions
Arm Title
education, counselling, default tracer
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
education,counseling, default tracers,quality of care
Other Intervention Name(s)
tuberculosis, directly observed short course treatment, education and counseling, default tracer
Intervention Description
these interventions were administered along with standard treatment i.e. DOTS at the time of standard follow up of patients at clinic
Primary Outcome Measure Information:
Title
Proportion of patients cured
Description
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
Time Frame
8 months
Title
Proportion of patients completed treatment
Description
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
Time Frame
8 months
Title
Proportion of patients died
Description
died during the course of treatment
Time Frame
8 months
Title
proportion of patients defaulted
Description
not collected drugs for more than 2 consecutive months either sputum smear positive or negative
Time Frame
8 months
Title
proportion of patients with treatment failure
Description
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
Time Frame
8 months
Title
proportion of patients transferred out
Description
Transferred to another TB register
Time Frame
8 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nisar Sheikh, MBBS
Organizational Affiliation
GIMS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Basic Medical Unit of Taluka Gambat
City
Khairpur
State/Province
Sindh
Country
Pakistan
12. IPD Sharing Statement
Learn more about this trial
Treatment Adherence of Tuberculosis Medicines
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