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TBAD: Treatment Adherence of Tuberculosis Medicines

Sponsor
Gambat Institute of Medical Sciences (Industry)
Overall Status
Completed
CT.gov ID
NCT01471977
Collaborator
(none)
1,280
Enrollment
1
Location
1
Arm
73
Duration (Months)
17.5
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: education,counseling, default tracers,quality of care
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
1280 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Interventions to Promote Adherence to Tuberculosis Treatment Among Patients Attending Basic Medical Unit of Taluka Gambat, Pakistan
Study Start Date :
Jan 1, 2004
Actual Primary Completion Date :
Dec 1, 2007
Actual Study Completion Date :
Feb 1, 2010

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Proportion of patients cured [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

    2. Proportion of patients completed treatment [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

    3. Proportion of patients died [8 months]

      died during the course of treatment

    4. proportion of patients defaulted [8 months]

      not collected drugs for more than 2 consecutive months either sputum smear positive or negative

    5. proportion of patients with treatment failure [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

    6. proportion of patients transferred out [8 months]

      Transferred to another TB register

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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:

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Basic Medical Unit of Taluka Gambat Khairpur Sindh Pakistan

    Sponsors and Collaborators

    • Gambat Institute of Medical Sciences

    Investigators

    • Principal Investigator: Nisar Sheikh, MBBS, GIMS

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Maliha Naseer, senior resident, Gambat Institute of Medical Sciences
    ClinicalTrials.gov Identifier:
    NCT01471977
    Other Study ID Numbers:
    • TB
    First Posted:
    Nov 16, 2011
    Last Update Posted:
    Nov 16, 2011
    Last Verified:
    Nov 1, 2011
    Additional relevant MeSH terms:
    Tuberculosis

    Study Results

    No Results Posted as of Nov 16, 2011