Treatment Adherence of Tuberculosis Medicines

Not Applicable

Completed

• Conditions: Tuberculosis
• Interventions: Other: education,counseling, default tracers,quality of care

• Registration Number: NCT01471977
• Lead Sponsor: Gambat Institute of Medical Sciences

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-01
• Primary Completion: 2007-12
• Study Completion: 2010-02
• Status Verified: 2011-11
• Study First Submitted: 2011-11-04
• Study First Submitted QC: 2011-11-15
• Last Update Submitted: 2011-11-15
• Study First Posted: 2011-11-16
• Last Update Posted: 2011-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1280

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

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
education, counselling, default tracer	education,counseling, default tracers,quality of care	-

Primary Outcome Measures

Name	Time	Method
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
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
Proportion of patients died	8 months	died during the course of treatment
proportion of patients defaulted	8 months	not collected drugs for more than 2 consecutive months either sputum smear positive or negative
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
proportion of patients transferred out	8 months	Transferred to another TB register

Trial Locations

Locations (1)

Basic Medical Unit of Taluka Gambat; 🇵🇰 Khairpur, Sindh, Pakistan