Treatment Adherence of Tuberculosis Medicines

Tuberculosis Clinical Trial

— TBAD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01471977
• Other study ID #: TB
• Status: Completed
• Phase: N/A
• First received: November 4, 2011
• Last updated: November 15, 2011
• Start date: January 2004
• Est. completion date: February 2010

Study information

• Verified date: November 2011
• Source: Gambat Institute of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Pakistan: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1280
• Est. completion date: February 2010
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Tuberculosis

Intervention

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

Locations

Country	Name	City	State
Pakistan	Basic Medical Unit of Taluka Gambat	Khairpur	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
Gambat Institute of Medical Sciences

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	8 months	No
Primary	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	8 months	No
Primary	Proportion of patients died	died during the course of treatment	8 months	No
Primary	proportion of patients defaulted	not collected drugs for more than 2 consecutive months either sputum smear positive or negative	8 months	No
Primary	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	8 months	No
Primary	proportion of patients transferred out	Transferred to another TB register	8 months	No