NCT01471977

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,280

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

November 4, 2011

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 16, 2011

Completed
Last Updated

November 16, 2011

Status Verified

November 1, 2011

Enrollment Period

3.9 years

First QC Date

November 4, 2011

Last Update Submit

November 15, 2011

Conditions

Tuberculosis

Outcome Measures

Primary Outcomes (6)

  • 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

  • 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

  • Proportion of patients died

    died during the course of treatment

    8 months

  • proportion of patients defaulted

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

    8 months

  • 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

  • proportion of patients transferred out

    Transferred to another TB register

    8 months

Study Arms (1)

education, counselling, default tracer

EXPERIMENTAL
Other: education,counseling, default tracers,quality of care

Interventions

education,counseling, default tracers,quality of careOTHER

these interventions were administered along with standard treatment i.e. DOTS at the time of standard follow up of patients at clinic

Also known as: tuberculosis, directly observed short course treatment, education and counseling, default tracer
education, counselling, default tracer

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Basic Medical Unit of Taluka Gambat

Khairpur, Sindh, Pakistan

Location

MeSH Terms

Conditions

Tuberculosis

Interventions

Educational StatusCounseling

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation CharacteristicsMental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Nisar Sheikh, MBBS

    GIMS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
senior resident

Study Record Dates

First Submitted

November 4, 2011

First Posted

November 16, 2011

Study Start

January 1, 2004

Primary Completion

December 1, 2007

Study Completion

February 1, 2010

Last Updated

November 16, 2011

Record last verified: 2011-11

Locations

PA(1)