TuberculosisTBADNCT01471977
Treatment Adherence of Tuberculosis Medicines
A study testing education,counseling, default tracers,quality of care in people with Tuberculosis, run by Gambat Institute of Medical Sciences at 1 site in Pakistan.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tuberculosis
- What is being tested?
- education,counseling, default tracers,quality of care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,280 participants
- Where
- 1 sitePakistan
- Study dates
- Jan 2004to Feb 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patient
- > 18years
- either sex
- diagnosed to have tuberculosis through chest x ray or sputum microscopy
- eligible to participate in the study
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interventions to Promote Adherence to Tuberculosis Treatment Among Patients Attending Basic Medical Unit of Taluka Gambat, Pakistan
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.
- Conditions
- Tuberculosis
- Being tested
- education,counseling, default tracers,quality of care
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
education,counseling, default tracers,quality of careOther
Also called tuberculosis, directly observed short course treatment, education and counseling, default tracer
these interventions were administered along with standard treatment i.e. DOTS at the time of standard follow up of patients at clinic
| Study group | Role | What they receive |
|---|---|---|
| education, counselling, default tracer | Experimental | Not described Receives: Other: education,counseling, default tracers,quality of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 8 months
Proportion of patients died
died during the course of treatment
Measured: 8 months
proportion of patients defaulted
not collected drugs for more than 2 consecutive months either sputum smear positive or negative
Measured: 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
Measured: 8 months
proportion of patients transferred out
Transferred to another TB register
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2011 (estimated)
- Study startJan 2004
- Primary completionDec 2007
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,280 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gambat Institute of Medical Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Maliha Naseer, Gambat Institute of Medical Sciences
- Investigators
- Nisar Sheikh, MBBS, Principal investigator, GIMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01471977
- Sponsor's protocol ID
- TB
- Acronym
- TBAD
- Status last verified
- Nov 2011
- First submitted
- 4 Nov 2011
- Last updated
- 16 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventions to Promote Adherence to Tuberculosis Treatment Among Patients Attending Basic Medical Unit of Taluka Gambat, Pakistan
- ClinicalTrials.gov ID
- NCT01471977
- Acronym / sponsor ID
- TBAD / TB
- Conditions
- Tuberculosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,280 participants (actual)
- Lead sponsor
- Gambat Institute of Medical SciencesIndustry (pharma, biotech, devices)
- Study start
- Jan 2004
- Primary completion
- Dec 2007 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 16 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| education, counselling, default tracer | Experimental | Other: education,counseling, default tracers,quality of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- adult patient
- > 18years
- either sex
- diagnosed to have tuberculosis through chest x ray or sputum microscopy
- eligible to participate in the study
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| education,counseling, default tracers,quality of careAlso: tuberculosis, directly observed short course treatment, education and counseling, default tracerthese interventions were administered along with standard treatment i.e. DOTS at the time of standard follow up of patients at clinic | Other | education, counselling, default tracer |
Primary outcome
Proportion of patients cured
Time frame: 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
Time frame: 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
Time frame: 8 months
died during the course of treatment
proportion of patients defaulted
Time frame: 8 months
not collected drugs for more than 2 consecutive months either sputum smear positive or negative
proportion of patients with treatment failure
Time frame: 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
Time frame: 8 months
Transferred to another TB register
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nisar Sheikh, MBBS principal investigator
GIMS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing education,counseling, default tracers,quality of care in people with Tuberculosis, run by Gambat Institute of Medical Sciences at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients cured (time frame: 8 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2011.