Suspicious for Pulmonary TuberculosisPhase 4NCT01135043
Simple Verbal Intervention for Adequately Collecting Sputum
A Phase 4 study testing education by brochure in people with Suspicious for Pulmonary Tuberculosis, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
simple verbal intervention with figure of lung and upper respiratory tract will be helpful to adequately collecting sputum. and in the acceptable specimen based on Gram stain, positivity for AFB stain and culture rate will be higher. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Suspicious for Pulmonary Tuberculosis
- What is being tested?
- education by brochure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 188 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2009to Sep 2010
- Phase
- Phase 4
- 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
- age > 18 years
- 2009.7~2010.7 patients with suspicious pulmonary tuberculosis who visited Boramae Hospital
Who cannot join
- on medication for tuberculosis
- patients who medicated with fluoroquinolone within 1month
- patients without consciousness or patients who cannot expectorate sputum
- hemoptysis over 50cc per day
- patients who don't consent on the study
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul Metropolitan Government, Seoul National University Boramae Medical Center
Seoul
Chang-Hoon Lee, MD, +82- 2- 870- 2232, kauri670@gmail.com
About this study
Official title: The Impact of the Simple Verbal Intervention for Adequately Collecting Sputum and the Acceptable Specimen Based on Gram Stain, on the Results of Sputum Acid-fast Bacilli Smear Testing
simple verbal intervention with figure of lung and upper respiratory tract will be helpful to adequately collecting sputum.
and in the acceptable specimen based on Gram stain, positivity for AFB stain and culture rate will be higher.
Read the detailed description
suspicious patients for pulmonary tuberculosis are randomized to control or education group. patients in education group will be educated with the brochure that contains figure of lung/upper respiratory tract and methods of collecting sputum.
- Conditions
- Suspicious for Pulmonary Tuberculosis
- Being tested
- education by brochure, control
- Keywords
- acceptable sputum, AFB culture, pulmonary tuberculosis
- Medical subject headings
- Tuberculosis, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
education by brochureBehavioural
educated with the brochure that contains figure of lung/upper respiratory tract and methods of collecting sputum.
controlBehavioural
patients with control group are educated about methods of collecting sputum by a physician, only in verbal explanation without brochure
| Study group | Role | What they receive |
|---|---|---|
| education | Experimental | educated with the brochure that contains figure of lung/upper respiratory tract and methods of collecting sputum. Receives: Behavioral: education by brochure |
| control | Placebo comparator | patients with control group are educated about methods of collecting sputum by a physician, only in verbal explanation without brochure. Receives: Behavioral: control |
What is being measured
The primary outcome is the main question the study is designed to answer.
culture result of Mycobacteria in sputum
Measured: 8wk after AFB culture
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2010 (estimated)
- Study startJul 2009
- Primary completionJun 2010 (estimated)
- Study completionSep 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Suspicious for Pulmonary TuberculosisStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 188 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Chang-Hoon Lee, MD, Study chair, Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul Metropolitan Government, Seoul National University Boramae Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01135043
- Sponsor's protocol ID
- acceptable_sputa
- Status last verified
- May 2010
- First submitted
- 28 May 2010
- Last updated
- 2 Jun 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lee YJ, Shin S, Roh EY, Yoon JH, Kim DK, Chung HS, Lee CH. The effectiveness of a brochure describing an acceptable method of sputum collection for tuberculosis testing. Int J Tuberc Lung Dis. 2013 Dec;17(12):1587-9. doi: 10.5588/ijtld.13.0336.
PubMed 24200273
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of the Simple Verbal Intervention for Adequately Collecting Sputum and the Acceptable Specimen Based on Gram Stain, on the Results of Sputum Acid-fast Bacilli Smear Testing
- ClinicalTrials.gov ID
- NCT01135043
- Acronym / sponsor ID
- acceptable_sputa
- Conditions
- Suspicious for Pulmonary Tuberculosis
- Keywords
- acceptable sputum, AFB culture, pulmonary tuberculosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 188 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Jun 2010 (estimated)
- Study completion
- Sep 2010 (estimated)
- First posted
- 2 Jun 2010 (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.
simple verbal intervention with figure of lung and upper respiratory tract will be helpful to adequately collecting sputum.
and in the acceptable specimen based on Gram stain, positivity for AFB stain and culture rate will be higher.
Detailed description
suspicious patients for pulmonary tuberculosis are randomized to control or education group. patients in education group will be educated with the brochure that contains figure of lung/upper respiratory tract and methods of collecting sputum.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| education | Experimental | Behavioral: education by brochureeducated with the brochure that contains figure of lung/upper respiratory tract and methods of collecting sputum. |
| control | Placebo comparator | Behavioral: controlpatients with control group are educated about methods of collecting sputum by a physician, only in verbal explanation without brochure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age > 18 years
- 2009.7~2010.7 patients with suspicious pulmonary tuberculosis who visited Boramae Hospital
Key exclusion criteria (5 listed)
- on medication for tuberculosis
- patients who medicated with fluoroquinolone within 1month
- patients without consciousness or patients who cannot expectorate sputum
- hemoptysis over 50cc per day
- patients who don't consent on the study
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 by brochureeducated with the brochure that contains figure of lung/upper respiratory tract and methods of collecting sputum. | Behavioural | education |
| controlpatients with control group are educated about methods of collecting sputum by a physician, only in verbal explanation without brochure | Behavioural | control |
Primary outcome
culture result of Mycobacteria in sputum
Time frame: 8wk after AFB culture
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2010.
- Derived from this study: PubMed 24200273Lee YJ, Shin S, Roh EY, Yoon JH, Kim DK, Chung HS, Lee CH. The effectiveness of a brochure describing an acceptable method of sputum collection for tuberculosis testing. Int J Tuberc Lung Dis. 2013 Dec;17(12):1587-9. doi: 10.5588/ijtld.13.0336.
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.
Chang-Hoon Lee, MD study chair
Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul Metropolitan Government, Seoul National University Boramae Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing education by brochure in people with Suspicious for Pulmonary Tuberculosis, run by Seoul National University Hospital at 1 site in South Korea.
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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 2 Jun 2010. 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 South Korea. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chang-Hoon Lee, MD (+82- 2- 870- 2232, kauri670@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
culture result of Mycobacteria in sputum (time frame: 8wk after AFB culture). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01135043, which also lists 1 linked publication.
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 2 Jun 2010.