Simple Verbal Intervention for Adequately Collecting Sputum
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
1 other identifier
interventional
188
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jul 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2009
CompletedFirst Submitted
Initial submission to the registry
May 28, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedFirst Posted
Study publicly available on registry
June 2, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2010
CompletedJune 2, 2010
May 1, 2010
11 months
May 28, 2010
May 28, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
culture result of Mycobacteria in sputum
8wk after AFB culture
Study Arms (2)
education
EXPERIMENTALeducated with the brochure that contains figure of lung/upper respiratory tract and methods of collecting sputum.
control
PLACEBO COMPARATORpatients with control group are educated about methods of collecting sputum by a physician, only in verbal explanation without brochure.
Interventions
educated with the brochure that contains figure of lung/upper respiratory tract and methods of collecting sputum.
patients with control group are educated about methods of collecting sputum by a physician, only in verbal explanation without brochure
Eligibility Criteria
You may qualify if:
- age \> 18 years
- \~2010.7 patients with suspicious pulmonary tuberculosis who visited Boramae Hospital
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul Metropolitan Government, Seoul National University Boramae Medical Center
Seoul, South Korea
Related Publications (1)
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.
PMID: 24200273DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Chang-Hoon Lee, MD
Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul Metropolitan Government, Seoul National University Boramae Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 28, 2010
First Posted
June 2, 2010
Study Start
July 1, 2009
Primary Completion
June 1, 2010
Study Completion
September 1, 2010
Last Updated
June 2, 2010
Record last verified: 2010-05