Back to resultsSimple Verbal Intervention for Adequately Collecting Sputum
Primary Purpose
Suspicious for Pulmonary Tuberculosis
Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
education by brochure
control
Sponsored by
About this trial
This is an interventional diagnostic trial for Suspicious for Pulmonary Tuberculosis focused on measuring acceptable sputum, AFB culture, pulmonary tuberculosis
Eligibility Criteria
Inclusion Criteria:
- age > 18 years
- 2009.7~2010.7 patients with suspicious pulmonary tuberculosis who visited Boramae Hospital
Exclusion Criteria:
- 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
Sites / Locations
- Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul Metropolitan Government, Seoul National University Boramae Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
education
control
Arm Description
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.
Outcomes
Primary Outcome Measures
culture result of Mycobacteria in sputum
Secondary Outcome Measures
Full Information
NCT ID
NCT01135043
First Posted
May 28, 2010
Last Updated
May 28, 2010
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01135043
Brief Title
Simple Verbal Intervention for Adequately Collecting Sputum
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2010
Overall Recruitment Status
Unknown status
Study Start Date
July 2009 (undefined)
Primary Completion Date
June 2010 (Anticipated)
Study Completion Date
September 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Seoul National University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suspicious for Pulmonary Tuberculosis
Keywords
acceptable sputum, AFB culture, pulmonary tuberculosis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
188 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
education
Arm Type
Experimental
Arm Description
educated with the brochure that contains figure of lung/upper respiratory tract and methods of collecting sputum.
Arm Title
control
Arm Type
Placebo Comparator
Arm Description
patients with control group are educated about methods of collecting sputum by a physician, only in verbal explanation without brochure.
Intervention Type
Behavioral
Intervention Name(s)
education by brochure
Intervention Description
educated with the brochure that contains figure of lung/upper respiratory tract and methods of collecting sputum.
Intervention Type
Behavioral
Intervention Name(s)
control
Intervention Description
patients with control group are educated about methods of collecting sputum by a physician, only in verbal explanation without brochure
Primary Outcome Measure Information:
Title
culture result of Mycobacteria in sputum
Time Frame
8wk after AFB culture
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age > 18 years
2009.7~2010.7 patients with suspicious pulmonary tuberculosis who visited Boramae Hospital
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chang-Hoon Lee, MD
Phone
+82- 2- 870- 2232
Email
kauri670@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yeon-Joo Lee, MD
Phone
+82-10-9044-3987
Email
yeonjoolee1117@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chang-Hoon Lee, MD
Organizational Affiliation
Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul Metropolitan Government, Seoul National University Boramae Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul Metropolitan Government, Seoul National University Boramae Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chang-Hoon Lee, MD
Phone
+82- 2- 870- 2232
Email
kauri670@gmail.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
24200273
Citation
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.
Results Reference
derived
Learn more about this trial
Simple Verbal Intervention for Adequately Collecting Sputum
We'll reach out to this number within 24 hrs