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Simple Verbal Intervention for Adequately Collecting Sputum

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ClinicalTrials.gov Identifier: NCT01135043
Recruitment Status : Unknown
Verified May 2010 by Seoul National University Hospital.
Recruitment status was:  Recruiting
First Posted : June 2, 2010
Last Update Posted : June 2, 2010
Sponsor:
Information provided by:
Seoul National University Hospital

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.


Condition or disease Intervention/treatment Phase
Suspicious for Pulmonary Tuberculosis Behavioral: education by brochure Behavioral: control Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 188 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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 Start Date : July 2009
Estimated Primary Completion Date : June 2010
Estimated Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis

Arm Intervention/treatment
Experimental: education
educated with the brochure that contains figure of lung/upper respiratory tract and methods of collecting sputum.
Behavioral: education by brochure
educated with the brochure that contains figure of lung/upper respiratory tract and methods of collecting sputum.

Placebo Comparator: control
patients with control group are educated about methods of collecting sputum by a physician, only in verbal explanation without brochure.
Behavioral: control
patients with control group are educated about methods of collecting sputum by a physician, only in verbal explanation without brochure




Primary Outcome Measures :
  1. culture result of Mycobacteria in sputum [ Time Frame: 8wk after AFB culture ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01135043


Contacts
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Contact: Chang-Hoon Lee, MD +82- 2- 870- 2232 kauri670@gmail.com
Contact: Yeon-Joo Lee, MD +82-10-9044-3987 yeonjoolee1117@gmail.com

Locations
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Korea, Republic of
Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul Metropolitan Government, Seoul National University Boramae Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Chang-Hoon Lee, MD    +82- 2- 870- 2232    kauri670@gmail.com   
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Chang-Hoon Lee, Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul Metropolitan Government, Seoul National University Boramae Medical Center
ClinicalTrials.gov Identifier: NCT01135043     History of Changes
Other Study ID Numbers: acceptable_sputa
First Posted: June 2, 2010    Key Record Dates
Last Update Posted: June 2, 2010
Last Verified: May 2010

Keywords provided by Seoul National University Hospital:
acceptable sputum
AFB culture
pulmonary tuberculosis

Additional relevant MeSH terms:
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Tuberculosis
Tuberculosis, Pulmonary
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections