Simple Verbal Intervention for Adequately Collecting Sputum

Suspicious for Pulmonary Tuberculosis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01135043
• Other study ID #: acceptable_sputa
• Status: Recruiting
• Phase: Phase 4
• First received: May 28, 2010
• Last updated: May 28, 2010
• Start date: July 2009
• Est. completion date: September 2010

Study information

• Verified date: May 2010
• Source: Seoul National University Hospital
• Contact: Chang-Hoon Lee, MD
• Phone: +82- 2- 870- 2232
• Email: kauri670[@]gmail.com
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 188
• Est. completion date: September 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Suspicious for Pulmonary Tuberculosis
• Tuberculosis
• Tuberculosis, Pulmonary

Intervention

Behavioral:
• education by brochure
educated with the brochure that contains figure of lung/upper respiratory tract and methods of collecting sputum.
• control
patients with control group are educated about methods of collecting sputum by a physician, only in verbal explanation without brochure

Locations

Country	Name	City	State
Korea, Republic of	Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul Metropolitan Government, Seoul National University Boramae Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	culture result of Mycobacteria in sputum		8wk after AFB culture	No