Simple Verbal Intervention for Adequately Collecting Sputum

May 28, 2010 updated by: Seoul National University Hospital

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

188

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Recruiting
        • Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul Metropolitan Government, Seoul National University Boramae Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
culture result of Mycobacteria in sputum
Time Frame: 8wk after AFB culture
8wk after AFB culture

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • 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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Anticipated)

June 1, 2010

Study Completion (Anticipated)

September 1, 2010

Study Registration Dates

First Submitted

May 28, 2010

First Submitted That Met QC Criteria

May 28, 2010

First Posted (Estimate)

June 2, 2010

Study Record Updates

Last Update Posted (Estimate)

June 2, 2010

Last Update Submitted That Met QC Criteria

May 28, 2010

Last Verified

May 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • acceptable_sputa

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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