Korean Linguistic Adaptation of Rhinitis Controlled Assessment Test (R-CAT)

April 28, 2016 updated by: Hae-Sim Park, Ajou University School of Medicine

Linguistic Adaptation of Rhinitis Control Assessment Test (RCAT) in Korean and Responsiveness to Disease Severity, Quality of Life, and Treatment in Adult Rhinitis Patients: A Multicenter Prospective Study

Korean linguistic adaptation of Rhinitis controlled assessment test (RCAT).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Check the Korean version of rhinitis controlled assessment tests, the total non-symptom scores (total nasal symptoms score, TNSS), rhinitis-related quality of life (RQLQ), rhinitis controlled degree, severity, and after study enrollment and 4 weeks treatment.

Study Type

Observational

Enrollment (Actual)

130

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

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

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

rhinitis within 12 months from the time of study enrollment.

Description

Inclusion Criteria:

  1. Adults over 19 years
  2. Past medical history and allergy skin test or who have been diagnosed with allergic or non-allergic rhinitis, based on serum specific immunoglobulin E .
  3. People who have experienced symptoms of rhinitis within 12 months from the time of study enrollment.
  4. People who have rhinitis symptoms requiring medication at the time of study enrollment.
  5. People who can read and write korea language.
  6. People who signed a written consent form approved by the Institutional Review Board of their respective organizations to participate in this study freely hearing to explain fully the purpose for the contents of this study prior to participation in research.

Exclusion Criteria:

  1. People diagnosed with Rhinitis medicamentosa.
  2. People determined that bacterial or viral respiratory infection at the time of study enrollment.
  3. People who have evidence of nasal infection
  4. People associated anatomical abnormality that causes severe nasal congestion as deviation of nasal septum.
  5. People determined that acute or chronic sinusitis according to the researchers determined.
  6. In case that pregnancy test is positive, or ambiguous conclusions among female patients.
  7. people deemed unsuitable for clinical trial participation due to other reasons.

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Korean linguistic adaptation of Rhinitis controlled assessment test (RCAT)
Time Frame: up to 4weeks
Check the Korean version of rhinitis controlled assessment tests
up to 4weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
rhinitis-related quality of life
Time Frame: up to 4weeks
rhinitis-related quality of life (RQLQ)check up to 24 weeks
up to 4weeks

Collaborators and Investigators

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

Investigators

  • Principal Investigator: hae sim park, professor, Department of Internal Medicine

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

October 1, 2014

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

October 17, 2014

First Submitted That Met QC Criteria

October 29, 2014

First Posted (Estimate)

October 31, 2014

Study Record Updates

Last Update Posted (Estimate)

May 2, 2016

Last Update Submitted That Met QC Criteria

April 28, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • MED-OBS-14-158

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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