Impact of Education and Training of Modified Rodnan Skin Scoring on the Reliability of Test

July 13, 2017 updated by: Eun Bong Lee, Seoul National University Hospital
The aim of the study is evaluating the efficacy of organized education process of the modified Rodnan Skin Score (MRSS) in the systemic sclerosis. Ten physician in South Korea will be voluntarily enrolled and receive the organized training program, which encompass the lecture and demonstration of skin scoring by expert rheumatologist. Reliability and accuracy of the skin scoring before and after the education will be compared.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

1. Participants Ten physicians who are voluntarily enrolled in the organized education course

2. Organized education course

  1. Lecture: A expert rheumatologist (master instructor) give a lecture to explain the technique of MRSS.
  2. Demonstration: Master instructor demonstrate the patient assessment without revealing his score.
  3. Practical training: Participants assess the MRSS of 8 patients with systemic sclerosis. Two other expert rheumatologists

3. Protocol

  1. Instructor pre-meeting: Three instructors including master instructor assess the MRSS of 8 systemic sclerosis patients. Modified Rodnan score drawn by arrangement among them is defined as standard score of each patient.
  2. Pre-education scoring: Participants assess the MRSS of 8 patients before the education course.
  3. Organized education course
  4. Post-education scoring: Participants assess the MRSS of the same 8 patients after i) lecture and ii) demonstration of master instructor
  5. written test: Participants take written examination regarding the MRSS before and after the education.

4. Outcomes

  1. Inter-observer reliability of MRSS before and after the education
  2. Change in difference between score measure by each participant and standard score after the educational course.
  3. Change in the score of written test after the educational course.

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Not Applicable

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, 110-744
        • Recruiting
        • Seoul National University Hospital
        • Contact:
        • Sub-Investigator:
          • Jun Won Park, MD

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Physician who voluntarily enroll the educational program.

Exclusion Criteria:

  • Non-physician

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: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: education arm
Participants in education arm will have an organized education course of modified Rodnan Skin Scoring.
Other: Organized education course of Modified Rodnan Skin Scoring
  1. Lecture: An expert rheumatologist (master instructor) give a lecture to explain the technique of Modified Rodnan Skin Scoring (MRSS).
  2. Demonstration: Master instructor demonstrate the patient assessment without revealing his score.
  3. Practical training: Participants assess the MRSS of 8 patients with systemic sclerosis. Two other expert rheumatologists assist the course.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in difference between score measured by each participant and standard score after the organized education course.
Time Frame: 1. One day before the education course 2. After 20 minutes of the lecture 3. After 20 minutes of the demonstration and practical training
1. One day before the education course 2. After 20 minutes of the lecture 3. After 20 minutes of the demonstration and practical training

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in written test score of each participant after the organized education course
Time Frame: 1. One day before the education course 2. After 20 minutes of the lecture 3. After 20 minutes of the demonstration and practical training
1. One day before the education course 2. After 20 minutes of the lecture 3. After 20 minutes of the demonstration and practical training
Change in inter-observer reliability of MRSS after the organized education course
Time Frame: 1. One day before the education course 2. After 20 minutes of the lecture 3. After 20 minutes of the demonstration and practical training
1. One day before the education course 2. After 20 minutes of the lecture 3. After 20 minutes of the demonstration and practical training

Collaborators and Investigators

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

Sponsor

Seoul National University Hospital

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 (Actual)

June 19, 2017

Primary Completion (Anticipated)

October 31, 2017

Study Completion (Anticipated)

June 30, 2018

Study Registration Dates

First Submitted

June 28, 2017

First Submitted That Met QC Criteria

July 13, 2017

First Posted (Actual)

July 17, 2017

Study Record Updates

Last Update Posted (Actual)

July 17, 2017

Last Update Submitted That Met QC Criteria

July 13, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1715-133-856

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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