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NCT03219606 Clinical Trial

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

Scleroderma, Systemic Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03219606
Other study ID # 1715-133-856
Secondary ID
Status Recruiting
Phase N/A
First received June 28, 2017
Last updated July 13, 2017
Start date June 19, 2017
Est. completion date June 30, 2018

Study information
Verified date July 2017
Source Seoul National University Hospital
Contact Eun Bong Lee, MD PhD
Phone 82-2-2072-3944
Email leb7616@snu.ac.kr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 10
Est. completion date June 30, 2018
Est. primary completion date October 31, 2017
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- Physician who voluntarily enroll the educational program.

Exclusion Criteria:

- Non-physician

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Organized education course of Modified Rodnan Skin Scoring
Lecture: An expert rheumatologist (master instructor) give a lecture to explain the technique of Modified Rodnan Skin Scoring (MRSS). Demonstration: Master instructor demonstrate the patient assessment without revealing his score. Practical training: Participants assess the MRSS of 8 patients with systemic sclerosis. Two other expert rheumatologists assist the course.

Locations
Country Name City State
Korea, Republic of Seoul National University Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (2)

Czirják L, Nagy Z, Aringer M, Riemekasten G, Matucci-Cerinic M, Furst DE; EUSTAR. The EUSTAR model for teaching and implementing the modified Rodnan skin score in systemic sclerosis. Ann Rheum Dis. 2007 Jul;66(7):966-9. Epub 2007 Jan 18. — View Citation

Khanna D, Furst DE, Clements PJ, Allanore Y, Baron M, Czirjak L, Distler O, Foeldvari I, Kuwana M, Matucci-Cerinic M, Mayes M, Medsger T Jr, Merkel PA, Pope JE, Seibold JR, Steen V, Stevens W, Denton CP. Standardization of the modified Rodnan skin score for use in clinical trials of systemic sclerosis. J Scleroderma Relat Disord. 2017 Jan-Apr;2(1):11-18. doi: 10.5301/jsrd.5000231. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Change in difference between score measured by each participant and standard score after the organized education course. 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 Change in written test score of each participant after the organized education course 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 Change in inter-observer reliability of MRSS after the organized education course 1. One day before the education course 2. After 20 minutes of the lecture 3. After 20 minutes of the demonstration and practical training
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