Ignite Creation Date:
2025-12-26 @ 2:42 PM
Ignite Modification Date:
2026-01-04 @ 3:43 AM
Study NCT ID:
NCT03219606
Status:
UNKNOWN
Last Update Posted:
2017-07-17
First Post:
2017-06-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Education and Training of Modified Rodnan Skin Scoring on the Reliability of Test
Sponsor:
Seoul National University Hospital
Organization:
Study Overview
Official Title:
Impact of Education and Training of Modified Rodnan Skin Scoring on the Reliability of Test
Status:
UNKNOWN
Status Verified Date:
2017-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: