Impact of Education and Training of Modified Rodnan Skin Scoring on the Reliability of Test
Primary Purpose
Scleroderma, Systemic
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Organized education course of Modified Rodnan Skin Scoring
Sponsored by
About this trial
This is an interventional other trial for Scleroderma, Systemic focused on measuring Systemic sclerosis, Education, Modified Rodnan skin score
Eligibility Criteria
Inclusion Criteria:
- Physician who voluntarily enroll the educational program.
Exclusion Criteria:
- Non-physician
Sites / Locations
- Seoul National University HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
education arm
Arm Description
Participants in education arm will have an organized education course of modified Rodnan Skin Scoring.
Outcomes
Primary Outcome Measures
Change in difference between score measured by each participant and standard score after the organized education course.
Secondary Outcome Measures
Change in written test score of each participant after the organized education course
Change in inter-observer reliability of MRSS after the organized education course
Full Information
NCT ID
NCT03219606
First Posted
June 28, 2017
Last Updated
July 13, 2017
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03219606
Brief Title
Impact of Education and Training of Modified Rodnan Skin Scoring on the Reliability of Test
Official Title
Impact of Education and Training of Modified Rodnan Skin Scoring on the Reliability of Test
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Unknown status
Study Start Date
June 19, 2017 (Actual)
Primary Completion Date
October 31, 2017 (Anticipated)
Study Completion Date
June 30, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
Lecture: A expert rheumatologist (master instructor) give a lecture to explain the technique of 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
3. Protocol
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.
Pre-education scoring: Participants assess the MRSS of 8 patients before the education course.
Organized education course
Post-education scoring: Participants assess the MRSS of the same 8 patients after i) lecture and ii) demonstration of master instructor
written test: Participants take written examination regarding the MRSS before and after the education.
4. Outcomes
Inter-observer reliability of MRSS before and after the education
Change in difference between score measure by each participant and standard score after the educational course.
Change in the score of written test after the educational course.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scleroderma, Systemic
Keywords
Systemic sclerosis, Education, Modified Rodnan skin score
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
education arm
Arm Type
Experimental
Arm Description
Participants in education arm will have an organized education course of modified Rodnan Skin Scoring.
Intervention Type
Other
Intervention Name(s)
Organized education course of Modified Rodnan Skin Scoring
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
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
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Physician who voluntarily enroll the educational program.
Exclusion Criteria:
Non-physician
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eun Bong Lee, MD PhD
Phone
82-2-2072-3944
Email
leb7616@snu.ac.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Jun Won Park, MD
Phone
82-2-2072-3198
Email
mpersonality@gmail.com
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eun Bong Lee, MD PhD
Phone
82-2-2072-3944
Email
leb7616@snu.ac.kr
First Name & Middle Initial & Last Name & Degree
Jun Won Park, MD
Phone
82-2-2072-3198
Email
mpersonality@gmail.com
First Name & Middle Initial & Last Name & Degree
Eun Bong Lee, MD PhD
First Name & Middle Initial & Last Name & Degree
Jun Won Park, MD
12. IPD Sharing Statement
Plan to Share IPD
Yes
Citations:
PubMed Identifier
28516167
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.
Results Reference
background
PubMed Identifier
17234649
Citation
Czirjak 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. doi: 10.1136/ard.2006.066530. Epub 2007 Jan 18.
Results Reference
result
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Impact of Education and Training of Modified Rodnan Skin Scoring on the Reliability of Test
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