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

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ClinicalTrials.gov Identifier: NCT03219606
Recruitment Status : Recruiting
First Posted : July 17, 2017
Last Update Posted : July 17, 2017
Sponsor:
Information provided by (Responsible Party):
Eun Bong Lee, Seoul National University Hospital

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.

Condition or disease Intervention/treatment Phase
Scleroderma, Systemic Other: Organized education course of Modified Rodnan Skin Scoring Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Impact of Education and Training of Modified Rodnan Skin Scoring on the Reliability of Test
Actual Study Start Date : June 19, 2017
Estimated Primary Completion Date : October 31, 2017
Estimated Study Completion Date : June 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scleroderma

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.




Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]
  2. 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 ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Physician who voluntarily enroll the educational program.

Exclusion Criteria:

  • Non-physician

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03219606


Contacts
Contact: Eun Bong Lee, MD PhD 82-2-2072-3944 leb7616@snu.ac.kr
Contact: Jun Won Park, MD 82-2-2072-3198 mpersonality@gmail.com

Locations
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Contact: Eun Bong Lee, MD PhD    82-2-2072-3944    leb7616@snu.ac.kr   
Contact: Jun Won Park, MD    82-2-2072-3198    mpersonality@gmail.com   
Principal Investigator: Eun Bong Lee, MD PhD         
Sub-Investigator: Jun Won Park, MD         
Sponsors and Collaborators
Seoul National University Hospital

Publications of Results:
Other Publications:
Responsible Party: Eun Bong Lee, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03219606     History of Changes
Other Study ID Numbers: 1715-133-856
First Posted: July 17, 2017    Key Record Dates
Last Update Posted: July 17, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Eun Bong Lee, Seoul National University Hospital:
Systemic sclerosis
Education
Modified Rodnan skin score

Additional relevant MeSH terms:
Scleroderma, Systemic
Scleroderma, Diffuse
Connective Tissue Diseases
Skin Diseases