NCT03219606

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 19, 2017

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

June 28, 2017

Completed
19 days until next milestone

First Posted

Study publicly available on registry

July 17, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2017

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed
Last Updated

July 17, 2017

Status Verified

July 1, 2017

Enrollment Period

4 months

First QC Date

June 28, 2017

Last Update Submit

July 13, 2017

Conditions

Scleroderma, Systemic

Keywords

Systemic sclerosisEducationModified Rodnan skin score

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • 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

  • 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

Study Arms (1)

education arm

EXPERIMENTAL

Participants in education arm will have an organized education course of modified Rodnan Skin Scoring.

Other: Organized education course of Modified Rodnan Skin Scoring

Interventions

Organized education course of Modified Rodnan Skin ScoringOTHER

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.

education arm

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Physician who voluntarily enroll the educational program.

You may not qualify if:

  • Non-physician

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

RECRUITING

Related Publications (2)

  • 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.

    PMID: 28516167BACKGROUND

  • 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.

    PMID: 17234649RESULT

MeSH Terms

Conditions

Scleroderma, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesSkin Diseases

Central Study Contacts

Eun Bong Lee, MD PhD

CONTACT

82-2-2072-3944leb7616@snu.ac.kr

Jun Won Park, MD

CONTACT

82-2-2072-3198mpersonality@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 28, 2017

First Posted

July 17, 2017

Study Start

June 19, 2017

Primary Completion

October 31, 2017

Study Completion

June 30, 2018

Last Updated

July 17, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will share

Locations

KR(1)