Scleroderma, SystemicNCT03219606
Impact of Education and Training of Modified Rodnan Skin Scoring on the Reliability of Test
A study testing Organized education course of Modified Rodnan Skin Scoring in people with Scleroderma, Systemic, run by Seoul National University Hospital at 1 site in South Korea.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Scleroderma, Systemic
- What is being tested?
- Organized education course of Modified Rodnan Skin Scoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSouth Korea
- Study dates
- 19 Jun 2017to 30 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Physician who voluntarily enroll the educational program.
Who cannot join
- Non-physician
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, 110-744
Eun Bong Lee, MD PhD, 82-2-2072-3944, leb7616@snu.ac.kr
Jun Won Park, MD, 82-2-2072-3198, mpersonality@gmail.com
About this study
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.
Read the detailed description
- Participants Ten physicians who are voluntarily enrolled in the organized education course
- 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
- 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.
- 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.
- Conditions
- Scleroderma, Systemic
- Being tested
- Organized education course of Modified Rodnan Skin Scoring
- Keywords
- Systemic sclerosis, Education, Modified Rodnan skin score
- Medical subject headings
- Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Organized education course of Modified Rodnan Skin ScoringOther
- 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.
| Study group | Role | What they receive |
|---|---|---|
| education arm | Experimental | Participants in education arm will have an organized education course of modified Rodnan Skin Scoring. Receives: Other: Organized education course of Modified Rodnan Skin Scoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in difference between score measured by each participant and standard score after the organized education course.
Measured: 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
Measured: 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
Measured: 1. One day before the education course 2. After 20 minutes of the lecture 3. After 20 minutes of the demonstration and practical training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2017
- Study start19 Jun 2017
- Primary completion31 Oct 2017 (estimated)
- Study completion30 Jun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Scleroderma, SystemicStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eun Bong Lee, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03219606
- Sponsor's protocol ID
- 1715-133-856
- Status last verified
- Jul 2017
- First submitted
- 28 Jun 2017
- Last updated
- 17 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 28516167Czirjak 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.
PubMed 17234649
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Education and Training of Modified Rodnan Skin Scoring on the Reliability of Test
- ClinicalTrials.gov ID
- NCT03219606
- Acronym / sponsor ID
- 1715-133-856
- Conditions
- Scleroderma, Systemic
- Keywords
- Systemic sclerosis, Education, Modified Rodnan skin score
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 19 Jun 2017 (actual)
- Primary completion
- 31 Oct 2017 (estimated)
- Study completion
- 30 Jun 2018 (estimated)
- First posted
- 17 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Participants Ten physicians who are voluntarily enrolled in the organized education course
- 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
- 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.
- 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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| education arm | Experimental | Other: Organized education course of Modified Rodnan Skin ScoringParticipants in education arm will have an organized education course of modified Rodnan Skin Scoring. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Physician who voluntarily enroll the educational program.
Key exclusion criteria (1 listed)
- Non-physician
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Organized education course of Modified Rodnan Skin Scoring1. 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. | Other | education arm |
Primary outcome
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
2 secondary outcomes
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2017.
- Background: PubMed 28516167Khanna 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 publication: PubMed 17234649Czirjak 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Organized education course of Modified Rodnan Skin Scoring in people with Scleroderma, Systemic, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eun Bong Lee, MD PhD (82-2-2072-3944, leb7616@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03219606, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2017.