| Registry | NCT01629784 |
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| Status | Completed |
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| Phase | Not applicable |
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| Study type | Interventional; na, single group, masking: none |
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| Enrollment | 31 (Actual) |
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| Sponsor | Northwestern University (Other) |
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| Conditions | Cutaneous Lupus Erythematosus |
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| Interventions | Cutaneous Lupus educational script (Behavioral) |
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| Dates | start 2012-05-01, primary completion 2013-01-01, completion 2013-01-01, first posted 2012-06-28, last updated 2013-06-03 |
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| Locations | 1 site in United States |
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-Summary
Studies have shown that there are significant differences in severity and outcome of lupus in patients of colored skin compared with Caucasians. There are many factors that lead to this discrepancy: genetics, poverty, education level, as well as behavioral and cultural factors. Cutaneous Lupus Erythematosus (CLE) is a disease of flares and remissions with identifiable triggers. One of the most aggravating triggers in CLE is sun exposure. The investigators hypothesize that there are disparities in knowledge about photoprotection, leading to poorer outcomes in minority ethnic groups. This study aims to assess knowledge of risk factors and triggers, especially sun exposure, and the effects on quality of life of Caucasian and minority populations, by conducting an assessment survey and subsequent teaching intervention on appropriate skin protection techniques including appropriate sun screen application, and use of sun-protective clothing. After three months a survey to evaluate knowledge retention about and the application of the educational intervention will be conducted.
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+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| CLE and sun counseling | Other | Behavioral: Cutaneous Lupus educational script | |
- Cutaneous Lupus educational script (Behavioral): Subjects will listen to a short informational script on Cutaneous lupus and skin protection
+Outcome measures
Primary outcomes
- Percentage of Subjects Who Correctly Answered a Knowledge Assessment Item Immediately Before and After an Educational Lecture [immediately before and after an educational lecture]: In order to evaluate the immediate effect of an educational lecture about cutaneous lupus erythematosus (CLE) and sun protection, subjects completed a written questionnaire to assess knowledge about CLE and sun protection immediately before and after the educational lecture. The percentage of subjects who correctly answered a knowledge assessment item were calculated pre- and post-educational lecture.
Secondary outcomes
- Percentage of Subjects Who Correctly Answered a Knowledge or Behavioral Assessment Item Before and 3 Months After an Educational Lecture [before and 3 months after an educational lecture]: In order to evaluate the long-term effect of an educational lecture about cutaneous lupus erythematosus (CLE) and sun protection, subjects completed a questionnaire to assess knowledge about CLE and sun protection behaviors immediately before and three months after an educational lecture. The percentage of subjects who correctly answered a knowledge or behavioral assessment item were calculated pre- and three months post-educational lecture.
+Eligibility
Sex: All, ages: 18 Years to any
Inclusion Criteria:
* Subjects with a diagnosis of cutaneous lupus erythematous
* Subjects ages 18 years of age and older and able to give consent
Exclusion Criteria:
* That which does not fit the inclusion criteria
+Posted results
Participant flow
| Milestone | Cutaneous Lupus Erythematosus (CLE) |
|---|
| Started | 31 |
| Completed | 25 |
| Not completed | 6 |
Outcome results
- Percentage of Subjects Who Correctly Answered a Knowledge Assessment Item Immediately Before and After an Educational Lecture (Primary), Number, percentage of participants: Pre-educational Lecture 52; Post-educational Lecture 94
- Percentage of Subjects Who Correctly Answered a Knowledge or Behavioral Assessment Item Before and 3 Months After an Educational Lecture (Secondary), Number, percentage of participants: Pre-educational Lecture 19; Three Months Post-educational Lecture 45
Adverse events
| Arm | Deaths | Serious adverse events | Other adverse events |
|---|
| Cutaneous Lupus Erythematosus (CLE) | 0 | 0/31 (0.0%) | 0/31 (0.0%) |
+Locations (1)
| Facility | City | Country | Status |
|---|
| Northwestern University Department of Dermatology | Chicago, Illinois | United States | |
+Publications
- Finlay AY. Quality of life assessments in dermatology. Semin Cutan Med Surg. 1998 Dec;17(4):291-6. doi: 10.1016/s1085-5629(98)80026-6. PMID 9859917
- Foering K, Goreshi R, Klein R, Okawa J, Rose M, Cucchiara A, Werth VP. Prevalence of self-report photosensitivity in cutaneous lupus erythematosus. J Am Acad Dermatol. 2012 Feb;66(2):220-8. doi: 10.1016/j.jaad.2010.12.006. Epub 2011 Jul 13. PMID 21742409
- Kundu RV, Kamaria M, Ortiz S, West DP, Rademaker AW, Robinson JK. Effectiveness of a knowledge-based intervention for melanoma among those with ethnic skin. J Am Acad Dermatol. 2010 May;62(5):777-84. doi: 10.1016/j.jaad.2009.08.047. Epub 2010 Mar 9. PMID 20219266
- Werth VP. Clinical manifestations of cutaneous lupus erythematosus. Autoimmun Rev. 2005 Jun;4(5):296-302. doi: 10.1016/j.autrev.2005.01.003. Epub 2005 Feb 10. PMID 15990077
+Investigators