Effectiveness of a Knowledge-based Intervention for Patients With Cutaneous Lupus Erythematosus

Cutaneous Lupus Erythematosus Clinical Trial

Official title:

Effectiveness of a Knowledge-based Intervention for Patients With Cutaneous Lupus Erythematosus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01629784
• Other study ID #: STU65095
• Status: Completed
• Phase: N/A
• First received: June 26, 2012
• Last updated: April 15, 2013
• Start date: May 2012
• Est. completion date: January 2013

Study information

• Verified date: April 2013
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Cutaneous Lupus Erythematosus
• Lupus Erythematosus, Cutaneous
• Lupus Erythematosus, Systemic

Intervention

Behavioral:
• Cutaneous Lupus educational script
Subjects will listen to a short informational script on Cutaneous lupus and skin protection

Locations

Country	Name	City	State
United States	Northwestern University Department of Dermatology	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

References & Publications (4)

Finlay AY. Quality of life assessments in dermatology. Semin Cutan Med Surg. 1998 Dec;17(4):291-6. Review. — View Citation

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. — View Citation

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. — View Citation

Werth VP. Clinical manifestations of cutaneous lupus erythematosus. Autoimmun Rev. 2005 Jun;4(5):296-302. Epub 2005 Feb 10. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Subjects Who Correctly Answered a Knowledge Assessment Item 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.	immediately before and after an educational lecture	No
Secondary	Percentage of Subjects Who Correctly Answered a Knowledge or Behavioral Assessment Item 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.	before and 3 months after an educational lecture	No

External Links

•   Northwestern University Department of Dermatology Actively Enrolling Research Trials