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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01629784
Recruitment Status : Completed
First Posted : June 28, 2012
Results First Posted : June 3, 2013
Last Update Posted : June 3, 2013
Sponsor:
Information provided by (Responsible Party):
Roopal Kundu, Northwestern University

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Cutaneous Lupus Erythematosus Behavioral: Cutaneous Lupus educational script Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Effectiveness of a Knowledge-based Intervention for Patients With Cutaneous Lupus Erythematosus
Study Start Date : May 2012
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
CLE and sun counseling Behavioral: Cutaneous Lupus educational script
Subjects will listen to a short informational script on Cutaneous lupus and skin protection


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Subjects Who Correctly Answered a Knowledge Assessment Item Immediately Before and After an Educational Lecture [ Time Frame: 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 Outcome Measures :
  1. Percentage of Subjects Who Correctly Answered a Knowledge or Behavioral Assessment Item Before and 3 Months After an Educational Lecture [ Time Frame: 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 Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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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): NCT01629784


Locations
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United States, Illinois
Northwestern University Department of Dermatology
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
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Principal Investigator: Roopal Kundu, M.D. Northwestern University
More Information
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Additional Information:

Publications:

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Responsible Party: Roopal Kundu, Assistant Professor of Dermatology, Northwestern University
ClinicalTrials.gov Identifier: NCT01629784    
Other Study ID Numbers: STU65095
First Posted: June 28, 2012    Key Record Dates
Results First Posted: June 3, 2013
Last Update Posted: June 3, 2013
Last Verified: April 2013
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Lupus Erythematosus, Cutaneous
Connective Tissue Diseases
 Autoimmune Diseases
Immune System Diseases
Skin Diseases