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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Roopal Kundu, Northwestern University
ClinicalTrials.gov Identifier:
NCT01629784
First received: June 26, 2012
Last updated: April 15, 2013
Last verified: April 2013
  Purpose

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 Intervention
Cutaneous Lupus Erythematosus
Behavioral: Cutaneous Lupus educational script

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Effectiveness of a Knowledge-based Intervention for Patients With Cutaneous Lupus Erythematosus

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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:
  • 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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 31
Study Start Date: May 2012
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
CLE and sun counseling Behavioral: Cutaneous Lupus educational script
Subjects will listen to a short informational script on Cutaneous lupus and skin protection

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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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Please refer to this study by its ClinicalTrials.gov identifier: NCT01629784

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

Additional Information:
Publications:
Responsible Party: Roopal Kundu, Assistant Professor of Dermatology, Northwestern University
ClinicalTrials.gov Identifier: NCT01629784     History of Changes
Other Study ID Numbers: STU65095
Study First Received: June 26, 2012
Results First Received: April 15, 2013
Last Updated: April 15, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Lupus Erythematosus, Cutaneous
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 29, 2014