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

• Sponsor: Northwestern University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01629784
• Collaborator: (none)
• Enrollment: 31
• Location: 1
• Arm: 1
• Duration (Months): 8
• Patients Per Site Per Month: 3.9

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• 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 1, 2012
• Actual Primary Completion Date: Jan 1, 2013
• Actual Study Completion Date: Jan 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Other: 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

Primary Outcome Measures

1. 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 Outcome Measures

1. 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 Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Northwestern University Department of Dermatology	Chicago	Illinois	United States	60611

Sponsors and Collaborators

• Northwestern University

Investigators

• Principal Investigator: Roopal Kundu, M.D., Northwestern University

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Northwestern University Department of Dermatology Actively Enrolling Research Trials

Publications

• Finlay AY. Quality of life assessments in dermatology. Semin Cutan Med Surg. 1998 Dec;17(4):291-6. Review.
• 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.
• 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.
• Werth VP. Clinical manifestations of cutaneous lupus erythematosus. Autoimmun Rev. 2005 Jun;4(5):296-302. Epub 2005 Feb 10. Review.

• Responsible Party: Roopal Kundu, Assistant Professor of Dermatology, Northwestern University
• ClinicalTrials.gov Identifier: NCT01629784
• Other Study ID Numbers: STU65095
• First Posted: Jun 28, 2012
• Last Update Posted: Jun 3, 2013
• Last Verified: Apr 1, 2013

• Additional relevant MeSH terms: Lupus Erythematosus, Systemic; Lupus Erythematosus, Cutaneous

Study Results

Participant Flow

Recruitment Details	Adult subjects with cutaneous lupus erythematosus (CLE) were recruited from Northwestern University's dermatology and rheumatology clinics.

Arm/Group Title	Cutaneous Lupus Erythematosus (CLE)
Arm/Group Description	Subjects completed a written questionnaire to collect demographic data, including personal history of CLE and sun protection behaviors, and to assess knowledge about CLE and sun protection. Next, subjects listened to a scripted, educational lecture about CLE and sun protection, and then immediately completed a post-lecture written questionnaire to assess knowledge about CLE and sun protection. Three months after the educational lecture, subjects were contacted by phone to complete a final knowledge and behavioral assessment.
Period Title: Overall Study
STARTED	31
COMPLETED	25
NOT COMPLETED	6

Baseline Characteristics

Arm/Group Title	Cutaneous Lupus Erythematosus (CLE)
Arm/Group Description	Subjects completed a written questionnaire to collect demographic data, including personal history of CLE and sun protection behaviors, and to assess knowledge about CLE and sun protection. Next, subjects listened to a scripted, educational lecture about CLE and sun protection, and then immediately completed a post-lecture written questionnaire to assess knowledge about CLE and sun protection. Three months after the educational lecture, subjects were contacted by phone to complete a final knowledge and behavioral assessment.
Overall Participants	31
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	28 90.3%
>=65 years	3 9.7%
Sex: Female, Male (Count of Participants)
Female	26 83.9%
Male	5 16.1%
Region of Enrollment (participants) [Number]
United States	31 100%

Outcome Measures

1. Primary Outcome

Title	Percentage of Subjects Who Correctly Answered a Knowledge Assessment Item Immediately Before and After an Educational Lecture
Description	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.
Time Frame	immediately before and after an educational lecture

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pre-educational Lecture	Post-educational Lecture
Arm/Group Description	Subjects completed a written questionnaire to collect demographic data, including personal history of CLE and sun protection behaviors, and to assess knowledge about CLE and sun protection. Next, subjects listened to a scripted, educational lecture about CLE and sun protection, and then immediately completed a written questionnaire to assess knowledge about CLE and sun protection.	Subjects completed a written questionnaire to collect demographic data, including personal history of CLE and sun protection behaviors, and to assess knowledge about CLE and sun protection. Next, subjects listened to a scripted, educational lecture about CLE and sun protection, and then immediately completed a written questionnaire to assess knowledge about CLE and sun protection.
Measure Participants	31	31
Risk of lupus for people of color	52 167.7%	94 NaN
Smoking linked to lupus	19 61.3%	90 NaN
Sun exposure linked to lupus	81 261.3%	97 NaN
Sun brings out lupus lesions	74 238.7%	97 NaN
Should use sun-protective clothing to protect skin	94 303.2%	100 NaN
Should apply sunscreen before going outdoors	97 312.9%	100 NaN
Time to apply sunscreen before sun exposure	39 125.8%	48 NaN
Type of sunscreen that should be used	87 280.6%	90 NaN
Exposure to UV rays while indoors through glass	68 219.4%	100 NaN
Exposure to UV rays with indoor tanning	39 125.8%	100 NaN
Should apply sunscreen under makeup	68 219.4%	100 NaN
Should avoid sun during hours of 10 am - 2 pm	84 271%	100 NaN

2. Secondary Outcome

Title	Percentage of Subjects Who Correctly Answered a Knowledge or Behavioral Assessment Item Before and 3 Months After an Educational Lecture
Description	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.
Time Frame	before and 3 months after an educational lecture

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pre-educational Lecture	Three Months Post-educational Lecture
Arm/Group Description	Subjects completed a written questionnaire to collect demographic data, including personal history of CLE and sun protection behaviors, and to assess knowledge about CLE and sun protection. Next, subjects listened to a scripted, educational lecture about CLE and sun protection. 3 months later, subjects were contacted by phone to complete a knowledge and behavioral assessment about CLE and sun protection.	Subjects completed a written questionnaire to collect demographic data, including personal history of CLE and sun protection behaviors, and to assess knowledge about CLE and sun protection. Next, subjects listened to a scripted, educational lecture about CLE and sun protection. 3 months later, subjects were contacted by phone to complete a knowledge and behavioral assessment about CLE and sun protection.
Measure Participants	31	25
Smoking linked to lupus	19 61.3%	45 NaN
Sun exposure linked to lupus	81 261.3%	77 NaN
Sun brings out lupus lesions	74 238.7%	77 NaN
Should use sun-protective clothing to protect skin	94 303.2%	71 NaN
Seek medical care for change in rash appearance	97 312.9%	81 NaN
Apply sunscreen before going outdoors	71 229%	71 NaN
Apply sunscreen at correct time prior to exposure	32 103.2%	45 NaN
Apply correct type of sunscreen	58 187.1%	58 NaN
Reapply sunscreen at correct time if dry	19 61.3%	13 NaN
Reapply sunscreen at correct time if wet	23 74.2%	19 NaN
Avoid more than two hours of sun exposure	25 80.6%	26 NaN
Limit outdoor social gatherings	55 177.4%	48 NaN
Wear sun-protective clothing	68 219.4%	81 NaN
Avoid indoor tanning	94 303.2%	81 NaN
Apply sunscreen under makeup	45 145.2%	52 NaN
Avoid sun exposure between 10 am - 2 pm	71 229%	71 NaN

Adverse Events

Arm/Group Title	Cutaneous Lupus Erythematosus (CLE)
Arm/Group Description	Subjects completed a written questionnaire to collect demographic data, including personal history of CLE and sun protection behaviors, and to assess knowledge about CLE and sun protection. Next, subjects listened to a scripted, educational lecture about CLE and sun protection, and then immediately completed a post-lecture written questionnaire to assess knowledge about CLE and sun protection. Three months after the educational lecture, subjects were contacted by phone to complete a final knowledge and behavioral assessment.
All Cause Mortality
	Cutaneous Lupus Erythematosus (CLE)
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Cutaneous Lupus Erythematosus (CLE)
	Affected / at Risk (%)	# Events
Total	0/31 (0%)
Other (Not Including Serious) Adverse Events
	Cutaneous Lupus Erythematosus (CLE)
	Affected / at Risk (%)	# Events
Total	0/31 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.