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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01629784
Enrollment
31
Registered
2012-06-28
Start date
2012-05-31
Completion date
2013-01-31
Last updated
2013-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cutaneous Lupus Erythematosus

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.

Interventions

BEHAVIORALCutaneous Lupus educational script

Subjects will listen to a short informational script on Cutaneous lupus and skin protection

Sponsors

Northwestern University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Percentage of Subjects Who Correctly Answered a Knowledge Assessment Item Immediately Before and After an Educational Lectureimmediately before and after an educational lectureIn 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

MeasureTime frameDescription
Percentage of Subjects Who Correctly Answered a Knowledge or Behavioral Assessment Item Before and 3 Months After an Educational Lecturebefore and 3 months after an educational lectureIn 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.

Countries

United States

Participant flow

Recruitment details

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

Participants by arm

ArmCount
Cutaneous Lupus Erythematosus (CLE)
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.
31
Total31

Baseline characteristics

CharacteristicCutaneous Lupus Erythematosus (CLE)
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
3 Participants
Age, Categorical
Between 18 and 65 years
28 Participants
Region of Enrollment
United States
31 participants
Sex: Female, Male
Female
26 Participants
Sex: Female, Male
Male
5 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
0 / 31
serious
Total, serious adverse events
0 / 31

Outcome results

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.

Time frame: immediately before and after an educational lecture

ArmMeasureGroupValue (NUMBER)
Pre-educational LecturePercentage of Subjects Who Correctly Answered a Knowledge Assessment Item Immediately Before and After an Educational LectureSun exposure linked to lupus81 percentage of participants
Pre-educational LecturePercentage of Subjects Who Correctly Answered a Knowledge Assessment Item Immediately Before and After an Educational LectureExposure to UV rays with indoor tanning39 percentage of participants
Pre-educational LecturePercentage of Subjects Who Correctly Answered a Knowledge Assessment Item Immediately Before and After an Educational LectureShould use sun-protective clothing to protect skin94 percentage of participants
Pre-educational LecturePercentage of Subjects Who Correctly Answered a Knowledge Assessment Item Immediately Before and After an Educational LectureShould apply sunscreen under makeup68 percentage of participants
Pre-educational LecturePercentage of Subjects Who Correctly Answered a Knowledge Assessment Item Immediately Before and After an Educational LectureShould avoid sun during hours of 10 am - 2 pm84 percentage of participants
Pre-educational LecturePercentage of Subjects Who Correctly Answered a Knowledge Assessment Item Immediately Before and After an Educational LectureSmoking linked to lupus19 percentage of participants
Pre-educational LecturePercentage of Subjects Who Correctly Answered a Knowledge Assessment Item Immediately Before and After an Educational LectureRisk of lupus for people of color52 percentage of participants
Pre-educational LecturePercentage of Subjects Who Correctly Answered a Knowledge Assessment Item Immediately Before and After an Educational LectureShould apply sunscreen before going outdoors97 percentage of participants
Pre-educational LecturePercentage of Subjects Who Correctly Answered a Knowledge Assessment Item Immediately Before and After an Educational LectureType of sunscreen that should be used87 percentage of participants
Pre-educational LecturePercentage of Subjects Who Correctly Answered a Knowledge Assessment Item Immediately Before and After an Educational LectureTime to apply sunscreen before sun exposure39 percentage of participants
Pre-educational LecturePercentage of Subjects Who Correctly Answered a Knowledge Assessment Item Immediately Before and After an Educational LectureSun brings out lupus lesions74 percentage of participants
Pre-educational LecturePercentage of Subjects Who Correctly Answered a Knowledge Assessment Item Immediately Before and After an Educational LectureExposure to UV rays while indoors through glass68 percentage of participants
Post-educational LecturePercentage of Subjects Who Correctly Answered a Knowledge Assessment Item Immediately Before and After an Educational LectureShould apply sunscreen under makeup100 percentage of participants
Post-educational LecturePercentage of Subjects Who Correctly Answered a Knowledge Assessment Item Immediately Before and After an Educational LectureSmoking linked to lupus90 percentage of participants
Post-educational LecturePercentage of Subjects Who Correctly Answered a Knowledge Assessment Item Immediately Before and After an Educational LectureSun exposure linked to lupus97 percentage of participants
Post-educational LecturePercentage of Subjects Who Correctly Answered a Knowledge Assessment Item Immediately Before and After an Educational LectureSun brings out lupus lesions97 percentage of participants
Post-educational LecturePercentage of Subjects Who Correctly Answered a Knowledge Assessment Item Immediately Before and After an Educational LectureShould use sun-protective clothing to protect skin100 percentage of participants
Post-educational LecturePercentage of Subjects Who Correctly Answered a Knowledge Assessment Item Immediately Before and After an Educational LectureType of sunscreen that should be used90 percentage of participants
Post-educational LecturePercentage of Subjects Who Correctly Answered a Knowledge Assessment Item Immediately Before and After an Educational LectureExposure to UV rays while indoors through glass100 percentage of participants
Post-educational LecturePercentage of Subjects Who Correctly Answered a Knowledge Assessment Item Immediately Before and After an Educational LectureExposure to UV rays with indoor tanning100 percentage of participants
Post-educational LecturePercentage of Subjects Who Correctly Answered a Knowledge Assessment Item Immediately Before and After an Educational LectureShould avoid sun during hours of 10 am - 2 pm100 percentage of participants
Post-educational LecturePercentage of Subjects Who Correctly Answered a Knowledge Assessment Item Immediately Before and After an Educational LectureShould apply sunscreen before going outdoors100 percentage of participants
Post-educational LecturePercentage of Subjects Who Correctly Answered a Knowledge Assessment Item Immediately Before and After an Educational LectureTime to apply sunscreen before sun exposure48 percentage of participants
Post-educational LecturePercentage of Subjects Who Correctly Answered a Knowledge Assessment Item Immediately Before and After an Educational LectureRisk of lupus for people of color94 percentage of participants
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.

Time frame: before and 3 months after an educational lecture

ArmMeasureGroupValue (NUMBER)
Pre-educational LecturePercentage of Subjects Who Correctly Answered a Knowledge or Behavioral Assessment Item Before and 3 Months After an Educational LectureSmoking linked to lupus19 percentage of participants
Pre-educational LecturePercentage of Subjects Who Correctly Answered a Knowledge or Behavioral Assessment Item Before and 3 Months After an Educational LectureSun exposure linked to lupus81 percentage of participants
Pre-educational LecturePercentage of Subjects Who Correctly Answered a Knowledge or Behavioral Assessment Item Before and 3 Months After an Educational LectureSun brings out lupus lesions74 percentage of participants
Pre-educational LecturePercentage of Subjects Who Correctly Answered a Knowledge or Behavioral Assessment Item Before and 3 Months After an Educational LectureApply correct type of sunscreen58 percentage of participants
Pre-educational LecturePercentage of Subjects Who Correctly Answered a Knowledge or Behavioral Assessment Item Before and 3 Months After an Educational LectureReapply sunscreen at correct time if dry19 percentage of participants
Pre-educational LecturePercentage of Subjects Who Correctly Answered a Knowledge or Behavioral Assessment Item Before and 3 Months After an Educational LectureReapply sunscreen at correct time if wet23 percentage of participants
Pre-educational LecturePercentage of Subjects Who Correctly Answered a Knowledge or Behavioral Assessment Item Before and 3 Months After an Educational LectureAvoid more than two hours of sun exposure25 percentage of participants
Pre-educational LecturePercentage of Subjects Who Correctly Answered a Knowledge or Behavioral Assessment Item Before and 3 Months After an Educational LectureAvoid sun exposure between 10 am - 2 pm71 percentage of participants
Pre-educational LecturePercentage of Subjects Who Correctly Answered a Knowledge or Behavioral Assessment Item Before and 3 Months After an Educational LectureShould use sun-protective clothing to protect skin94 percentage of participants
Pre-educational LecturePercentage of Subjects Who Correctly Answered a Knowledge or Behavioral Assessment Item Before and 3 Months After an Educational LectureSeek medical care for change in rash appearance97 percentage of participants
Pre-educational LecturePercentage of Subjects Who Correctly Answered a Knowledge or Behavioral Assessment Item Before and 3 Months After an Educational LectureApply sunscreen before going outdoors71 percentage of participants
Pre-educational LecturePercentage of Subjects Who Correctly Answered a Knowledge or Behavioral Assessment Item Before and 3 Months After an Educational LectureApply sunscreen at correct time prior to exposure32 percentage of participants
Pre-educational LecturePercentage of Subjects Who Correctly Answered a Knowledge or Behavioral Assessment Item Before and 3 Months After an Educational LectureLimit outdoor social gatherings55 percentage of participants
Pre-educational LecturePercentage of Subjects Who Correctly Answered a Knowledge or Behavioral Assessment Item Before and 3 Months After an Educational LectureWear sun-protective clothing68 percentage of participants
Pre-educational LecturePercentage of Subjects Who Correctly Answered a Knowledge or Behavioral Assessment Item Before and 3 Months After an Educational LectureAvoid indoor tanning94 percentage of participants
Pre-educational LecturePercentage of Subjects Who Correctly Answered a Knowledge or Behavioral Assessment Item Before and 3 Months After an Educational LectureApply sunscreen under makeup45 percentage of participants
Post-educational LecturePercentage of Subjects Who Correctly Answered a Knowledge or Behavioral Assessment Item Before and 3 Months After an Educational LectureAvoid sun exposure between 10 am - 2 pm71 percentage of participants
Post-educational LecturePercentage of Subjects Who Correctly Answered a Knowledge or Behavioral Assessment Item Before and 3 Months After an Educational LectureSmoking linked to lupus45 percentage of participants
Post-educational LecturePercentage of Subjects Who Correctly Answered a Knowledge or Behavioral Assessment Item Before and 3 Months After an Educational LectureApply sunscreen at correct time prior to exposure45 percentage of participants
Post-educational LecturePercentage of Subjects Who Correctly Answered a Knowledge or Behavioral Assessment Item Before and 3 Months After an Educational LectureSun exposure linked to lupus77 percentage of participants
Post-educational LecturePercentage of Subjects Who Correctly Answered a Knowledge or Behavioral Assessment Item Before and 3 Months After an Educational LectureShould use sun-protective clothing to protect skin71 percentage of participants
Post-educational LecturePercentage of Subjects Who Correctly Answered a Knowledge or Behavioral Assessment Item Before and 3 Months After an Educational LectureSun brings out lupus lesions77 percentage of participants
Post-educational LecturePercentage of Subjects Who Correctly Answered a Knowledge or Behavioral Assessment Item Before and 3 Months After an Educational LectureAvoid indoor tanning81 percentage of participants
Post-educational LecturePercentage of Subjects Who Correctly Answered a Knowledge or Behavioral Assessment Item Before and 3 Months After an Educational LectureApply correct type of sunscreen58 percentage of participants
Post-educational LecturePercentage of Subjects Who Correctly Answered a Knowledge or Behavioral Assessment Item Before and 3 Months After an Educational LectureSeek medical care for change in rash appearance81 percentage of participants
Post-educational LecturePercentage of Subjects Who Correctly Answered a Knowledge or Behavioral Assessment Item Before and 3 Months After an Educational LectureReapply sunscreen at correct time if dry13 percentage of participants
Post-educational LecturePercentage of Subjects Who Correctly Answered a Knowledge or Behavioral Assessment Item Before and 3 Months After an Educational LectureLimit outdoor social gatherings48 percentage of participants
Post-educational LecturePercentage of Subjects Who Correctly Answered a Knowledge or Behavioral Assessment Item Before and 3 Months After an Educational LectureReapply sunscreen at correct time if wet19 percentage of participants
Post-educational LecturePercentage of Subjects Who Correctly Answered a Knowledge or Behavioral Assessment Item Before and 3 Months After an Educational LectureApply sunscreen before going outdoors71 percentage of participants
Post-educational LecturePercentage of Subjects Who Correctly Answered a Knowledge or Behavioral Assessment Item Before and 3 Months After an Educational LectureAvoid more than two hours of sun exposure26 percentage of participants
Post-educational LecturePercentage of Subjects Who Correctly Answered a Knowledge or Behavioral Assessment Item Before and 3 Months After an Educational LectureApply sunscreen under makeup52 percentage of participants
Post-educational LecturePercentage of Subjects Who Correctly Answered a Knowledge or Behavioral Assessment Item Before and 3 Months After an Educational LectureWear sun-protective clothing81 percentage of participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026