Trial Outcomes & Findings for Effectiveness of a Knowledge-based Intervention for Patients With Cutaneous Lupus Erythematosus (NCT NCT01629784)

Last Updated: 2013-06-03

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

31 participants

Primary outcome timeframe

immediately before and after an educational lecture

Results posted on

2013-06-03

Participant Flow

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

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	31
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cutaneous Lupus Erythematosus (CLE) n=31 Participants 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.
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	28 Participants n=99 Participants
Age, Categorical >=65 years	3 Participants n=99 Participants
Sex: Female, Male Female	26 Participants n=99 Participants
Sex: Female, Male Male	5 Participants n=99 Participants
Region of Enrollment United States	31 participants n=99 Participants

PRIMARY outcome

Timeframe: immediately before and after an educational lecture

Outcome measures

Outcome measures
Measure	Pre-educational Lecture n=31 Participants 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.	Post-educational Lecture n=31 Participants 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.
Percentage of Subjects Who Correctly Answered a Knowledge Assessment Item Immediately Before and After an Educational Lecture Risk of lupus for people of color	52 percentage of participants	94 percentage of participants
Percentage of Subjects Who Correctly Answered a Knowledge Assessment Item Immediately Before and After an Educational Lecture Smoking linked to lupus	19 percentage of participants	90 percentage of participants
Percentage of Subjects Who Correctly Answered a Knowledge Assessment Item Immediately Before and After an Educational Lecture Sun exposure linked to lupus	81 percentage of participants	97 percentage of participants
Percentage of Subjects Who Correctly Answered a Knowledge Assessment Item Immediately Before and After an Educational Lecture Sun brings out lupus lesions	74 percentage of participants	97 percentage of participants
Percentage of Subjects Who Correctly Answered a Knowledge Assessment Item Immediately Before and After an Educational Lecture Should use sun-protective clothing to protect skin	94 percentage of participants	100 percentage of participants
Percentage of Subjects Who Correctly Answered a Knowledge Assessment Item Immediately Before and After an Educational Lecture Should apply sunscreen before going outdoors	97 percentage of participants	100 percentage of participants
Percentage of Subjects Who Correctly Answered a Knowledge Assessment Item Immediately Before and After an Educational Lecture Time to apply sunscreen before sun exposure	39 percentage of participants	48 percentage of participants
Percentage of Subjects Who Correctly Answered a Knowledge Assessment Item Immediately Before and After an Educational Lecture Type of sunscreen that should be used	87 percentage of participants	90 percentage of participants
Percentage of Subjects Who Correctly Answered a Knowledge Assessment Item Immediately Before and After an Educational Lecture Exposure to UV rays while indoors through glass	68 percentage of participants	100 percentage of participants
Percentage of Subjects Who Correctly Answered a Knowledge Assessment Item Immediately Before and After an Educational Lecture Exposure to UV rays with indoor tanning	39 percentage of participants	100 percentage of participants
Percentage of Subjects Who Correctly Answered a Knowledge Assessment Item Immediately Before and After an Educational Lecture Should apply sunscreen under makeup	68 percentage of participants	100 percentage of participants
Percentage of Subjects Who Correctly Answered a Knowledge Assessment Item Immediately Before and After an Educational Lecture Should avoid sun during hours of 10 am - 2 pm	84 percentage of participants	100 percentage of participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Pre-educational Lecture n=31 Participants 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.	Post-educational Lecture n=25 Participants 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.
Percentage of Subjects Who Correctly Answered a Knowledge or Behavioral Assessment Item Before and 3 Months After an Educational Lecture Smoking linked to lupus	19 percentage of participants	45 percentage of participants
Percentage of Subjects Who Correctly Answered a Knowledge or Behavioral Assessment Item Before and 3 Months After an Educational Lecture Sun exposure linked to lupus	81 percentage of participants	77 percentage of participants
Percentage of Subjects Who Correctly Answered a Knowledge or Behavioral Assessment Item Before and 3 Months After an Educational Lecture Sun brings out lupus lesions	74 percentage of participants	77 percentage of participants
Percentage of Subjects Who Correctly Answered a Knowledge or Behavioral Assessment Item Before and 3 Months After an Educational Lecture Should use sun-protective clothing to protect skin	94 percentage of participants	71 percentage of participants
Percentage of Subjects Who Correctly Answered a Knowledge or Behavioral Assessment Item Before and 3 Months After an Educational Lecture Seek medical care for change in rash appearance	97 percentage of participants	81 percentage of participants
Percentage of Subjects Who Correctly Answered a Knowledge or Behavioral Assessment Item Before and 3 Months After an Educational Lecture Apply sunscreen before going outdoors	71 percentage of participants	71 percentage of participants
Percentage of Subjects Who Correctly Answered a Knowledge or Behavioral Assessment Item Before and 3 Months After an Educational Lecture Apply sunscreen at correct time prior to exposure	32 percentage of participants	45 percentage of participants
Percentage of Subjects Who Correctly Answered a Knowledge or Behavioral Assessment Item Before and 3 Months After an Educational Lecture Apply correct type of sunscreen	58 percentage of participants	58 percentage of participants
Percentage of Subjects Who Correctly Answered a Knowledge or Behavioral Assessment Item Before and 3 Months After an Educational Lecture Reapply sunscreen at correct time if dry	19 percentage of participants	13 percentage of participants
Percentage of Subjects Who Correctly Answered a Knowledge or Behavioral Assessment Item Before and 3 Months After an Educational Lecture Reapply sunscreen at correct time if wet	23 percentage of participants	19 percentage of participants
Percentage of Subjects Who Correctly Answered a Knowledge or Behavioral Assessment Item Before and 3 Months After an Educational Lecture Avoid more than two hours of sun exposure	25 percentage of participants	26 percentage of participants
Percentage of Subjects Who Correctly Answered a Knowledge or Behavioral Assessment Item Before and 3 Months After an Educational Lecture Limit outdoor social gatherings	55 percentage of participants	48 percentage of participants
Percentage of Subjects Who Correctly Answered a Knowledge or Behavioral Assessment Item Before and 3 Months After an Educational Lecture Wear sun-protective clothing	68 percentage of participants	81 percentage of participants
Percentage of Subjects Who Correctly Answered a Knowledge or Behavioral Assessment Item Before and 3 Months After an Educational Lecture Avoid indoor tanning	94 percentage of participants	81 percentage of participants
Percentage of Subjects Who Correctly Answered a Knowledge or Behavioral Assessment Item Before and 3 Months After an Educational Lecture Apply sunscreen under makeup	45 percentage of participants	52 percentage of participants
Percentage of Subjects Who Correctly Answered a Knowledge or Behavioral Assessment Item Before and 3 Months After an Educational Lecture Avoid sun exposure between 10 am - 2 pm	71 percentage of participants	71 percentage of participants

Adverse Events

Cutaneous Lupus Erythematosus (CLE)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Hae Bae, CRCC

Northwestern University

Phone: 312-695-6829

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place