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Trial record 17 of 906 for:    Lupus

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 Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label)
Condition Cutaneous Lupus Erythematosus
Intervention Behavioral: Cutaneous Lupus educational script
Enrollment 31
Recruitment Details Adult subjects with cutaneous lupus erythematosus (CLE) were recruited from Northwestern University's dermatology and rheumatology clinics.
Pre-assignment Details  
Arm/Group Title Cutaneous Lupus Erythematosus (CLE)
Hide 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
Arm/Group Title Cutaneous Lupus Erythematosus (CLE)
Hide 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 Number of Baseline Participants 31
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants
<=18 years
0
   0.0%
Between 18 and 65 years
28
  90.3%
>=65 years
3
   9.7%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants
Female
26
  83.9%
Male
5
  16.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 31 participants
31
1.Primary Outcome
Title Percentage of Subjects Who Correctly Answered a Knowledge Assessment Item Immediately Before and After an Educational Lecture
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pre-educational Lecture Post-educational Lecture
Hide 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.
Overall Number of Participants Analyzed 31 31
Measure Type: Number
Unit of Measure: percentage of participants
Risk of lupus for people of color 52 94
Smoking linked to lupus 19 90
Sun exposure linked to lupus 81 97
Sun brings out lupus lesions 74 97
Should use sun-protective clothing to protect skin 94 100
Should apply sunscreen before going outdoors 97 100
Time to apply sunscreen before sun exposure 39 48
Type of sunscreen that should be used 87 90
Exposure to UV rays while indoors through glass 68 100
Exposure to UV rays with indoor tanning 39 100
Should apply sunscreen under makeup 68 100
Should avoid sun during hours of 10 am - 2 pm 84 100
2.Secondary Outcome
Title Percentage of Subjects Who Correctly Answered a Knowledge or Behavioral Assessment Item Before and 3 Months After an Educational Lecture
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pre-educational Lecture Three Months Post-educational Lecture
Hide 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.
Overall Number of Participants Analyzed 31 25
Measure Type: Number
Unit of Measure: percentage of participants
Smoking linked to lupus 19 45
Sun exposure linked to lupus 81 77
Sun brings out lupus lesions 74 77
Should use sun-protective clothing to protect skin 94 71
Seek medical care for change in rash appearance 97 81
Apply sunscreen before going outdoors 71 71
Apply sunscreen at correct time prior to exposure 32 45
Apply correct type of sunscreen 58 58
Reapply sunscreen at correct time if dry 19 13
Reapply sunscreen at correct time if wet 23 19
Avoid more than two hours of sun exposure 25 26
Limit outdoor social gatherings 55 48
Wear sun-protective clothing 68 81
Avoid indoor tanning 94 81
Apply sunscreen under makeup 45 52
Avoid sun exposure between 10 am - 2 pm 71 71
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cutaneous Lupus Erythematosus (CLE)
Hide 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 (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Cutaneous Lupus Erythematosus (CLE)
Affected / at Risk (%)
Total   0/31 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cutaneous Lupus Erythematosus (CLE)
Affected / at Risk (%)
Total   0/31 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Hae Bae, CRCC
Organization: Northwestern University
Phone: 312-695-6829
EMail: j-bae@northwestern.edu
Layout table for additonal information
Responsible Party: Roopal Kundu, Northwestern University
ClinicalTrials.gov Identifier: NCT01629784     History of Changes
Other Study ID Numbers: STU65095
First Submitted: June 26, 2012
First Posted: June 28, 2012
Results First Submitted: April 15, 2013
Results First Posted: June 3, 2013
Last Update Posted: June 3, 2013