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Assessing and Improving Patient Knowledge About Keloid Scars (Keloids)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Roopal Kundu, Northwestern University
ClinicalTrials.gov Identifier:
NCT01176877
First received: July 30, 2010
Last updated: November 30, 2012
Last verified: November 2012
History of Changes
Results First Received: August 29, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label
Condition: Keloid Scar
Intervention: Behavioral: Scripted lecture ("educational information talk")

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Between August 2010 and June 2011, 40 subjects were recruited from patients seen for keloid scars at Northwestern University’s dermatology clinic in Chicago, Illinois, and from the general population by advertisements in a local newspaper and Internet classified ads.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Keloid Scar Subjects over the age of 18 with a clinical diagnosis of keloid scarring were included in the study. First, subjects completed a written questionnaire to collect demographic data, including personal history of keloid scarring, past and present use of keloid scar treatments, and internet access and use to find information related to keloid scars. Second, subjects completed a written questionnaire to assess knowledge about keloids. Next, subjects listened to a scripted, 5 minute educational lecture about keloid scars and then completed a written questionnaire to assess knowledge about keloids. Finally, subjects were contacted by phone 3 months later to complete a questionnaire to assess knowledge about keloids and to answer questions about keloid-related behaviors over the previous 3 months.

Participant Flow:   Overall Study
    Keloid Scar  
STARTED     40  
COMPLETED     31  
NOT COMPLETED     9  



  Baseline Characteristics
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Reporting Groups
  Description
Keloid Scar Those with a diagnosis of keloid scar.

Baseline Measures
    Keloid Scar  
Number of Participants  
[units: participants]
 		  40  
Age  
[units: participants]
 		 
<=18 years     0  
Between 18 and 65 years     38  
>=65 years     2  
Age  
[units: years]
Mean ( Inter-Quartile Range ) 		  40  
  ( 29 to 50 )  
Gender  
[units: participants]
 		 
Female     28  
Male     12  
Region of Enrollment  
[units: participants]
 		 
United States     40  



  Outcome Measures
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1.  Primary:   To Assess the Impact of an Educational Lecture on Knowledge About Keloid Scars by Comparing Mean Scores Between Knowledge Assessment Questionnaires Administered Before an Educational Lecture and Immediately After an Educational Lecture   [ Time Frame: immediately before and after a 5 minute educational lecture ]
  Show Outcome Measure 1

2.  Secondary:   To Assess the Impact of an Educational Lecture on Long-term Knowledge Retention About Keloid Scars by Comparing Mean Scores Between Knowledge Assessment Questionnaires Administered Before an Educational Lecture and 3 Months After an Educational Lecture   [ Time Frame: before and 3 months after a 5 minute educational lecture ]
  Show Outcome Measure 2


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
limitation of the study is the accrual of a majority of participants from keloid patients at a single academic center.  


Results Point of Contact:  
Name/Title: Dr. Steven Nwe, Clinical Research Fellow
Organization: Northwestern University, Feinberg School of Medicine, Department of Dermatology
phone: 312-695-4625
e-mail: steven.nwe@northwestern.edu


Publications:


Responsible Party: Roopal Kundu, Northwestern University
ClinicalTrials.gov Identifier: NCT01176877     History of Changes
Other Study ID Numbers: STU32316
Study First Received: July 30, 2010
Results First Received: August 29, 2012
Last Updated: November 30, 2012
Health Authority: United States: Institutional Review Board