Trial Outcomes & Findings for Assessing and Improving Patient Knowledge About Keloid Scars (Keloids) (NCT NCT01176877)

NCT ID: NCT01176877

Last Updated: 2013-01-03

Results Overview

All subjects completed a written questionnaire to assess knowledge about keloid scars before an educational lecture about keloids, immediately after the educational lecture about keloids, and 3 months after the educational lecture about keloids. This written questionnaire to assess knowledge about keloid scars contained 19 questions related to risk factors for developing keloid scars, keloid scar prevention, and keloid scar treatment. A correct response to a question was awarded 1 point and all correct responses were summed to achieve a total score. Possible total score ranged from 0 to 19. A score of 0 is associated with worse knowledge about keloid scars and a score of 19 is associated with better knowledge about keloid scars.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

40 participants

Primary outcome timeframe

immediately before and after a 5 minute educational lecture

Results posted on

2013-01-03

Participant Flow

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.

Participant milestones

Participant milestones
Measure
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.
Overall Study
STARTED
40
Overall Study
COMPLETED
31
Overall Study
NOT COMPLETED
9

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Assessing and Improving Patient Knowledge About Keloid Scars (Keloids)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Keloid Scar
n=40 Participants
Those with a diagnosis of keloid scar.
Age, Categorical
<=18 years
0 Participants
n=99 Participants
Age, Categorical
Between 18 and 65 years
38 Participants
n=99 Participants
Age, Categorical
>=65 years
2 Participants
n=99 Participants
Age Continuous
40 years
n=99 Participants
Sex: Female, Male
Female
28 Participants
n=99 Participants
Sex: Female, Male
Male
12 Participants
n=99 Participants
Region of Enrollment
United States
40 participants
n=99 Participants

PRIMARY outcome

Timeframe: immediately before and after a 5 minute educational lecture

All subjects completed a written questionnaire to assess knowledge about keloid scars before an educational lecture about keloids, immediately after the educational lecture about keloids, and 3 months after the educational lecture about keloids. This written questionnaire to assess knowledge about keloid scars contained 19 questions related to risk factors for developing keloid scars, keloid scar prevention, and keloid scar treatment. A correct response to a question was awarded 1 point and all correct responses were summed to achieve a total score. Possible total score ranged from 0 to 19. A score of 0 is associated with worse knowledge about keloid scars and a score of 19 is associated with better knowledge about keloid scars.

Outcome measures

Outcome measures
Measure
Keloid Scar
n=40 Participants
Participants with keloid scars completed a written questionnaire to assess knowledge about keloid scars. Participants then listened to a scripted, 5 minute educational lecture about keloid scars. Immediately after the educational lecture, the subjects completed an identical written questionnaire to assess knowledge about keloid scars.
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
Pre-educational lecture score
12.9 score on a scale
Interval 5.0 to 19.0
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
Immediate post-educational lecture score
18.3 score on a scale
Interval 14.0 to 19.0

SECONDARY outcome

Timeframe: before and 3 months after a 5 minute educational lecture

Population: Patients enrolled who were available for phone contact 3 months following intervention.

All subjects completed a written questionnaire to assess knowledge about keloid scars before an educational lecture about keloids, immediately after the educational lecture about keloids, and 3 months after the educational lecture about keloids. This written questionnaire to assess knowledge about keloid scars contained 19 questions related to risk factors for developing keloid scars, keloid scar prevention, and keloid scar treatment. A correct response to a question was awarded 1 point and all correct responses were summed to achieve a total score. Possible total score ranged from 0 to 19. A score of 0 is associated with worse knowledge about keloid scars and a score of 19 is associated with better knowledge about keloid scars.

Outcome measures

Outcome measures
Measure
Keloid Scar
n=31 Participants
Participants with keloid scars completed a written questionnaire to assess knowledge about keloid scars. Participants then listened to a scripted, 5 minute educational lecture about keloid scars. Immediately after the educational lecture, the subjects completed an identical written questionnaire to assess knowledge about keloid scars.
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
Pre-educational lecture score
13.2 score on a scale
Interval 5.0 to 19.0
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
3 months post-educational lecture score
16.8 score on a scale
Interval 12.0 to 19.0

Adverse Events

Keloid Scar

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

Dr. Steven Nwe, Clinical Research Fellow

Northwestern University, Feinberg School of Medicine, Department of Dermatology

Phone: 312-695-4625

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place