Back to resultsContinuous Quality Improvement (CQI) Pilot Study Evaluating the Utility of an Educational Video
Primary Purpose
Actinic Keratoses
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Video Group
Verbal Group
Sponsored by
About this trial
This is an interventional health services research trial for Actinic Keratoses
Eligibility Criteria
Inclusion Criteria:
- Subjects with a clinical diagnosis of actinic keratoses with at least 6 clinically-diagnosed actinic keratoses on the face, bald scalp, arms, upper chest, OR dorsal hands classified as grade I, mild (slightly palpable actinic keratoses, more easily felt than seen), and II, moderate (moderately thick hyperkeratotic actinic keratoses, easily felt).
Exclusion Criteria:
- Patients using interferon or interferon inducers, immunomodulators, cytotoxic or immunosuppressor drugs, corticosteroids, retinoids, or investigational drugs within 4 weeks prior to enrollment.
- Patients who have been treated with any topical drug for actinic keratoses lesions less than 8 weeks prior to enrollment.
- Patients with invasive tumors within the treated area (e.g. invasive squamous cell carcinoma)
- Patients who have exhibited any dermatological disease within the treated or adjacent (3 cm distance) area at the time of screening.
- Patients who have known allergies to fluorouracil (5-FU).
Sites / Locations
- University of California-Davis, Department of Dermatology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Video Group
Verbal Group
Arm Description
Subjects view educational video on the use of cream medication for the treatment of actinic keratoses.
Subjects are given verbal instructions on the use of cream medication for the treatment of actinic keratoses.
Outcomes
Primary Outcome Measures
Level of Patient Satisfaction in Relation to Treatment Effects and Expectations of 5-fluorouracil Cream
The level of patient satisfaction will be assessed via questionnaire and visual analog scale.
Secondary Outcome Measures
Full Information
NCT ID
NCT02062853
First Posted
November 26, 2013
Last Updated
July 17, 2017
Sponsor
University of California, Davis
1. Study Identification
Unique Protocol Identification Number
NCT02062853
Brief Title
Continuous Quality Improvement (CQI) Pilot Study Evaluating the Utility of an Educational Video
Official Title
CQI Pilot Study Evaluating the Utility of an Educational Video in the Setting of Topical 5-fluorouracil Therapy to Treat Actinic Keratoses and Its Influence on Patient Satisfaction
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The primary aim of this study is to evaluate the effects of prospective patient education on patient satisfaction with administration of topical 5% 5-fluorouracil cream for the treatment of actinic keratosis involving the face, scalp, upper chest, dorsal hands and forearms. Specifically, this study aims to determine if prospective patient viewing of an educational video delineating treatment effects and expectations improves patient satisfaction and treatment completion rates.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Actinic Keratoses
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Video Group
Arm Type
Experimental
Arm Description
Subjects view educational video on the use of cream medication for the treatment of actinic keratoses.
Arm Title
Verbal Group
Arm Type
Active Comparator
Arm Description
Subjects are given verbal instructions on the use of cream medication for the treatment of actinic keratoses.
Intervention Type
Other
Intervention Name(s)
Video Group
Intervention Description
Subjects will view a brief video today (about 5 minutes long) that provides information on the cream medication that will be used for treatment of your actinic keratoses.
Intervention Type
Other
Intervention Name(s)
Verbal Group
Intervention Description
The physician will provide information about the cream medication for the treatment of actinic keratoses through a regular conversation.
Primary Outcome Measure Information:
Title
Level of Patient Satisfaction in Relation to Treatment Effects and Expectations of 5-fluorouracil Cream
Description
The level of patient satisfaction will be assessed via questionnaire and visual analog scale.
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects with a clinical diagnosis of actinic keratoses with at least 6 clinically-diagnosed actinic keratoses on the face, bald scalp, arms, upper chest, OR dorsal hands classified as grade I, mild (slightly palpable actinic keratoses, more easily felt than seen), and II, moderate (moderately thick hyperkeratotic actinic keratoses, easily felt).
Exclusion Criteria:
Patients using interferon or interferon inducers, immunomodulators, cytotoxic or immunosuppressor drugs, corticosteroids, retinoids, or investigational drugs within 4 weeks prior to enrollment.
Patients who have been treated with any topical drug for actinic keratoses lesions less than 8 weeks prior to enrollment.
Patients with invasive tumors within the treated area (e.g. invasive squamous cell carcinoma)
Patients who have exhibited any dermatological disease within the treated or adjacent (3 cm distance) area at the time of screening.
Patients who have known allergies to fluorouracil (5-FU).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nasim Fazel, M.D., D.D.S.
Organizational Affiliation
University of California, Davis
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California-Davis, Department of Dermatology
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.ucdmc.ucdavis.edu/dermatology/research/clinical
Description
University of California-Davis Department of Dermatology Clinical Research
Learn more about this trial
Continuous Quality Improvement (CQI) Pilot Study Evaluating the Utility of an Educational Video
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