Continuous Quality Improvement (CQI) Pilot Study Evaluating the Utility of an Educational Video

Actinic Keratoses Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02062853
• Other study ID #: 384968
• Secondary ID: 384968
• Status: Completed
• Phase: N/A
• First received: November 26, 2013
• Last updated: July 17, 2017
• Start date: November 2012
• Est. completion date: June 2016

Study information

• Verified date: July 2017
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Actinic Keratoses
• Keratosis
• Keratosis, Actinic

Intervention

Other:
• Video Group
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.
• Verbal Group
The physician will provide information about the cream medication for the treatment of actinic keratoses through a regular conversation.

Locations

Country	Name	City	State
United States	University of California-Davis, Department of Dermatology	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 weeks

External Links

•   University of California-Davis Department of Dermatology Clinical Research