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

Not Applicable

Completed

• Conditions: Actinic Keratoses
• Interventions: Other: Verbal Group; Other: Video Group

• Registration Number: NCT02062853
• Lead Sponsor: University of California, Davis

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2013-11-26
• Study First Submitted QC: 2014-02-12
• Study First Posted: 2014-02-14
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-17
• Last Update Posted: 2017-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Verbal Group	Verbal Group	Subjects are given verbal instructions on the use of cream medication for the treatment of actinic keratoses.
Video Group	Video Group	Subjects view educational video on the use of cream medication for the treatment of actinic keratoses.

Primary Outcome Measures

Name	Time	Method
Level of Patient Satisfaction in Relation to Treatment Effects and Expectations of 5-fluorouracil Cream	4 weeks	The level of patient satisfaction will be assessed via questionnaire and visual analog scale.

Trial Locations

Locations (1)

University of California-Davis, Department of Dermatology; 🇺🇸 Sacramento, California, United States