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

NCT02062853 | Completed

• 1 other identifier: 384968
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Actinic Keratoses

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Video Group

EXPERIMENTAL

Subjects view educational video on the use of cream medication for the treatment of actinic keratoses.

Other: Video Group

Verbal Group

ACTIVE COMPARATOR

Subjects are given verbal instructions on the use of cream medication for the treatment of actinic keratoses.

Other: Verbal Group

Interventions

Video Group OTHER

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.

Video Group

Verbal Group OTHER

The physician will provide information about the cream medication for the treatment of actinic keratoses through a regular conversation.

Verbal Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

University of California-Davis, Department of Dermatology

Sacramento, California, 95816, United States

Location

Related Links

• University of California-Davis Department of Dermatology Clinical Research

MeSH Terms

Conditions

Keratosis, Actinic

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Nasim Fazel, M.D., D.D.S.

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2013
• First Posted: February 14, 2014
• Study Start: November 1, 2012
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: July 19, 2017

Record last verified: 2017-07

Locations

US (1)