Pilot Study of the Pragmatic Use of Mobile Phone Based Follow up of Actinic Keratoses Treated With Topical 5-fluorouracil
Primary Purpose
Actinic Keratosis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
teledermatology feedback
Sponsored by
About this trial
This is an interventional other trial for Actinic Keratosis
Eligibility Criteria
Inclusion Criteria:
- Subjects 18 years of age or older
- Subjects who have already been prescribed topical 5-fluorouracil for treatment of scalp, facial, arm, or hand actinic keratoses but have not initiated treatment yet
Exclusion Criteria:
- Adults unable to consent
- Non English speaking or illiterate
- Subjects with known allergy to 5-fluorouracil
- Subjects who do not have access to a smartphone capable of engaging with the online teledermatology platform
- Pregnant women
- Prisoners
Sites / Locations
- UC Davis Department of Dermatology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Feedback group (teledermatology)
Control group (phone only)
Arm Description
Outcomes
Primary Outcome Measures
Difference in total dose of exposure to 5-FU between teledermatology and control group (measured as days of exposure x frequency of application per day)
The total exposure to 5-FU will be calculated as total doses over 4 week period.
Secondary Outcome Measures
Patient satisfaction assessment
Change in clinical grading of actinic keratoses
Change in AK lesion count
Change in severity of symptoms
Difference in adverse effects including erythema, pruritus, burning, soreness, and/or tenderness, crusting and/or erosions, scaling and/or flaking, and swelling
Difference in number of clinic visits between the 2 groups
Full Information
NCT ID
NCT02938715
First Posted
October 17, 2016
Last Updated
January 11, 2018
Sponsor
University of California, Davis
1. Study Identification
Unique Protocol Identification Number
NCT02938715
Brief Title
Pilot Study of the Pragmatic Use of Mobile Phone Based Follow up of Actinic Keratoses Treated With Topical 5-fluorouracil
Official Title
Pilot Study of the Pragmatic Use of Mobile Phone Based Follow up of Actinic Keratoses Treated With Topical 5-fluorouracil
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
October 2016 (Actual)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
September 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis
4. Oversight
5. Study Description
Brief Summary
In this study, subjects who are attending the dermatology clinic and who have already been prescribed topical 5-fluorouracial for the treatment of actinic keratoses as part of their standard of care will be recruited. The purpose of the study is to assess patient satisfaction when engaging in follow up treatment of actinic keratosis via the HIPAA-compliant teledermatology platform called Klara. Additionally, the goal is to assess the difference in total duration of treatment between treatment and control group. A total of 50 subjects will be enrolled and will be randomly assigned into the treatment group (teledermatology group; n=25) or control group (telephone only group; n=25).
Detailed Description
Objectives
To assess patient satisfaction when engaging in follow up treatment of actinic keratoses: Follow up of subjects with actinic keratoses (AK) who have been prescribed topical 5-fluorouracil (5-FU) therapy as part of their standard of care.
To assess the difference in total dose of exposure to 5-FU between treatment and control group.
Background
Teledermatology is a growing field within dermatology that has started to adapt the use of mobile phone technology (1). The growth of teledermatology has allowed greater access to care in both the inpatient and outpatient setting (1, 2), as well as in educational services (3). The aim of this study is to investigate how mobile phone photographic teledermatology can be adapted for use in the dermatology clinic to continually engage with the patient. More specifically, the researchers seek to understand how mobile phone technology can be used in the evaluation of subjects on topical 5-FU therapy for their actinic keratoses.
Diffuse actinic damage is typically treated with field therapy (4) that involves the use of topical 5-FU. Patients are advised to apply the cream twice daily for 2-4 weeks (5). However, many patients note misunderstanding with these instructions (6). Typical follow up has included telephone based grading and in person follow up (5). However, a return visit to the clinic can be both burdensome to the patient and fill up the clinic with follow up appointments instead of allowing the appointment slot to go to examination of a new patient, thereby reducing access to care for other patients. Telephone conversations are not based on a physical exam and thus do not allow for objective evaluation of the treatment area. For this reason, the researchers seek to use mobile phone photography to evaluate patients with actinic keratoses on topical 5-FU treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Actinic Keratosis
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Feedback group (teledermatology)
Arm Type
Experimental
Arm Title
Control group (phone only)
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
teledermatology feedback
Intervention Description
subject provided feedback to continue or discontinue their cream (based on actinic keratoses grading and lesion counting)
Primary Outcome Measure Information:
Title
Difference in total dose of exposure to 5-FU between teledermatology and control group (measured as days of exposure x frequency of application per day)
Description
The total exposure to 5-FU will be calculated as total doses over 4 week period.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Patient satisfaction assessment
Time Frame
4 weeks and 8 weeks
Title
Change in clinical grading of actinic keratoses
Time Frame
baseline and weeks 1, 2, 3, 4, 8
Title
Change in AK lesion count
Time Frame
baseline and weeks 1, 2, 3, 4, 8
Title
Change in severity of symptoms
Time Frame
baseline and weeks 1, 2, 3, 4, 8
Title
Difference in adverse effects including erythema, pruritus, burning, soreness, and/or tenderness, crusting and/or erosions, scaling and/or flaking, and swelling
Time Frame
baseline and weeks 1, 2, 3, 4, 8
Title
Difference in number of clinic visits between the 2 groups
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects 18 years of age or older
Subjects who have already been prescribed topical 5-fluorouracil for treatment of scalp, facial, arm, or hand actinic keratoses but have not initiated treatment yet
Exclusion Criteria:
Adults unable to consent
Non English speaking or illiterate
Subjects with known allergy to 5-fluorouracil
Subjects who do not have access to a smartphone capable of engaging with the online teledermatology platform
Pregnant women
Prisoners
Facility Information:
Facility Name
UC Davis Department of Dermatology
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
24138974
Citation
Zuo KJ, Guo D, Rao J. Mobile teledermatology: a promising future in clinical practice. J Cutan Med Surg. 2013 Nov-Dec;17(6):387-91. doi: 10.2310/7750.2013.13030.
Results Reference
background
PubMed Identifier
24522259
Citation
Fox LP. Practice Gaps. Improving accessibility to inpatient dermatology through teledermatology. JAMA Dermatol. 2014 Apr;150(4):424-5. doi: 10.1001/jamadermatol.2013.9516. No abstract available.
Results Reference
background
PubMed Identifier
24067948
Citation
Brewer AC, Endly DC, Henley J, Amir M, Sampson BP, Moreau JF, Dellavalle RP. Mobile applications in dermatology. JAMA Dermatol. 2013 Nov;149(11):1300-4. doi: 10.1001/jamadermatol.2013.5517.
Results Reference
background
PubMed Identifier
25865875
Citation
Stockfleth E, Peris K, Guillen C, Cerio R, Basset-Seguin N, Foley P, Sanches J, Culshaw A, Erntoft S, Lebwohl M. A consensus approach to improving patient adherence and persistence with topical treatment for actinic keratosis. Int J Dermatol. 2015;54(5):509-15. doi: 10.1111/ijd.12840. Epub 2015 Apr 10.
Results Reference
background
PubMed Identifier
25950503
Citation
Pomerantz H, Hogan D, Eilers D, Swetter SM, Chen SC, Jacob SE, Warshaw EM, Stricklin G, Dellavalle RP, Sidhu-Malik N, Konnikov N, Werth VP, Keri J, Lew R, Weinstock MA; Veterans Affairs Keratinocyte Carcinoma Chemoprevention (VAKCC) Trial Group. Long-term Efficacy of Topical Fluorouracil Cream, 5%, for Treating Actinic Keratosis: A Randomized Clinical Trial. JAMA Dermatol. 2015 Sep;151(9):952-60. doi: 10.1001/jamadermatol.2015.0502.
Results Reference
background
PubMed Identifier
23215635
Citation
Esmann S, Jemec GB. Patients' perceptions of topical treatments of actinic keratosis. J Dermatolog Treat. 2014 Oct;25(5):375-9. doi: 10.3109/09546634.2012.757285. Epub 2013 Feb 24.
Results Reference
background
Learn more about this trial
Pilot Study of the Pragmatic Use of Mobile Phone Based Follow up of Actinic Keratoses Treated With Topical 5-fluorouracil
We'll reach out to this number within 24 hrs