Pilot Study of the Pragmatic Use of Mobile Phone Based Follow up of Actinic Keratoses Treated With Topical 5-fluorouracil
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- 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)
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Feedback group (teledermatology)
干预措施: teledermatology feedback (Other)
Control group (phone only)
结局指标
主要结局
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)
时间窗: 4 weeks
The total exposure to 5-FU will be calculated as total doses over 4 week period.
次要结局
- Patient satisfaction assessment(4 weeks and 8 weeks)
- Change in AK lesion count(baseline and weeks 1, 2, 3, 4, 8)
- Difference in adverse effects including erythema, pruritus, burning, soreness, and/or tenderness, crusting and/or erosions, scaling and/or flaking, and swelling(baseline and weeks 1, 2, 3, 4, 8)
- Change in clinical grading of actinic keratoses(baseline and weeks 1, 2, 3, 4, 8)
- Difference in number of clinic visits between the 2 groups(8 weeks)
- Change in severity of symptoms(baseline and weeks 1, 2, 3, 4, 8)