Evaluation of Adherence to Topical Agents: Applying Communication Technology to Improve Sunscreen Use

Study Overview
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Brief Summary
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The purpose of this study is to determine if using an electronic reminder improves adherence to sunscreen use. The specific study aims are as follows: To determine whether the use of electronic reminder system increases adherence to topical agents. To assess technological feasibility of measuring adherence to topical agents using electronic monitors specially designed for tubes. To assess technological feasibility of providing electronic reminders using cellular phone text-messaging system. To obtain subjects' feedback on the adherence monitoring and reminder system.

Detailed Description
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We propose to use communication technology to develop a novel means of monitoring and improving adherence to topical agents. We will conduct a randomized, single-blinded, controlled trial to assess the impact of automated reminder system on adherence rates to sunscreens. This study will involve designing an electronic monitoring device specifically for topical agents and creating a platform for an automated reminder system. The electronic monitoring devices will be adaptable to tubes of varying shapes and sizes, and they will send SMS messages to a central server in real-time each time the tube is opened. We will create a text-message reminder system to send reminders to users' cellular phones over a secured network. Our hypothesis is that the electronic monitoring and reminder system will increase patients' adherence to topical agents. We will measure the impact of the intervention on adherence rates and assess patients' views on the reminder system. This project will allow us to engineer a novel device to electronically monitor adherence to topical agents and to use communication technology to change patients' behavior.

Official Title
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Evaluation of Adherence to Topical Agents: Applying Communication Technology to Improve Sunscreen Use

Conditions
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Skin Cancer

Intervention / Treatment
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* Device: Electronic + no text message
* Device: Electronic monitor + text messages


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age or older at time of consent, may be men or women. Capable of giving informed consent Have a cellular phone capable of receiving text messages. Able to adhere to the study visit schedule and other protocol requirements. Exclusion Criteria: Non-English speaking individuals

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Electronic monitor + no text message<br>The control or placebo comparator group of subjects will receive the study sunscreen with the attached electronic monitor. They will be instructed to apply sunscreen once a day in the morning to the sun-exposed areas of the body. If the subjects are to have continuous sun exposure (for example, at a beach), they are to re-apply the sunscreen every 3 hours. | Device: Electronic + no text message<br>* Electronic monitor is attached but no text-messages are sent through cellular phones<br>* Other names: Electronic monitor without text messages;|
| Experimental: Electronic monitor + Text message<br>The text message experimental group of subjects will receive the study sunscreen with the attached electronic monitor. In addition, this group will receive daily text messages on their cellular phone to remind them to apply the sunscreen. The text message will also contain the daily weather information. This group will also be instructed to apply sunscreen once a day in the morning to the sun-exposed areas of the body. If subjects are to have continuous sun exposure (for example, at a beach), they are to re-apply the sunscreen every 3 hours. | Device: Electronic monitor + text messages<br>* Electronic monitor is attached and text messages are sent through cellphone to remind sunscreen use<br>* Other names: Electronic monitor with text message;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Days the Subjects Are Adherent to Using Sunscreen | Participants' adherence was captured in real time using transmitting electronic monitors. At the end of the 6 week trial, the mean number of days the subjects are adherent to using sunscreen were compared. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Usefulness of Text Messaging System | Patients with the text message reminder system were asked their opinion on their satisfaction/ improved adherence to sunscreen application with the use of the messaging system on a scale of 0 to 10 (0, not useful at all; 10,most useful) | 6 weeks | 
| Recalled Frequency of Sunscreen Application | The participants were asked to recall their frequency of sunscreen application based on a 5 point scale (0 never used sunscreen,; 1 forgot to apply 3x weekly,; 2 forgot to apply 1-2x weekly; 3 forgot to apply 1-2x per month; 4 always remembered) | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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topical, medication adherence, adherence, compliance, medication compliance, sunscreen, reminder