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

Mass General Brigham

Status and phase: Completed; Early Phase 1

Conditions: Skin Cancer

Treatments: Device: Electronic + no text message; Device: Electronic monitor + text messages

Study type: Interventional

Funder types: Other

Identifiers

NCT00535769

2007-P-001456

Details and patient eligibility

About

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:

1. To determine whether the use of electronic reminder system increases adherence to topical agents.
2. To assess technological feasibility of measuring adherence to topical agents using electronic monitors specially designed for tubes.
3. To assess technological feasibility of providing electronic reminders using cellular phone text-messaging system.
4. To obtain subjects' feedback on the adherence monitoring and reminder system.

Full description

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.

Enrollment: 70 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

70 participants in 2 patient groups, including a placebo group

Electronic monitor + no text message

Placebo Comparator group

Description:

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.

Treatment:

Device: Electronic + no text message

Electronic monitor + Text message

Experimental group

Description:

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.

Treatment:

Device: Electronic monitor + text messages