Clinical trial NCT00535769: Evaluation of Adherence to Topical Agents: Applying Communication Technology to Improve Sunscreen Use
Official title: Evaluation of Adherence to Topical Agents: Applying Communication Technology to Improve Sunscreen Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Skin Cancer
Keywords: topical
medication adherence
adherence
compliance
medication compliance
sunscreen
reminder
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Brigham and Women's Hospital
First posted: 2007-09-26
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Days the Subjects Are Adherent to Using Sunscreen
timeFrame: 6 weeks
Secondary outcomes:
measure: Usefulness of Text Messaging System
timeFrame: 6 weeks
measure: Recalled Frequency of Sunscreen Application
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital and Massachusetts General Hospital
name: Alexa B Kimball, MD MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Brigham and Women's Hospital and Massachusetts General Hospital
name: April W Armstrong, MD
role: STUDY_DIRECTOR
References:
citation: Armstrong AW, Watson AJ, Makredes M, Frangos JE, Kimball AB, Kvedar JC. Text-message reminders to improve sunscreen use: a randomized, controlled trial using electronic monitoring. Arch Dermatol. 2009 Nov;145(11):1230-6. doi: 10.1001/archdermatol.2009.269.