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Clinical Trials/NCT00535769
NCT00535769CompletedEarly Phase 1

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

Massachusetts General Hospital4 sites in 1 country70 target enrollmentStarted: September 2007Last updated:
Conditions

Trial Snapshot

Phase
Early Phase 1
Status
Completed
Enrollment
70
Locations
4
Primary Endpoint
Number of Days the Subjects Are Adherent to Using Sunscreen

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

Number of Days the Subjects Are Adherent to Using Sunscreen

Time Frame: 6 weeks

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.

Secondary Outcomes

  • Usefulness of Text Messaging System(6 weeks)
  • Recalled Frequency of Sunscreen Application(6 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Alexandra Kimball

Principal Investigator

Massachusetts General Hospital

Study Sites (4)

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