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

July 18, 2012 updated by: Alexandra Kimball, Massachusetts General Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

70

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital
      • Boston, Massachusetts, United States, 02115
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Electronic monitor + no text message
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
Electronic monitor is attached but no text-messages are sent through cellular phones
Other Names:
  • Electronic monitor without text messages
Experimental: Electronic monitor + Text message
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
Electronic monitor is attached and text messages are sent through cellphone to remind sunscreen use
Other Names:
  • Electronic monitor with text message

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Usefulness of Text Messaging System
Time Frame: 6 weeks
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
Time Frame: 6 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Collaborators

Brigham and Women's Hospital

Investigators

  • Principal Investigator: Alexa B Kimball, MD MPH, Brigham and Women's Hospital and Massachusetts General Hospital
  • Study Director: April W Armstrong, MD, Brigham and Women's Hospital and Massachusetts General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

November 1, 2007

Study Completion (Actual)

November 1, 2007

Study Registration Dates

First Submitted

September 24, 2007

First Submitted That Met QC Criteria

September 24, 2007

First Posted (Estimate)

September 26, 2007

Study Record Updates

Last Update Posted (Estimate)

July 20, 2012

Last Update Submitted That Met QC Criteria

July 18, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007-P-001456

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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