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Completed

NCT Number: NCT00535769

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Brigham and Women's Hospital, Boston, Massachusetts, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Electronic + no text message

Device

Electronic monitor is attached but no text-messages are sent through cellular phones

Other names: Electronic monitor without text messages

Electronic monitor + text messages

Device

Electronic monitor is attached and text messages are sent through cellphone to remind sunscreen use

Other names: Electronic monitor with text message

Primary outcomes

  1. 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

  1. 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)

  2. 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)

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Brigham and Women's Hospital

Registry information

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Sep 26, 2007
Registry last updated
Jul 20, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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