Text Size

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

This study has been completed.
Sponsor:
Collaborator:
Brigham and Women's Hospital
Information provided by (Responsible Party):
Alexandra Kimball, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00535769
First received: September 24, 2007
Last updated: July 18, 2012
Last verified: July 2012
History of Changes
  Purpose

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.

Condition Intervention Phase
Skin Cancer
 Device: Electronic + no text message
Device: Electronic monitor + text messages
 Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Official Title: Evaluation of Adherence to Topical Agents: Applying Communication Technology to Improve Sunscreen Use

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Number of Days the Subjects Are Adherent to Using Sunscreen [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Usefulness of Text Messaging System [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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)

  • Recalled Frequency of Sunscreen Application [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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)


Enrollment: 70
Study Start Date: September 2007
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Electronic monitor with text message

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00535769

Locations
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Massachusetts General Hospital
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
  More Information

No publications provided

Responsible Party: Alexandra Kimball, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00535769     History of Changes
Other Study ID Numbers: 2007-P-001456
Study First Received: September 24, 2007
Results First Received: May 15, 2012
Last Updated: July 18, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
topical
medication adherence
adherence
compliance
 medication compliance
sunscreen
reminder

Additional relevant MeSH terms:
Skin Neoplasms
Neoplasms by Site
Neoplasms
Skin Diseases
Sunscreening Agents
Radiation-Protective Agents
 Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dermatologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013