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

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ClinicalTrials.gov Identifier: NCT00535769
Recruitment Status : Completed
First Posted : September 26, 2007
Results First Posted : July 18, 2012
Last Update Posted : July 20, 2012
Sponsor:
Collaborator:
Brigham and Women's Hospital
Information provided by (Responsible Party):
Alexandra Kimball, Massachusetts General Hospital

Tracking Information
First Submitted Date  ICMJE September 24, 2007
First Posted Date  ICMJE September 26, 2007
Results First Submitted Date  ICMJE May 15, 2012
Results First Posted Date  ICMJE July 18, 2012
Last Update Posted Date July 20, 2012
Study Start Date  ICMJE September 2007
Actual Primary Completion Date November 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 16, 2012)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 24, 2007)
  • Number of Days the Subjects Are Adherent to Using Sunscreen [ Time Frame: 6 weeks ]
  • Patient satisfaction with intervention [ Time Frame: 6 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 18, 2012)
  • 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)
  • 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)
Original Secondary Outcome Measures  ICMJE
 (submitted: September 24, 2007)
Reasons for poor adherence [ Time Frame: 6 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Adherence to Topical Agents: Applying Communication Technology to Improve Sunscreen Use
Official Title  ICMJE Evaluation of Adherence to Topical Agents: Applying Communication Technology to Improve Sunscreen Use
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 Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Condition  ICMJE Skin Cancer
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • 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.
    Intervention: Device: Electronic + no text message
  • 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.
    Intervention: Device: Electronic monitor + text messages
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 16, 2012)
70
Original Estimated Enrollment  ICMJE
 (submitted: September 24, 2007)
60
Actual Study Completion Date  ICMJE November 2007
Actual Primary Completion Date November 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00535769
Other Study ID Numbers  ICMJE 2007-P-001456
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Alexandra Kimball, Massachusetts General Hospital
Study Sponsor  ICMJE Massachusetts General Hospital
Collaborators  ICMJE Brigham and Women's Hospital
Investigators  ICMJE
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
PRS Account Massachusetts General Hospital
Verification Date July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP