Evaluation of Adherence to Topical Agents: Applying Communication Technology to Improve Sunscreen Use
1 other identifier
interventional
70
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for early_phase_1
Started Sep 2007
Shorter than P25 for early_phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2007
CompletedFirst Submitted
Initial submission to the registry
September 24, 2007
CompletedFirst Posted
Study publicly available on registry
September 26, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2007
CompletedResults Posted
Study results publicly available
July 18, 2012
CompletedJuly 20, 2012
July 1, 2012
2 months
September 24, 2007
May 15, 2012
July 18, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Days the Subjects Are Adherent to Using Sunscreen
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 Outcomes (2)
Usefulness of Text Messaging System
6 weeks
Recalled Frequency of Sunscreen Application
6 weeks
Study Arms (2)
Electronic monitor + no text message
PLACEBO COMPARATORThe 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.
Electronic monitor + Text message
EXPERIMENTALThe 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.
Interventions
Electronic monitor is attached but no text-messages are sent through cellular phones
Electronic monitor is attached and text messages are sent through cellphone to remind sunscreen use
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Non-English speaking individuals
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Massachusetts General Hospitallead
- Brigham and Women's Hospitalcollaborator
Study Sites (2)
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Massachusetts General Hospital
Boston, Massachusetts, 02115, United States
Related Publications (1)
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.
PMID: 19917951DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Alexa B. Kimball
- Organization
- MGH Curtis
Study Officials
- 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
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 24, 2007
First Posted
September 26, 2007
Study Start
September 1, 2007
Primary Completion
November 1, 2007
Study Completion
November 1, 2007
Last Updated
July 20, 2012
Results First Posted
July 18, 2012
Record last verified: 2012-07