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
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:
- To determine whether the use of electronic reminder system increases adherence to topical agents.
- To assess technological feasibility of measuring adherence to topical agents using electronic monitors specially designed for tubes.
- To assess technological feasibility of providing electronic reminders using cellular phone text-messaging system.
- To obtain subjects' feedback on the adherence monitoring and reminder system.
|Condition or disease||Intervention/treatment||Phase|
|Skin Cancer||Device: Electronic + no text message Device: Electronic monitor + text messages||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Evaluation of Adherence to Topical Agents: Applying Communication Technology to Improve Sunscreen Use|
|Study Start Date :||September 2007|
|Actual Primary Completion Date :||November 2007|
|Actual Study Completion Date :||November 2007|
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
- 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.
- 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00535769
|United States, Massachusetts|
|Brigham and Women's Hospital|
|Boston, Massachusetts, United States, 02115|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02115|
|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|