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Trial record 1 of 4 for:    19917951 [PUBMED-IDS]
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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor)
Condition Skin Cancer
Interventions Device: Electronic + no text message
Device: Electronic monitor + text messages
Enrollment 70
Recruitment Details participants must be >18 yo, own a cellular telephone with text-message features, and know how to retrieve text messages.
Pre-assignment Details  
Arm/Group Title Control: Electronic Monitor+ no Text Message Electronic Monitor + Text Message
Hide Arm/Group Description The control 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. The text message 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.
Period Title: Overall Study
Started 35 35
Completed 35 35
Not Completed 0 0
Arm/Group Title Control: Electronic Monitor+ no Text Message Electronic Monitor + Text Message Total
Hide Arm/Group Description The control 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. The text message 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. Total of all reporting groups
Overall Number of Baseline Participants 35 35 70
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 35 participants 35 participants 70 participants
34.3  (14.2) 32.9  (13.4) 33.6  (13.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 35 participants 70 participants
Female
25
  71.4%
24
  68.6%
49
  70.0%
Male
10
  28.6%
11
  31.4%
21
  30.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 35 participants 35 participants 70 participants
35 35 70
1.Primary Outcome
Title Number of Days the Subjects Are Adherent to Using Sunscreen
Hide Description 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.
Time Frame 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants were analyzed
Arm/Group Title Control: Electronic Monitor+ no Text Message Electronic Monitor + Text Message
Hide Arm/Group Description:
The control 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.
The text message 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.
Overall Number of Participants Analyzed 35 35
Mean (95% Confidence Interval)
Unit of Measure: days
12.6
(9.7 to 15.5)
23.6
(20.2 to 26.9)
2.Secondary Outcome
Title Usefulness of Text Messaging System
Hide Description 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)
Time Frame 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients with text messaging system included in analysis
Arm/Group Title Usefulness of Text Messaging System
Hide Arm/Group Description:
Patients with text reminder system were asked their opinion of the usefulness of message reminder from 0-10 (0, not useful at all; 10,most useful)
Overall Number of Participants Analyzed 35
Mean (Standard Deviation)
Unit of Measure: units on a scale
8.31  (1.99)
3.Secondary Outcome
Title Recalled Frequency of Sunscreen Application
Hide Description 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)
Time Frame 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants were assessed
Arm/Group Title Control: Electronic Monitor+ no Text Message Electronic Monitor + Text Message
Hide Arm/Group Description:
The control 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.
The text message 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.
Overall Number of Participants Analyzed 35 35
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.14  (1.17) 2.42  (0.95)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Control: Electronic Monitor+ no Text Message Electronic Monitor + Text Message
Hide Arm/Group Description The control 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. The text message 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.
All-Cause Mortality
Control: Electronic Monitor+ no Text Message Electronic Monitor + Text Message
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Control: Electronic Monitor+ no Text Message Electronic Monitor + Text Message
Affected / at Risk (%) Affected / at Risk (%)
Total   0/35 (0.00%)   0/35 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Control: Electronic Monitor+ no Text Message Electronic Monitor + Text Message
Affected / at Risk (%) Affected / at Risk (%)
Total   0/35 (0.00%)   0/35 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Alexa B. Kimball
Organization: MGH Curtis
Phone: 617-726-5066
Responsible Party: Alexandra Kimball, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00535769     History of Changes
Other Study ID Numbers: 2007-P-001456
First Submitted: September 24, 2007
First Posted: September 26, 2007
Results First Submitted: May 15, 2012
Results First Posted: July 18, 2012
Last Update Posted: July 20, 2012