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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
participants must be >18 yo, own a cellular telephone with text-message features, and know how to retrieve text messages.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Control: Electronic Monitor+ no Text Message 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.
Electronic Monitor + Text Message 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.

Participant Flow:   Overall Study
    Control: Electronic Monitor+ no Text Message   Electronic Monitor + Text Message
STARTED   35   35 
COMPLETED   35   35 
NOT COMPLETED   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Control: Electronic Monitor+ no Text Message 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.
Electronic Monitor + Text Message 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 Total of all reporting groups

Baseline Measures
   Control: Electronic Monitor+ no Text Message   Electronic Monitor + Text Message   Total 
Overall Participants Analyzed 
[Units: Participants]
 35   35   70 
Age 
[Units: Years]
Mean (Standard Deviation)
 34.3  (14.2)   32.9  (13.4)   33.6  (13.8) 
Gender 
[Units: Participants]
     
Female   25   24   49 
Male   10   11   21 
Region of Enrollment 
[Units: Participants]
     
United States   35   35   70 


  Outcome Measures

1.  Primary:   Number of Days the Subjects Are Adherent to Using Sunscreen   [ Time Frame: 6 weeks ]

2.  Secondary:   Usefulness of Text Messaging System   [ Time Frame: 6 weeks ]

3.  Secondary:   Recalled Frequency of Sunscreen Application   [ Time Frame: 6 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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
e-mail: harvardskinstudies@partners.org


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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