Trial Outcomes & Findings for Evaluation of Adherence to Topical Agents: Applying Communication Technology to Improve Sunscreen Use (NCT NCT00535769)

NCT ID: NCT00535769

Last Updated: 2012-07-20

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: EARLY_PHASE1
• Target enrollment: 70 participants
• Primary outcome timeframe: 6 weeks
• Results posted on: 2012-07-20

Participant Flow

participants must be >18 yo, own a cellular telephone with text-message features, and know how to retrieve text messages.

Participant milestones

Measure	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.
Overall Study STARTED	35	35
Overall Study COMPLETED	35	35
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Control: Electronic Monitor+ no Text Message n=35 Participants 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 n=35 Participants 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 n=70 Participants Total of all reporting groups
Age Continuous	34.3 years STANDARD_DEVIATION 14.2 • n=5 Participants	32.9 years STANDARD_DEVIATION 13.4 • n=7 Participants	33.6 years STANDARD_DEVIATION 13.8 • n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	24 Participants n=7 Participants	49 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	11 Participants n=7 Participants	21 Participants n=5 Participants
Region of Enrollment United States	35 participants n=5 Participants	35 participants n=7 Participants	70 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 weeks

Population: All participants were analyzed

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.

Outcome measures

Measure	Control: Electronic Monitor+ no Text Message n=35 Participants 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 n=35 Participants 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.
Number of Days the Subjects Are Adherent to Using Sunscreen	12.6 days Interval 9.7 to 15.5	23.6 days Interval 20.2 to 26.9

SECONDARY outcome

Timeframe: 6 weeks

Population: Patients with text messaging system included in analysis

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)

Outcome measures

Measure	Control: Electronic Monitor+ no Text Message n=35 Participants 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.
Usefulness of Text Messaging System	8.31 units on a scale Standard Deviation 1.99	—

SECONDARY outcome

Timeframe: 6 weeks

Population: All participants were assessed

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)

Outcome measures

Measure	Control: Electronic Monitor+ no Text Message n=35 Participants 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 n=35 Participants 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.
Recalled Frequency of Sunscreen Application	2.14 units on a scale Standard Deviation 1.17	2.42 units on a scale Standard Deviation 0.95

Adverse Events

Control: Electronic Monitor+ no Text Message

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Electronic Monitor + Text Message

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Alexa B. Kimball

MGH Curtis

Phone: 617-726-5066

Email: harvardskinstudies@partners.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place