Skin Cancer
Conditions
Keywords
topical, medication adherence, adherence, compliance, medication compliance, sunscreen, reminder
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.
Detailed description
We propose to use communication technology to develop a novel means of monitoring and improving adherence to topical agents. We will conduct a randomized, single-blinded, controlled trial to assess the impact of automated reminder system on adherence rates to sunscreens. This study will involve designing an electronic monitoring device specifically for topical agents and creating a platform for an automated reminder system. The electronic monitoring devices will be adaptable to tubes of varying shapes and sizes, and they will send SMS messages to a central server in real-time each time the tube is opened. We will create a text-message reminder system to send reminders to users' cellular phones over a secured network. Our hypothesis is that the electronic monitoring and reminder system will increase patients' adherence to topical agents. We will measure the impact of the intervention on adherence rates and assess patients' views on the reminder system. This project will allow us to engineer a novel device to electronically monitor adherence to topical agents and to use communication technology to change patients' behavior.
Interventions
DEVICEElectronic + no text message
Electronic monitor is attached but no text-messages are sent through cellular phones
DEVICEElectronic monitor + text messages
Electronic monitor is attached and text messages are sent through cellphone to remind sunscreen use
Sponsors
Brigham and Women's Hospital
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 18 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.
Exclusion criteria
* Non-English speaking individuals
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Days the Subjects Are Adherent to Using Sunscreen | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Usefulness of Text Messaging System | 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 | 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) |
Countries
United States
Participant flow
Recruitment details
participants must be \>18 yo, own a cellular telephone with text-message features, and know how to retrieve text messages.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 35 |
| 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. | 35 |
| Total | 70 |
Baseline characteristics
| Characteristic | Control: Electronic Monitor+ no Text Message | Electronic Monitor + Text Message | Total |
|---|---|---|---|
| Age Continuous | 34.3 years STANDARD_DEVIATION 14.2 | 32.9 years STANDARD_DEVIATION 13.4 | 33.6 years STANDARD_DEVIATION 13.8 |
| Region of Enrollment United States | 35 participants | 35 participants | 70 participants |
| Sex: Female, Male Female | 25 Participants | 24 Participants | 49 Participants |
| Sex: Female, Male Male | 10 Participants | 11 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 35 | 0 / 35 |
| serious Total, serious adverse events | 0 / 35 | 0 / 35 |
Outcome results
Primary
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.
Time frame: 6 weeks
Population: All participants were analyzed
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Control: Electronic Monitor+ no Text Message | Number of Days the Subjects Are Adherent to Using Sunscreen | 12.6 days |
| Electronic Monitor + Text Message | Number of Days the Subjects Are Adherent to Using Sunscreen | 23.6 days |
Secondary
Recalled Frequency of Sunscreen Application
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
Population: All participants were assessed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control: Electronic Monitor+ no Text Message | Recalled Frequency of Sunscreen Application | 2.14 units on a scale | Standard Deviation 1.17 |
| Electronic Monitor + Text Message | Recalled Frequency of Sunscreen Application | 2.42 units on a scale | Standard Deviation 0.95 |
Secondary
Usefulness of Text Messaging System
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
Population: Patients with text messaging system included in analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control: Electronic Monitor+ no Text Message | Usefulness of Text Messaging System | 8.31 units on a scale | Standard Deviation 1.99 |