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

Skin Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00535769
• Other study ID #: 2007-P-001456
• Status: Completed
• Phase: Phase 0
• First received: September 24, 2007
• Last updated: July 18, 2012
• Start date: September 2007
• Est. completion date: November 2007

Study information

• Verified date: July 2012
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: November 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)

Related Conditions & MeSH terms

• Skin Cancer

Intervention

Device:
• Electronic + no text message
Electronic monitor is attached but no text-messages are sent through cellular phones
• Electronic monitor + text messages
Electronic monitor is attached and text messages are sent through cellphone to remind sunscreen use

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	6 weeks	No
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)	6 weeks	No
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)	6 weeks	No