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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00535769
Other study ID # 2007-P-001456
Secondary ID
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


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
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