Evaluation of Adherence to Topical Agents: Applying Communication Technology to Improve Sunscreen Use - Full Text View

Sponsor:	Massachusetts General Hospital
Collaborator:	Brigham and Women's Hospital
Information provided by:	Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00535769

Purpose

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:

To determine whether the use of electronic reminder system increases adherence to topical agents.
To assess technological feasibility of measuring adherence to topical agents using electronic monitors specially designed for tubes.
To assess technological feasibility of providing electronic reminders using cellular phone text-messaging system.
To obtain subjects' feedback on the adherence monitoring and reminder system.

Condition	Intervention
Skin Cancer	Other: text-message reminders

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor)
Official Title:	Evaluation of Adherence to Topical Agents: Applying Communication Technology to Improve Sunscreen Use

Resource links provided by NLM:

MedlinePlus related topics: Cancer Skin Cancer Sun Exposure

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:

number of days the subjects are adherent to using sunscreen [ Time Frame: 6 weeks ]
Patient satisfaction with intervention [ Time Frame: 6 weeks ]

Secondary Outcome Measures:

Reasons for poor adherence [ Time Frame: 6 weeks ]

Estimated Enrollment:	60
Study Start Date:	September 2007
Estimated Study Completion Date:	November 2007

Arms	Assigned Interventions
No Intervention: 1 The first 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.
Experimental: 2 The second 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.	Other: text-message reminders We are using text-messages through cellular phones as intervention to remind subjects to use their sunscreen.

Arms

Assigned Interventions

No Intervention: 1

The first 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.

Experimental: 2

The second 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.

Other: text-message reminders

We are using text-messages through cellular phones as intervention to remind subjects to use their sunscreen.

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00535769

Locations

United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
Boston, Massachusetts, United States, 02115

Sponsors and Collaborators

Massachusetts General Hospital

Brigham and Women's Hospital

Investigators

Principal Investigator:	Alexa B Kimball, MD MPH	Brigham and Women's Hospital and Massachusetts General Hospital
Study Director:	April W Armstrong, MD	Brigham and Women's Hospital and Massachusetts General Hospital

More Information

No publications provided

Responsible Party:	Alexandra B. Kimball, Massachusetts General Hospital, Boston, MA 02114
ClinicalTrials.gov Identifier:	NCT00535769 History of Changes
Other Study ID Numbers:	2007-P-001456
Study First Received:	September 24, 2007
Last Updated:	May 19, 2008
Health Authority:	United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:

topical
medication adherence
adherence
compliance

medication compliance
sunscreen
reminder

Additional relevant MeSH terms:

Skin Neoplasms
Neoplasms by Site
Neoplasms
Skin Diseases
Sunscreening Agents
Radiation-Protective Agents

Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dermatologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 07, 2012