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临床试验/NCT00535769
NCT00535769已完成1 期

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

Massachusetts General Hospital2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2007年9月1日最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
已完成
入组人数
70
试验地点
2
主要终点
Number of Days the Subjects Are Adherent to Using Sunscreen

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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.

排除标准

  • •Non-English speaking individuals

研究组 & 干预措施

Electronic monitor + no text message

Placebo Comparator

The control or placebo comparator 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.

干预措施: Electronic + no text message (Device)

Electronic monitor + Text message

Experimental

The text message experimental 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.

干预措施: Electronic monitor + text messages (Device)

结局指标

主要结局

Number of Days the Subjects Are Adherent to Using Sunscreen

时间窗: 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.

次要结局

  • Usefulness of Text Messaging System(6 weeks)
  • Recalled Frequency of Sunscreen Application(6 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Alexandra Kimball

Principal Investigator

Massachusetts General Hospital

研究点 (2)

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