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临床试验/NCT00985452
NCT00985452已完成不适用

The Impact of GlowCaps Connect™ and Its Services on Hypertension Medication Adherence: A Randomized Controlled Trial

Massachusetts General Hospital0 个研究点目标入组 139 人开始时间: 2009年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
139
主要终点
Quantify the impact of GlowCaps Connect™ and its services on hypertension medication adherence

研究概览

简要总结

The investigators hypothesize that providing subjects on a once-a-day hypertension medication with GlowCaps ConnectTM will lead to an improvement in their medication adherence. The investigators propose to conduct a 6-month randomized control trial to assess the effect of the GlowCaps Connect™ system on the enhancement of hypertension medication adherence among subjects with a diagnosis of hypertension recruited from the greater Boston area. 130 subjects will be enrolled. Subjects will be randomized into either the control group or into one of two intervention groups.

详细描述

Participants will use the GlowCap system for 6 months.

Group 1

  • The GlowCap bottle provided for subjects in this group will passively track medication adherence over the course of the study
  • The pill cap will collect data, but will not provide any visual or auditory alerts
  • An Ethernet Gateway connector will collect adherence data from the pill bottle cap via a local wireless network. This data will be sent out of subject's home through the internet.

Group 2

  • Subjects in this group will be given daily visual, auditory, and phone call reminders to take their medication via the GlowCap system if they fail to take their hypertension medication at the scheduled dose time
  • An Ethernet Gateway connector will collect adherence data from the pill bottle cap via a local wireless network. This data will be sent out of subject's home through the internet.
  • Subjects will receive Weekly and Monthly Progress Reports by email and mail, respectively. Reports will include information about medication adherence and target goals. If a subject does not opt-out, Monthly Progress Reports will also be sent to the subject's primary care physician (PCP)
  • If the subject chooses, a friend or family member will receive a Weekly Progress Report by email
  • If the subject chooses, he/she will receive prompts (via automated telephone call twice a month) to refill his/her prescription
  • Subjects demonstrating consistent low adherence to medication will receive additional support in the form of calls from Vitality reminding them to take the medication.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
盲法
None

入排标准

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

入选标准

  • Adult men and women age 18 and over
  • Diagnosis of hypertension
  • Take a once a day medication for hypertension
  • Internet access via broadband (not dial-up)
  • Home router
  • A private email account
  • Fluency in English (spoken and written)
  • Have a Primary Care Physician

排除标准

  • People will be excluded if they are not able to adequately respond to researcher's questions or complete the surveys.
  • People with significant cognitive deficits will be excluded.
  • People will be excluded if they take more than three medications a day for hypertension.
  • People will be excluded if they take more than five medications in one day.
  • People will be excluded if they have total color blindness.
  • People will be excluded if they are both blind and deaf.

结局指标

主要结局

Quantify the impact of GlowCaps Connect™ and its services on hypertension medication adherence

时间窗: 6 months

次要结局

  • Assess the usability and satisfaction of the GlowCap system(6 months)

研究者

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

Joseph C. Kvedar

Director, Center for Connected Health

Massachusetts General Hospital

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