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临床试验/NCT01105104
NCT01105104Unknown1 期

An Enhanced Medication Monitoring Program

MedMinder Systems Inc.1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2011年9月最近更新:
适应症

试验速览

阶段
1 期
入组人数
150
试验地点
1
主要终点
medication adherence

研究概览

简要总结

The goal of the Enhanced Medication Management Program (eMMp) being developed by MedMinder Systems, Inc. is to increase the ability of frail elders to adhere to complex medication regimens for chronic conditions. Adherence will facilitate effective self-care and decrease personal and societal costs associated with disease progression and loss of independence. Multiple studies have shown that more frequent personal follow-up is the most effective way to maximize medication adherence, but such personal care is too costly to translate well to real life in a world of limited healthcare resources.

Currently available "smart pillboxes" are too expensive, too limited in the number and types of medications delivered, and too technically complex for the large majority of senior citizens. The eMMp is designed to deliver prompts and reminders to the user, to be remotely programmable by caregivers, to allow the option of using pre-filled medication trays, to provide electronic adherence reports to family/caregivers and to provide personalized reinforcing phone calls from professional caregivers, all at a modest cost. The in-home ReMinder will use a familiar pillbox layout (4 doses/day for 7 days) and allow easy removal of medication cups by elderly, rheumatic fingers. Installation will require only an electrical outlet (no modems or dedicated phone lines). Once plugged in, the built-in pager will continuously download remotely programmed visual and/or aural prompts and reminders from a central server (RemoteMind). It will continuously upload the date and time when each medi-cation cup is removed and when weekly refill is carried out, enabling remote adherence monitoring, alerts to caregivers, and follow-up intervention(s) from personal and/or professional caregivers as needed.

The hypothesis to be tested in this 2 year SBIR Phase I work plan is that the eMMp will significantly im-prove adherence and clinical outcome (blood pressure control) in a population of frail elderly who are hyper-tensive. SBIR Phase II will determine the minimum level of intervention needed to achieve sustained medication adherence and control of blood pressure in a larger group of hypertensive elders.

研究设计

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

入排标准

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

入选标准

  • persons aged 55 years and older who are coming in for routine outpatient visits
  • speaks and reads English
  • history of high blood pressure
  • systolic blood pressure ≥ 130 mm Hg
  • using antihypertensive medication
  • using 2 or more prescription medications
  • plans to stay in area for the 9 months of study
  • Exclusion criteria:
  • receives personal help or reminders to take medication
  • has moderate to severe dementia (MMSE score<18)
  • has severe hearing or vision deficiency

排除标准

  • 未提供

结局指标

主要结局

medication adherence

时间窗: 6 months

change in systolic blood pressure

时间窗: 6 months

次要结局

  • change in self-efficacy about taking medication(6 months)
  • self-reported medication taking(6 months)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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