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临床试验/NCT00618800
NCT00618800已完成不适用

Preventing Falls Through Enhanced Pharmaceutical Care

University of North Carolina, Chapel Hill2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2004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
200
试验地点
2
主要终点
Time to first fall

研究概览

简要总结

The objective of the proposed study is to reduce the incidence of falls and fall-related injuries among community-dwelling older adults by better utilizing community pharmacists to advise patients and physicians on medication management.

详细描述

Falls are the leading cause of both fatal and nonfatal injuries among older adults in the United States. Past research suggests that individuals taking four or more prescription medications are at increased risk for falls. CNS-active drugs (e.g., benzodiazepines), in particular, have been associated with increased risk. Research also suggests that interventions to reduce inappropriate medications can reduce the risk of falls. This finding comes primarily from multifaceted interventions, however, and the impact of medication modification, by itself, remains largely unknown.

This study is using a a randomized controlled clinical trial design to evaluate a falls prevention program targeting community-dwelling older adults through community pharmacies. The study focuses on individuals at high risk for future falls. Individuals in the intervention group receive an in-depth consultation concerning their current medications, conducted by a community pharmacist. The consultation is designed to elicit medication-related problems (e.g., orthostatic hypotension, daytime sedation). Problems identified during the consultation, and therapeutic recommendations designed to address these problems, are communicated to the prescribing physician. With physician approval, appropriate modifications are made to the patient's medication regimen. The primary study endpoints are: time to first fall and proportion of individuals who fall during the one-year follow-up period.

Two primary hypotheses will be tested.

  1. Compared to individuals in the control group, individuals in the intervention group will experience a 30% reduction in the hazard of falling (hazard ratio=0.70) for time to first fall following randomization.
  2. Compared to individuals in the control group, 25% fewer people in the intervention group will experience a fall during the one-year follow-up period.

If the intervention is effective in reducing falls, these effects should be mediated by improvements in the overall quality of medication use. Thus, we will also assess effects of the intervention on: change in the number of inappropriate medications prescribed and change in the number of CNS-active medications prescribed.

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
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Currently taking at least four prescription medications
  • Currently taking at least one high risk medication
  • At least one fall during 12 month period before study entry
  • Able to speak and read English

排除标准

  • Resident of a long-term care facility
  • Cognitive impairment
  • Housebound

结局指标

主要结局

Time to first fall

时间窗: One Year

Proportion of participants who fall

时间窗: One Year

次要结局

  • Use of high-risk medications(One Year)

研究者

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

Susan Blalock, PhD

Associate Profesor

University of North Carolina, Chapel Hill

研究点 (2)

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