Randomized Trial of a Multifactorial Fall Injury Prevention Strategy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 5,451
- 试验地点
- 10
- 主要终点
- First Adjudicated Serious Fall-Related Injury
研究概览
简要总结
The aim of this pragmatic cluster-randomized trial is to determine the effectiveness of an evidence-based, patient-centered multifactorial fall injury prevention strategy in community dwelling older adults at risk of falls recruited from 86 primary care practices around the U.S.
详细描述
Objective: To determine the effectiveness of an evidence-based, patient-centered multifactorial fall injury prevention strategy implemented within primary care practices using usual health care resources
Design: This study is a cluster randomized, parallel group superiority trial with practices stratified by healthcare system and patients nested within practices. The unit of randomization is the practice.
Study Duration: The total study duration is 5 years. Recruitment will take place over 20 months, with follow-up taking place for 24 months - 44 months depending on date of enrollment.
Trial Sites: 86 primary care practices that are part of 10 trial sites located around the U.S.: The Partners' Health Care System; Essentia; Hopkins Health Care System; HealthCare Partners; Reliant Health Care System; Mount Sinai Health Care System; University of Pittsburgh Health Care System; University of Texas Medical Branch Health Care System; University of Iowa Health Care System; University of Michigan Health Care System.
Number of Subjects: The original target sample size was 6,000 participants enrolled in 86 practices to provide 90% power to detect a 20% reduction in the rate of the primary outcome with intervention relative to control. The study was originally designed for a study duration of 36 months with 18 months of recruitment and a minimum of 18 months of follow-up. The study was extended to a 44 month study (20 months of recruitment and a minimum 24 month of follow-up). For a 44 month trial, it was estimated that a sample size of 5,322 subjects would provide 90% power to detect a 20% reduction in the rate of the primary outcome with the intervention relative to control.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient is at least 70 years of age.
- •The patient must answer 'yes' to one or more of the following questions:
- •Have you fallen and hurt yourself in the past year?
- •Have you fallen 2 or more times in the past year?
- •Are you afraid that you might fall because of balance or walking problems?
排除标准
- •The patient is enrolled in hospice.
- •The patient resides in a nursing home.
- •The patient is not capable of providing informed consent (or assent), and a proxy is not available.
- •The patient does not speak English or Spanish
结局指标
主要结局
First Adjudicated Serious Fall-Related Injury
时间窗: Enrollment through last completed follow-up or death interview (max 44 months)
Number of first adjudicated serious fall-related injury serious fall-related injury events per 100 per years of follow-up.
次要结局
- First Self-reported Fall-related Injury(Enrollment through last completed follow-up or death interview (max 44 months))
- Depression(Measured at 12-month and 24-month follow-up assessments, reported score is an average (mean) of the follow-up scores.)
- Anxiety(Measured at 12-month and 24-month follow-up assessments, reported score is an average (mean) of the follow-up scores.)
- Fear of Falling(Measured at 12-month and 24-month follow-up assessments, reported score is an average (mean) of the follow-up scores.)
- Disability(measured at 12-month and 24-month follow-up assessments, reported score is an average (mean) of the follow-up scores)
- Time to Self-reported Falls(these data were not collected)
- Physical Function(measured at 12-month and 24-month follow-up assessments, reported score is an average (mean) of the follow-up scores)
研究者
Nancy Latham
Study Director
Brigham and Women's Hospital