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临床试验/NCT05016141
NCT05016141已完成不适用

Health in Motion- A Digital Fall Prevention Program Designed to be Delivered in the Home

Blue Marble Rehab Inc2 个研究点 分布在 1 个国家目标入组 101 人开始时间: 2021年9月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
101
试验地点
2
主要终点
Rate of Falls per month

研究概览

简要总结

Falls among older adults are a serious public health concern and injuries resulting from falls can cause significant loss of independence, premature death, and higher caregiver burden. Home-based fall prevention programs, such as the Otago Exercise Program, educate older adults about the importance of identifying fall risk and provide strategies for reducing fall risk; however, many are costly and are not scalable, accessible, or sustainable. This project will evaluate the use of a digital solution that translates evidence-based fall prevention programs (such as Otago Exercise Program and Matter of Balance) to a digital solution (Health in Motion Fall Prevention Platform), as an alternative to home-based fall prevention programs that is affordable, scales to the millions of older adults across the country at risk for falls and is sustainable for the older adult's life.

详细描述

This study will involve 2 groups. Both groups will be followed for 12 months. The investigators will use a comparative prospective longitudinal (12-months) observational cohort study to compare the Health in Motion Fall Prevention Program with a no-intervention group. Metrics of effectiveness include the rate of falls, fall risk, fear of falling, and falls efficacy. Economic benefit will be measured using the EQ-5D-5L, along with hospital and clinical visits. The primary outcome is the incidence of falls (rate in person-months).

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

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

  • age of 55 and older
  • if history of 2 or more falls in the past year with a physician or physical therapist approval
  • Score >31 on the TICS (Telephone Interview for Cognitive Screen)
  • Easy for Me screen for inclusion

排除标准

  • any person who has been told by their physician that they should not exercise

研究组 & 干预措施

no intervention

No Intervention

Participants will be observed for 12 months. Participants will use the Health in Motion app to set goals and keep track of their health and health events, including falls. These participants will NOT receive the education modules or the exercise program.

digital fall prevention program

Experimental

Participants will complete the Health in Motion digital fall prevention program for 12 months. This program consists of education modules (modified from the Matter of Balance Program) and exercises based on a digital translation of the Otago Exercise Program.

干预措施: digital fall prevention program (Behavioral)

结局指标

主要结局

Rate of Falls per month

时间窗: Change from baseline fall rate at 12 months

Number of falls per month / number of participants x 1000

次要结局

  • Adherence to Education Modules(through study completion, an average of 1 year)
  • Activities Specific Balance Confidence Scale 5 Level(Change from baseline at 12 months)
  • Depression Screen(Change from baseline at 12 months)
  • Timed Up and Go Test(Change from baseline at 12 months)
  • 30 Second Sit to Stand Test(Change from baseline at 12 months)
  • One Leg Stand Test(Change from baseline at 12 months)
  • Education Modules Data (Intervention Group Only)(through study completion, an average of 1 year.)
  • VR-12(Change from baseline at 12 months)
  • Total number of repetitions of all exercises completed(through study completion, an average of 1 year)
  • 4 Stage Balance Test(Change from baseline at 12 months)
  • European Quality of Life 5-Dimensional Questionnaire (EQ-5D-5L)(Change from baseline at 12 months)
  • Trail Making Test - Digital(Change from baseline at 12 months)
  • Modified Fear of Falling Avoidance Behavior Questionnaire(Change from baseline at 12 months)
  • Fall Risk Questionnaire(Change from baseline at 12 months)
  • System Usability Scale(Change from baseline at 12 months)
  • Adherence to Exercise Program (Intervention Group Only)(through study completion, an average of 1 year)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (2)

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