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临床试验/NCT03301116
NCT03301116已完成不适用

Promoting Seniors' Health With Home Care Aides: A Randomized Controlled Trial

University of Illinois at Chicago2 个研究点 分布在 1 个国家目标入组 157 人开始时间: 2017年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
157
试验地点
2
主要终点
Change from Baseline Function (Daily activity difficulties and dependency in older home care clients) at Month 4

研究概览

简要总结

This study aims to test whether a safe physical activity program with a built-in motivational enhancement component, performed in a seated position, preserves the function and well-being of older home care clients.

详细描述

Regular physical activity benefits older adults physically and mentally. However, the availability and the evidence for physical activity programs that are safe and appropriate for home-bound older adults at risk for nursing home admission are limited. The current project aims to examine the effectiveness of a safe physical activity program, led by home care aides who regularly help hard-to-reach older home care clients with housekeeping and routine personal care services in the home. The primary aim is to test whether the safe physical activity program with a built-in motivational enhancement component, performed in a seated position, preserves the function and well-being of home care clients. The secondary aim is to understand for whom the program is efficacious, the extent to which the program can reach the target population, the extent to which participants drop out of the program, the extent to which program participants maintain the behavioral change introduced by the intervention, and what the program's cost-effectiveness is. Building on a pilot project that demonstrated the program's feasibility in a large home care program funded by the state and Medicaid, this randomized controlled trial will inform future expansion of the physical activity program into real-world home care settings.

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)

盲法说明

N/A (there are no other parties who will be masked in the clinical trial)

入排标准

年龄范围
60 Years 至 110 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • English or Spanish-speaking older adults aged 60+
  • Receiving Illinois Department on Aging Community Care Program In-Home service from the collaborating home care agency
  • Able to sit in a chair independently for >=15 minutes (it is fine if the person needs help with transferring to a chair)
  • Cognitive status sufficient to follow directions and respond to survey questions as determined by the Six-Item Screener (Callahan, et al., 2002) (the instrument used in the phone screening) and the Modified Mini-Mental State (3MS) Examination (the instrument used in the in-home screening)
  • Willing to be assigned to either intervention program
  • Willing to have the research team notify the primary care physician of the client's study participation

排除标准

  • Having a legal guardian appointed
  • Bedridden or unable to sit in a chair independently
  • Receiving hospice care or having a terminal diagnosis
  • Self-reported inability to read large print books
  • HOME CARE AIDES
  • Inclusion Criteria:
  • English or Spanish-speaking home care aide caring for an older home care client eligible for the study
  • Age 18 and older
  • Willing to implement the intervention program routine with their eligible client(s) for the full 4 months
  • Willing to be randomly assigned to either intervention program
  • Intend to be a home care aide for the next 12 months
  • Exclusion Criteria
  • Not having a home care client who participates in the study

结局指标

主要结局

Change from Baseline Function (Daily activity difficulties and dependency in older home care clients) at Month 4

时间窗: Month 4

Activities of daily living that are specifically targeted by the intervention (6-items scale; each task will be scored 0-no difficulty/no help; 1=difficulty but no help; 2=need help; summed score, range 0-12)

次要结局

  • Short Physical Performance Battery (SPPB)(Baseline, Month 4, Month 8)
  • Exercise-related social support from home care aides(Baseline, Month 4, Month 8)
  • Self-rated health(Baseline, Month 4, Month 8)
  • Fear of falling(Baseline, Month 4, Month 8)

研究者

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

Naoko Muramatsu

Associate Professor

University of Illinois at Chicago

研究点 (2)

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