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临床试验/NCT04850781
NCT04850781已完成不适用

Home-delivered Meals for Persons With Dementia: Which Model Delays Nursing Home Placement?

Brown University6 个研究点 分布在 1 个国家目标入组 243 人开始时间: 2021年4月12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
243
试验地点
6
主要终点
Time to Nursing Home Placement

研究概览

简要总结

This project is the pilot phase of a pragmatic randomized clinical trial comparing outcomes among older adults with Alzheimer's disease and related dementias (ADRD) receiving home-delivered meals. This pilot will test and validate vital elements and procedures including: 1) enrolling persons with ADRD on Meals on Wheels (MOW) programs' waiting lists to receive one of the two types of meals; 2) recruiting a subsample of participants and caregivers to participate in telephone interviews; 3) extracting and transferring program data to Brown University; 4) linking participant data with Medicare and nursing home assessment data. Persons with ADRD receiving meals and their caregivers will be recruited to pilot interview guides. The interviews will provide important process and mechanistic information about the experiences receiving meals and participants' outcomes.

详细描述

236 individuals on the waiting list at three MOW programs (Neighborly Senior Services in Clearwater, Florida; Visiting Nurse Association of Texas in Dallas, Texas; Meals on Wheels - San Antonio in San Antonio, Texas) will be randomized to one of the following modes of delivery: 1) meals that are delivered multiple times per week by a MOW program volunteer or paid driver and includes socialization and a wellness check or 2) frozen meals that are mailed to participants' homes every two weeks. Persons with ADRD receiving meals and their caregivers will be recruited to pilot interview guides.

The primary aim is to test and validate procedures to recruit participants with ADRD and evaluate their outcomes in partnership with MOW programs. The study also aims to characterize differences in the processes and potential mechanisms contributing to outcomes between the two modes of meal delivery among older adults with ADRD. The qualitative interviews with participants and their caregivers will provide important process and mechanistic information about the experiences receiving meals and participants' outcomes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • On MOW program waiting list
  • 66 years of age or older (to allow for Medicare enrollment and a one-year baseline look-back)
  • Self-reporting a diagnosis of memory loss, dementia, cognitive impairment, or Alzheimer's disease

排除标准

  • Residing in a service area where it is not possible to receive the daily-delivered meals.

结局指标

主要结局

Time to Nursing Home Placement

时间窗: 6 months / 180 days

We report the restricted mean survival time, which is the average time free from an event (i.e., nursing home placement) up until 180 days or death, whichever comes first.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (6)

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