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

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.

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Key information

Conditions

Dementia Brain Diseases Central Nervous System Diseases Mental Disorders Nervous System Diseases Neurocognitive Disorders

Age range

66 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Neighborly Senior Services, Clearwater, Florida, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Bi-weekly frozen meal home delivery

Behavioral

All participants randomized to this arm will receive 10 frozen meals that are mailed to their home every two weeks from a MOW vendor, TRIO foods.

Daily home meal delivery

Behavioral

All participants randomized to this arm will receive meals delivered to their home multiple times per week from a MOW program employee/volunteer with a wellness check and socialization.

Primary outcomes

Time to Nursing Home Placement

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Brown University

Other

Collaborators

Meals on Wheels America
National Institute on Aging (NIA)

Registry information

Important dates

Study start: 2021
Primary completion: 2022
Study completion: 2022
First posted: Apr 20, 2021
Registry last updated: Jan 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed