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

NCT ID: NCT04850781

Last Updated: 2024-01-03

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

243 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-12

Study Completion Date

2022-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Dementia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a Phase 1 pilot feasibility study that uses an embedded, pragmatic randomized clinical trial design.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Daily Meals

A lunch-time meal delivered to participants' homes multiple times per week with wellness check and socialization.

Group Type ACTIVE_COMPARATOR

Daily home meal delivery

Intervention Type 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.

Frozen, Drop-shipped Meals

10 frozen meals that are mailed to participants every two weeks.

Group Type EXPERIMENTAL

Bi-weekly frozen meal home delivery

Intervention Type 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.

Interventions

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Bi-weekly frozen meal home delivery

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.

Intervention Type BEHAVIORAL

Daily home meal delivery

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

66 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

Meals on Wheels America

OTHER

Sponsor Role collaborator

Brown University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kali S Thomas, PhD

Role: PRINCIPAL_INVESTIGATOR

Brown University, School of Public Health

Locations

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Neighborly Senior Services

Clearwater, Florida, United States

Site Status

Visiting Nurse Association of Texas

Dallas, Texas, United States

Site Status

Meals on Wheels - San Antonio

San Antonio, Texas, United States

Site Status

Countries

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United States

References

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Bunker JN, Hilgeman MM, McCreedy E, Gadbois E, Thomas KS. Evaluating the Implementation Fidelity of a Pilot Pragmatic Randomized Clinical Trial Comparing Daily-Delivered Meals to Mailed Frozen Meals. J Appl Gerontol. 2024 Nov;43(11):1605-1610. doi: 10.1177/07334648241248269. Epub 2024 Apr 30.

Reference Type DERIVED
PMID: 38686741 (View on PubMed)

Thomas KS, Bunker J, Gadbois E, Hilgeman M, McCreedy E, Mills W, Ornstein KA, Reckrey J, Gutman R. Home-Delivered Meals and Nursing Home Placement Among People With Self-Reported Dementia: A Pilot Pragmatic Clinical Trial. JAMA Netw Open. 2023 Dec 1;6(12):e2347195. doi: 10.1001/jamanetworkopen.2023.47195.

Reference Type DERIVED
PMID: 38117500 (View on PubMed)

Gadbois EA, Bunker JN, Hilgeman M, Shield R, McAuliff KE, Mills W, Thomas K. Feasibility of conducting qualitative research with persons living with dementia and their caregivers during a home-delivered meals pilot trial. Pilot Feasibility Stud. 2023 Apr 22;9(1):65. doi: 10.1186/s40814-023-01302-5.

Reference Type DERIVED
PMID: 37085899 (View on PubMed)

Provided Documents

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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Related Links

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https://pilotfeasibilitystudies.biomedcentral.com/articles/10.1186/s40814-023-01302-5

Peer-reviewed paper describing the results from the qualitative sub-study

Other Identifiers

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R61AG070170

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2008002788

Identifier Type: -

Identifier Source: org_study_id

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