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

NCT04850781 | Completed Results

• 2 other identifiers: 2008002788R61AG070170
• Study Type: interventional
• Target: 243
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Dementia

Keywords

Nutrition; Homebound; Food insecurity

Outcome Measures

Primary Outcomes (1)

• Time to Nursing Home Placement

  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.

  6 months / 180 days

Study Arms (2)

Daily Meals

ACTIVE COMPARATOR

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

Behavioral: Daily home meal delivery

Frozen, Drop-shipped Meals

EXPERIMENTAL

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

Behavioral: Bi-weekly frozen meal home delivery

Interventions

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.

Frozen, Drop-shipped Meals

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.

Daily Meals

Eligibility Criteria

• Age: 66 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• On MOW program waiting list
• 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

You may not qualify if:

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

Sponsors & Collaborators

• Brown University: lead
• National Institute on Aging (NIA): collaborator
• Meals on Wheels America: collaborator

Study Sites (3)

Neighborly Senior Services

Clearwater, Florida, 33762, United States

Location

Visiting Nurse Association of Texas

Dallas, Texas, 75247, United States

Location

Meals on Wheels - San Antonio

San Antonio, Texas, 78229, United States

Location

Related Publications (3)

• 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.

  PMID: 38686741 DERIVED

• 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.

  PMID: 38117500 DERIVED

• 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.

  PMID: 37085899 DERIVED

Related Links

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

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Kali Thomas
• Organization: Johns Hopkins University

kali.thomas@jhu.edu

(410) 955-4766

Study Officials

• Kali S Thomas, PhD

  Brown University, School of Public Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a Phase 1 pilot feasibility study that uses an embedded, pragmatic randomized clinical trial design.

Study Record Dates

• First Submitted: April 16, 2021
• First Posted: April 20, 2021
• Study Start: April 12, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: January 3, 2024
• Results First Posted: January 3, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)