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

• Sponsor: Brown University (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04850781
• Collaborator: National Institute on Aging (NIA) (NIH), Meals on Wheels America (Other)
• Enrollment: 243
• Locations: 3
• Arms: 2
• Anticipated Duration (Months): 17.6
• Patients Per Site: 81
• Patients Per Site Per Month: 4.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dementia	Behavioral: Bi-weekly frozen meal home delivery; Behavioral: Daily home meal delivery	N/A

Detailed Description

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 243 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: This is a Phase 1 pilot feasibility study that uses an embedded, pragmatic randomized clinical trial design.This is a Phase 1 pilot feasibility study that uses an embedded, pragmatic randomized clinical trial design.
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: Home-delivered Meals for Persons With Dementia: Which Model Delays Nursing Home Placement?
• Actual Study Start Date: Apr 12, 2021
• Actual Primary Completion Date: Apr 16, 2022
• Anticipated Study Completion Date: Sep 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Daily Meals A lunch-time meal delivered to participants' homes multiple times per week with wellness check and socialization.	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.
Experimental: Frozen, Drop-shipped Meals 10 frozen meals that are mailed to participants every two weeks.	Behavioral: 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.

Outcome Measures

Primary Outcome Measures

1. Time to Nursing Home Placement [6 months]

   We are measuring if the type of meal delivery (i.e., frozen vs. daily delivered meals) delays the time to nursing home placement.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 66 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Neighborly Senior Services	Clearwater	Florida	United States	33762
2	Visiting Nurse Association of Texas	Dallas	Texas	United States	75247
3	Meals on Wheels - San Antonio	San Antonio	Texas	United States	78229

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Kali S Thomas, PhD, Brown University, School of Public Health

Study Documents (Full-Text)

• Informed Consent Form - Feb 18, 2021

More Information

Publications

None provided.

• Responsible Party: Brown University
• ClinicalTrials.gov Identifier: NCT04850781
• Other Study ID Numbers: 2008002788; R61AG070170
• First Posted: Apr 20, 2021
• Last Update Posted: Jul 28, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Brown University: Nutrition; Homebound; Food insecurity
• Additional relevant MeSH terms: Dementia

Study Results

No Results Posted as of Jul 28, 2022