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

Study Overview
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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.

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

Conditions
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Dementia

Intervention / Treatment
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* Behavioral: Bi-weekly frozen meal home delivery
* Behavioral: Daily home meal delivery


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 66 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a Phase 1 pilot feasibility study that uses an embedded, pragmatic randomized clinical trial design.
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Nursing Home Placement | We are measuring if the type of meal delivery (i.e., frozen vs. daily delivered meals) delays the time to nursing home placement. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nutrition, Homebound, Food insecurity