Home-delivered Meals for Persons With Dementia: Which Model Delays Nursing Home Placement?
Primary Purpose
Dementia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bi-weekly frozen meal home delivery
Daily home meal delivery
Sponsored by
About this trial
This is an interventional supportive care trial for Dementia focused on measuring Nutrition, Homebound, Food insecurity
Eligibility Criteria
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.
Sites / Locations
- Neighborly Senior Services
- Visiting Nurse Association of Texas
- Meals on Wheels - San Antonio
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Daily Meals
Frozen, Drop-shipped Meals
Arm Description
A lunch-time meal delivered to participants' homes multiple times per week with wellness check and socialization.
10 frozen meals that are mailed to participants every two weeks.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04850781
First Posted
April 16, 2021
Last Updated
August 24, 2023
Sponsor
Brown University
Collaborators
National Institute on Aging (NIA), Meals on Wheels America
1. Study Identification
Unique Protocol Identification Number
NCT04850781
Brief Title
Home-delivered Meals for Persons With Dementia: Which Model Delays Nursing Home Placement?
Official Title
Home-delivered Meals for Persons With Dementia: Which Model Delays Nursing Home Placement?
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
April 12, 2021 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Brown University
Collaborators
National Institute on Aging (NIA), Meals on Wheels America
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia
Keywords
Nutrition, Homebound, Food insecurity
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is a Phase 1 pilot feasibility study that uses an embedded, pragmatic randomized clinical trial design.
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
243 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Daily Meals
Arm Type
Active Comparator
Arm Description
A lunch-time meal delivered to participants' homes multiple times per week with wellness check and socialization.
Arm Title
Frozen, Drop-shipped Meals
Arm Type
Experimental
Arm Description
10 frozen meals that are mailed to participants every two weeks.
Intervention Type
Behavioral
Intervention Name(s)
Bi-weekly frozen meal home delivery
Intervention Description
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
Intervention Name(s)
Daily home meal delivery
Intervention Description
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 Outcome Measure Information:
Title
Time to Nursing Home Placement
Description
We are measuring if the type of meal delivery (i.e., frozen vs. daily delivered meals) delays the time to nursing home placement.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
66 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kali S Thomas, PhD
Organizational Affiliation
Brown University, School of Public Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Neighborly Senior Services
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33762
Country
United States
Facility Name
Visiting Nurse Association of Texas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75247
Country
United States
Facility Name
Meals on Wheels - San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://pilotfeasibilitystudies.biomedcentral.com/articles/10.1186/s40814-023-01302-5
Description
Peer-reviewed paper describing the results from the qualitative sub-study
Learn more about this trial
Home-delivered Meals for Persons With Dementia: Which Model Delays Nursing Home Placement?
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