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

Dementia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04850781
• Other study ID #: 2008002788
• Secondary ID: R61AG070170
• Status: Completed
• Phase: N/A
• Start date: April 12, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: December 2023
• Source: Brown University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 243
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 66 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dementia

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Neighborly Senior Services	Clearwater	Florida
United States	Visiting Nurse Association of Texas	Dallas	Texas
United States	Meals on Wheels - San Antonio	San Antonio	Texas

Sponsors (3)

Lead Sponsor	Collaborator
Brown University	Meals on Wheels America, National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

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