Clinical trial NCT04850781: 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
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Keywords: Nutrition
Homebound
Food insecurity
Lead sponsor: Brown University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
name: Meals on Wheels America
First posted: 2021-04-20
Enrollment: 243
Sex: ALL
Minimum age (years): 66
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a Phase 1 pilot feasibility study that uses an embedded, pragmatic randomized clinical trial design.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Time to Nursing Home Placement
timeFrame: 6 months / 180 days
Secondary outcomes:
Other outcomes:
Locations:
city: Clearwater
country: United States
facility: Neighborly Senior Services
state: Florida
city: Dallas
country: United States
facility: Visiting Nurse Association of Texas
state: Texas
city: San Antonio
country: United States
facility: Meals on Wheels - San Antonio
state: Texas
Study officials:
affiliation: Brown University, School of Public Health
name: Kali S Thomas, PhD
role: PRINCIPAL_INVESTIGATOR
References: