An interventional study of Bi-weekly frozen meal home delivery and Daily home meal delivery in Dementia, sponsored by Brown University. Completed at 3 sites in United States. Open to participants aged 66 Years and older. Per ClinicalTrials.gov, last updated 2024-01-03.
Sponsored by Brown University · Not applicable, Interventional, and Supportive care
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.
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.
2,172 studies on the registry are indexed under Dementia; 541 are open to participants now.
This study's enrollment of 243 is above the median of 83 across 1,629 interventional studies indexed under Dementia.
Browse Dementia studies →Brown University is the lead sponsor of 282 studies on the registry; 42 are open to participants now.
Of its 25 completed or terminated interventional studies of FDA-regulated products, 18 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
A lunch-time meal delivered to participants' homes multiple times per week with wellness check and socialization.
Behavioral: Daily home meal delivery
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.
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.
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.
Time frame: 6 months / 180 days
Participants at 3 home-delivered meals sites were identified based on 1) being on a waitlist 2) self-identifying as having dementia and 3) being age 66 years and older. Randomization and enrollment began in April 2021 and continued until September 2021
| Milestone | Daily Meals | Frozen, Drop-shipped Meals |
|---|---|---|
| Started | 128 | 115 |
| Completed | 128 | 115 |
| Not completed | 0 | 0 |
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.
| Days | Daily Meals | Frozen, Drop-shipped Meals |
|---|---|---|
| Time to Nursing Home Placement | 172.0725 (168.8933 to 175.2517) | 165.0270 (161.1035 to 168.9505) |
Collected over 6 months from randomization/. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Daily Meals | 5/128 (3.9%) | 0/128 (0%) | 0/128 (0%) |
| Frozen, Drop-shipped Meals | 8/115 (7%) | 0/115 (0%) | 0/115 (0%) |
This was an intent-to-treat design; meaning, all participants who were enrolled were analyzed, regardless of how long they received meals.
| Age, Categorical(Participants) | Daily Meals | Frozen, Drop-shipped Meals | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 128 | 115 | 243 |
| Sex: Female, Male(Participants) | Daily Meals | Frozen, Drop-shipped Meals | Total |
|---|---|---|---|
| Female | 74 | 78 | 152 |
| Male | 54 | 37 | 91 |
| Race/Ethnicity, Customized(Participants) | Daily Meals | Frozen, Drop-shipped Meals | Total |
|---|---|---|---|
| Black | 21 | 22 | 43 |
| White | 64 | 64 | 128 |
| Hispanic | 37 | 25 | 62 |
| Other | 6 | 4 | 10 |
| Lives Alone(Participants) | Daily Meals | Frozen, Drop-shipped Meals | Total |
|---|---|---|---|
| Count of participants | 53 | 66 | 119 |
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Plan to share: No
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