Dementia
Conditions
Keywords
Nutrition, Homebound, Food insecurity
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.
Interventions
BEHAVIORALBi-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.
BEHAVIORALDaily 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.
Sponsors
National Institute on Aging (NIA)
Meals on Wheels America
Brown University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)
Intervention model description
This is a Phase 1 pilot feasibility study that uses an embedded, pragmatic randomized clinical trial design.
Eligibility
Sex/Gender
ALL
Age
66 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Nursing Home Placement | 6 months / 180 days | 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. |
Countries
United States
Participant flow
Recruitment details
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
Pre-assignment details
243 participants were enrolled in the trial.
Participants by arm
| Arm | Count |
|---|---|
| Daily Meals A lunch-time meal delivered to participants' homes multiple times per week with wellness check and socialization.
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. | 128 |
| Frozen, Drop-shipped Meals 10 frozen meals that are mailed to participants every two weeks.
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. | 115 |
| Total | 243 |
Baseline characteristics
| Characteristic | Daily Meals | Frozen, Drop-shipped Meals | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 128 Participants | 115 Participants | 243 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Lives Alone | 53 Participants | 66 Participants | 119 Participants |
| Race/Ethnicity, Customized Black | 21 Participants | 22 Participants | 43 Participants |
| Race/Ethnicity, Customized Hispanic | 37 Participants | 25 Participants | 62 Participants |
| Race/Ethnicity, Customized Other | 6 Participants | 4 Participants | 10 Participants |
| Race/Ethnicity, Customized White | 64 Participants | 64 Participants | 128 Participants |
| Sex: Female, Male Female | 74 Participants | 78 Participants | 152 Participants |
| Sex: Female, Male Male | 54 Participants | 37 Participants | 91 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 5 / 128 | 8 / 115 |
| other Total, other adverse events | 0 / 128 | 0 / 115 |
| serious Total, serious adverse events | 0 / 128 | 0 / 115 |
Outcome results
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.
Time frame: 6 months / 180 days
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Daily Meals | Time to Nursing Home Placement | 172.0725 Days |
| Frozen, Drop-shipped Meals | Time to Nursing Home Placement | 165.0270 Days |