Trial Outcomes & Findings for Home-delivered Meals for Persons With Dementia: Which Model Delays Nursing Home Placement? (NCT NCT04850781)
NCT ID: NCT04850781
Last Updated: 2024-01-03
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
243 participants
Primary outcome timeframe
6 months / 180 days
Results posted on
2024-01-03
Participant Flow
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
243 participants were enrolled in the trial.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
128
|
115
|
|
Overall Study
COMPLETED
|
128
|
115
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Home-delivered Meals for Persons With Dementia: Which Model Delays Nursing Home Placement?
Baseline characteristics by cohort
| Measure |
Daily Meals
n=128 Participants
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.
|
Frozen, Drop-shipped Meals
n=115 Participants
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.
|
Total
n=243 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
128 Participants
n=5 Participants
|
115 Participants
n=7 Participants
|
243 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
74 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
152 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
54 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
91 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
21 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
64 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
128 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
37 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Lives Alone
|
53 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
119 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 months / 180 daysWe 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.
Outcome measures
| Measure |
Daily Meals
n=128 Participants
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.
|
Frozen, Drop-shipped Meals
n=115 Participants
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.
|
|---|---|---|
|
Time to Nursing Home Placement
|
172.0725 Days
Interval 168.8933 to 175.2517
|
165.0270 Days
Interval 161.1035 to 168.9505
|
Adverse Events
Daily Meals
Serious events: 0 serious events
Other events: 0 other events
Deaths: 5 deaths
Frozen, Drop-shipped Meals
Serious events: 0 serious events
Other events: 0 other events
Deaths: 8 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place