- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04850781
Home-delivered Meals for Persons With Dementia: Which Model Delays Nursing Home Placement?
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Florida
-
Clearwater, Florida, United States, 33762
- Neighborly Senior Services
-
-
Texas
-
Dallas, Texas, United States, 75247
- Visiting Nurse Association of Texas
-
San Antonio, Texas, United States, 78229
- Meals on Wheels - San Antonio
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Daily Meals
A lunch-time meal delivered to participants' homes multiple times per week with wellness check and socialization.
|
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.
|
|
Experimental: Frozen, Drop-shipped Meals
10 frozen meals that are mailed to participants every two weeks.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time to Nursing Home Placement
Time Frame: 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.
|
6 months / 180 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kali S Thomas, PhD, Brown University, School of Public Health
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2008002788
- R61AG070170 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.