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| ID | Type | Description | Link |
|---|---|---|---|
| R61AG070170 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
| Meals on Wheels America | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Daily Meals | Active Comparator | A lunch-time meal delivered to participants' homes multiple times per week with wellness check and socialization. |
|
| Frozen, Drop-shipped Meals | Experimental | 10 frozen meals that are mailed to participants every two weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bi-weekly frozen meal home delivery | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months / 180 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kali S Thomas, PhD | Brown University, School of Public Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neighborly Senior Services | Clearwater | Florida | 33762 | United States | ||
| Visiting Nurse Association of Texas |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38686741 | Derived | Bunker JN, Hilgeman MM, McCreedy E, Gadbois E, Thomas KS. Evaluating the Implementation Fidelity of a Pilot Pragmatic Randomized Clinical Trial Comparing Daily-Delivered Meals to Mailed Frozen Meals. J Appl Gerontol. 2024 Nov;43(11):1605-1610. doi: 10.1177/07334648241248269. Epub 2024 Apr 30. | |
| 38117500 | Derived | Thomas KS, Bunker J, Gadbois E, Hilgeman M, McCreedy E, Mills W, Ornstein KA, Reckrey J, Gutman R. Home-Delivered Meals and Nursing Home Placement Among People With Self-Reported Dementia: A Pilot Pragmatic Clinical Trial. JAMA Netw Open. 2023 Dec 1;6(12):e2347195. doi: 10.1001/jamanetworkopen.2023.47195. |
| Label | URL |
|---|---|
| Peer-reviewed paper describing the results from the qualitative sub-study | View source |
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243 participants were enrolled in the trial.
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
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
This was an intent-to-treat design; meaning, all participants who were enrolled were analyzed, regardless of how long they received meals.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | 95% Confidence Interval | Days | 6 months / 180 days |
|
6 months from randomization/
All-cause Mortality - sites reported deaths
SAE - no SAEs were expected, as intervention does not contain any components with the potential to be life threatening, require or prolong hospitalization, cause persistent or significant disability or incapacity, or result in congenital anomalies or birth defects.
AEs - the potential AEs that could occur during this trial are mild distress, negative emotional reactions, or confusion in response to being interviewed by a data collector.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kali Thomas | Johns Hopkins University | (410) 955-4766 | kali.thomas@jhu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Nov 12, 2023 | Dec 12, 2023 | Prot_SAP_ICF_001.pdf |
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| ID | Term |
|---|---|
| D003704 | Dementia |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
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This is a Phase 1 pilot feasibility study that uses an embedded, pragmatic randomized clinical trial design.
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| Daily home meal delivery | Behavioral | 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. |
|
| Dallas |
| Texas |
| 75247 |
| United States |
| Meals on Wheels - San Antonio | San Antonio | Texas | 78229 | United States |
| 37085899 | Derived | Gadbois EA, Bunker JN, Hilgeman M, Shield R, McAuliff KE, Mills W, Thomas K. Feasibility of conducting qualitative research with persons living with dementia and their caregivers during a home-delivered meals pilot trial. Pilot Feasibility Stud. 2023 Apr 22;9(1):65. doi: 10.1186/s40814-023-01302-5. |
| BG001 |
| 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Lives Alone | Count of Participants | Participants |
|
|
|
| 5 |
| 128 |
| 0 |
| 128 |
| 0 |
| 128 |
| EG001 | 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. | 8 | 115 | 0 | 115 | 0 | 115 |
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| D001523 | Mental Disorders |