DementiaNCT04850781
Home-delivered Meals for Persons With Dementia: Which Model Delays Nursing Home Placement?
A study testing Bi-weekly frozen meal home delivery and Daily home meal delivery in people with Dementia, run by Brown University at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 66 years and older
- Conditions the study is for
- Dementia
- What is being tested?
- Bi-weekly frozen meal home delivery and Daily home meal delivery
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 243 participants
- Where
- 3 sitesUnited States
- Study dates
- 12 Apr 2021to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 66 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- Residing in a service area where it is not possible to receive the daily-delivered meals.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Neighborly Senior Services
Clearwater, Florida, 33762
Visiting Nurse Association of Texas
Dallas, Texas, 75247
Meals on Wheels - San Antonio
San Antonio, Texas, 78229
About this study
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.
Read the 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.
- Conditions
- Dementia
- Being tested
- Bi-weekly frozen meal home delivery, Daily home meal delivery
- Keywords
- Nutrition, Homebound, Food insecurity
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bi-weekly frozen meal home deliveryBehavioural
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.
Daily home meal deliveryBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Daily Meals | Active comparator | A lunch-time meal delivered to participants' homes multiple times per week with wellness check and socialization. Receives: Behavioral: Daily home meal delivery |
| Frozen, Drop-shipped Meals | Experimental | 10 frozen meals that are mailed to participants every two weeks. Receives: Behavioral: Bi-weekly frozen meal home delivery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months / 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2021
- Study start12 Apr 2021
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by Brown UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a Phase 1 pilot feasibility study that uses an embedded, pragmatic randomized clinical trial design.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 243 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), Meals on Wheels America
- Responsible party
- Sponsor
- Investigators
- Kali S Thomas, PhD, Principal investigator, Brown University, School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04850781
- Sponsor's protocol ID
- 2008002788
- Other IDs
- R61AG070170
- Status last verified
- Dec 2023
- First submitted
- 16 Apr 2021
- Last updated
- 3 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38686741Thomas 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.
PubMed 38117500Gadbois 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.
PubMed 37085899
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home-delivered Meals for Persons With Dementia: Which Model Delays Nursing Home Placement?
- ClinicalTrials.gov ID
- NCT04850781
- Acronym / sponsor ID
- 2008002788
- Conditions
- Dementia
- Keywords
- Nutrition, Homebound, Food insecurity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 243 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA), Meals on Wheels America
- Study start
- 12 Apr 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 20 Apr 2021 (actual)
- Results
- Posted 3 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a Phase 1 pilot feasibility study that uses an embedded, pragmatic randomized clinical trial design.
| Arm | Type | Receives |
|---|---|---|
| Daily Meals | Active comparator | Behavioral: Daily home meal deliveryA lunch-time meal delivered to participants' homes multiple times per week with wellness check and socialization. |
| Frozen, Drop-shipped Meals | Experimental | Behavioral: Bi-weekly frozen meal home delivery10 frozen meals that are mailed to participants every two weeks. |
Who may qualify
- Ages
- 66 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Residing in a service area where it is not possible to receive the daily-delivered meals.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bi-weekly frozen meal home deliveryAll 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. | Behavioural | Frozen, Drop-shipped Meals |
| Daily home meal deliveryAll 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. | Behavioural | Daily Meals |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38686741Bunker 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.
- Derived from this study: PubMed 38117500Thomas 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.
- Derived from this study: PubMed 37085899Gadbois 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.
- Peer-reviewed paper describing the results from the qualitative sub-studyLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kali S Thomas, PhD principal investigator
Brown University, School of Public Health
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bi-weekly frozen meal home delivery and Daily home meal delivery in people with Dementia, run by Brown University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Nursing Home Placement (time frame: 6 months / 180 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04850781, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2024.