Home-delivered Meals for Persons With Dementia: Which Model Delays Nursing Home Placement?
NCT ID: NCT04850781
Last Updated: 2024-01-03
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
243 participants
INTERVENTIONAL
2021-04-12
2022-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
D-CARE - The Dementia Care Study: A Pragmatic Clinical Trial of Health System-Based Versus Community-Based Dementia Care
NCT03786471
Partners at Meals - Respite Care and Home (PAM)
NCT03622814
Enhancing Care Coordination: Hospital to Home for Cognitively Impaired Older Adults and Their Caregivers
NCT00294307
Effect of Involving Community-dwelling Older Adults in Activities in Relation to Meals
NCT03289598
Impact of a Multimodal Lifestyle Intervention on Dementia Risk Factors and Attitude Related to Dementia Risk: A Logistical Pilot Study
NCT07146412
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
66 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute on Aging (NIA)
NIH
Meals on Wheels America
OTHER
Brown University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Kali S Thomas, PhD
Role: PRINCIPAL_INVESTIGATOR
Brown University, School of Public Health
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Neighborly Senior Services
Clearwater, Florida, United States
Visiting Nurse Association of Texas
Dallas, Texas, United States
Meals on Wheels - San Antonio
San Antonio, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Related Links
Access external resources that provide additional context or updates about the study.
Peer-reviewed paper describing the results from the qualitative sub-study
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2008002788
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.