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Deliver-EE: valutazione degli effetti della consegna dei pasti

26 ottobre 2026 aggiornato da: Brown University

Deliver-EE: valutazione degli effetti della consegna dei pasti sulla capacità degli anziani costretti a casa di rimanere nella comunità attraverso uno studio di efficacia comparativa pragmatico, a due bracci, randomizzato

This study will randomly assign 2,300 older adults on waiting lists at fourteen Meals on Wheels programs in Florida, Illinois, Maryland, Tennessee, Texas, North Carolina, South Carolina, and California into two groups who will receive: (a) daily delivery of meals, five days a week or (b) a shipment of 10 frozen meals, every two weeks. Researchers will examine participants' Medicare claims to understand if differences in healthcare utilization occur between the two groups within six months after they start receiving meals. Researchers will also ask participants questions prior to receiving meals, and again at three months, to understand how meals impact their ability to obtain food, their feelings of loneliness, and their overall quality of life. The primary study outcome will be the ratio of days spent in institutional settings (i.e., hospital, nursing home) in the six months after participants begin receiving meals. The secondary outcomes include the ratio of days spent in institutional settings in the three months after participants begin receiving meals, food insecurity, subjective isolation/loneliness, and health-related quality of life. The team will also examine differences in dietary intake between the two groups as an exploratory outcome.

Panoramica dello studio

Stato

Attivo, non reclutante

Condizioni

Sano

Intervento / Trattamento

Descrizione dettagliata

Background and Significance: Food insecurity among older adults is a critical public health issue with implications for families, the healthcare system, and society. In 2017, an estimated 5.5 million older adults (7.7%) in the United States were food insecure. Among older adults, food insecurity is associated with poor health status and outcomes and accounts for an estimated $130 billion annually in medical expenses. As a result, healthcare entities (e.g., payers, integrated systems, providers) are increasingly interested in addressing food insecurity, among other social risk factors, through non-medical services such as home-delivered meals to older patients and enrollees. Home-delivered meals, long provided through a network of community-based organizations funded through the Older Americans Act, state dollars, and charitable contributions, promote food security, socialization, and independence among older adults. While meals have traditionally been provided daily to clients' homes by a volunteer or paid driver, mailed frozen meals have emerged in recent years as a lower cost alternative. However, there is limited evidence about what mode of delivery is most effective in promoting community independence, reducing healthcare utilization, and improving patients' quality of life, as well as how these outcomes may vary as a function of patients' preferences for how meals are delivered to them.

Study Aims: The long-term goal of this research is to generate evidence to guide patient, family, meal programs, and healthcare entities' decision-making about which mode of meal delivery is best for promoting important, patient-centered outcomes. This will be accomplished through three specific aims: 1) To evaluate the effectiveness of receiving daily-delivered meals with a safety check and socialization versus frozen, drop-shipped meals on food insecure, homebound older adults' ability to remain in the community; 2) To understand food insecure, homebound older adults' preferences for mode of meal delivery and the effect of receiving a meal that is concordant with their preference on their ability to remain in the community; and 3) To measure and quantify secondary outcomes prioritized by stakeholders related to these different modes of meal delivery.

Study Description: This is a two-arm pragmatic, randomized controlled trial that will compare participants' health outcomes between two conventional approaches for delivering meals to food insecure, homebound older adults at fourteen diverse Meals on Wheels America member programs in Florida, Illinois, Maryland, Tennessee, Texas, California, North Carolina, and South Carolina. The comparators are the two main modes of meal delivery used in everyday practice: daily-delivered meals and drop-shipped, frozen meals. A total of 2300 food insecure, homebound older adults (ages 66+) on waiting lists at these programs will be enrolled in the study; 1150 older adults will receive meals delivered five days per week, with socialization and a wellness check by a volunteer or paid driver, and 1150 will receive a box of 10 frozen meals that will be mailed to participants every two weeks. The primary outcome will be the ratio of days that a participant is in an institutional setting (i.e., hospital, nursing home) in the six months following the start of meal delivery and will be derived from data from the Centers for Medicare and Medicaid Services; secondary outcomes include the ratio of days in institutional settings in the three months following the start of meal delivery, food insecurity, loneliness, and quality of life. Secondary outcomes will be derived from Centers for Medicare and Medicaid Services' data and surveys with participants. Self-reported dietary intake will be included as an exploratory outcome. To examine heterogeneity of treatment effects, the investigators will test for interactions between the two types of meals and participants' preferences for meals, as well as clients' living arrangements. This research will be the first to prospectively evaluate the comparative effectiveness of the two predominant meal delivery options in partnership with a variety of stakeholders. The knowledge generated from this research will be of tremendous value to healthcare payers, health systems, providers, community-based organizations, patients, and their families, because it will identify the mode of meal delivery that best meets older, homebound, and food insecure patients' needs and promotes community independence

Tipo di studio

Interventistico

Iscrizione (Effettivo)

2300

Fase

Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

Stati Uniti
- California
  - San Diego, California, Stati Uniti, 92110
    - Meals on Wheels San Diego County
- Florida
  - Clearwater, Florida, Stati Uniti, 33762
    - Neighborly Care Network
  - Jacksonville, Florida, Stati Uniti, 32210
    - Aging True
- Illinois
  - Evanston, Illinois, Stati Uniti, 60201
    - Meals on Wheels Northeastern Illinois
- Maryland
  - Baltimore, Maryland, Stati Uniti, 21224
    - Meals on Wheels of Central Maryland
- North Carolina
  - Durham, North Carolina, Stati Uniti, 27703
    - Meals On Wheels Durham
  - Greensboro, North Carolina, Stati Uniti, 27408
    - Senior Resources of Guilford
- South Carolina
  - Anderson, South Carolina, Stati Uniti, 29624
    - Meals On Wheels - Anderson
  - Columbia, South Carolina, Stati Uniti, 29205
    - Senior Resources Inc
- Tennessee
  - Memphis, Tennessee, Stati Uniti, 38126
    - Metropolitan Inter-Faith Association (MIFA)
- Texas
  - Dallas, Texas, Stati Uniti, 75247
    - Visiting Nurse Association of Texas
  - Houston, Texas, Stati Uniti, 77090
    - Northwest Assistance Ministries
  - Mission, Texas, Stati Uniti, 78572
    - Amigos Del Valle, Inc
  - San Antonio, Texas, Stati Uniti, 78229
    - Meals on Wheels San Antonio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

66 anni e precedenti (Adulto più anziano)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

Age 66+
On program waiting list
Must reside in program's daily service area
Must be able to eat a general diet with no dietary restrictions

Exclusion Criteria:

Primary language is not English or Spanish
Has end stage renal disease/requires specialized renal diet
Unable to participate in a phone survey/interview (e.g., difficulty hearing, lack of comprehension of study purpose, does not have working phone)

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Scopo principale: Terapia di supporto
Assegnazione: Randomizzato
Modello interventistico: Assegnazione parallela
Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm Gruppo di partecipanti / Arm Un gruppo o sottogruppo di partecipanti a uno studio clinico che riceve un intervento/trattamento specifico o nessun intervento, secondo il protocollo dello studio.	Intervento / Trattamento Intervento / Trattamento Un processo o un'azione che è al centro di uno studio clinico. Gli interventi includono farmaci, dispositivi medici, procedure, vaccini e altri prodotti sperimentali o già disponibili. Gli interventi possono anche includere approcci non invasivi, come l'educazione o la modifica della dieta e dell'esercizio fisico.
Comparatore attivo: Daily home delivered meals A lunch-time meal delivered to participants' homes five days per week with wellness check and socialization.	Comportamentale: Wellness Check and Socialization In-home delivery with opportunity for driver observation and interaction Altro: Prepared Meals Prepared meals compliant with Older Americans Act nutrition programs guidelines
Sperimentale: Frozen, Drop-shipped Meals Ten frozen meals that are mailed to participants every two weeks.	Altro: Prepared Meals Prepared meals compliant with Older Americans Act nutrition programs guidelines

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato	Misura Descrizione	Lasso di tempo
6-Month Ratio of Days in Institutional Settings Lasso di tempo: 6 months	Ratio between the number of days that are spent in an institutional setting (i.e., acute care hospital, psychiatric hospital, long-term care hospital, nursing home, or skilled nursing facility) and the number of days alive in the six months following receipt of meals	6 months

Misure di risultato secondarie

Misura del risultato	Misura Descrizione	Lasso di tempo
3-Month Ratio of Days in Institutional Settings Lasso di tempo: 3 months	Defined similarly to the primary outcome, but assesses the immediate (3-month) impact of meals on days spent in institutional settings	3 months
Food Insecurity Lasso di tempo: 3 months	U.S. Household Food Security Survey Module: Six-Item Short Form; Minimum value (0) indicates high food insecurity; Maximum value (6) indicates very low food insecurity	3 months
Subjective Isolation/Loneliness Lasso di tempo: 3 months	University of California, Los Angeles 3-Item Loneliness Scale; Minimum value (3) indicates low feelings of loneliness; Maximum value (9) indicates high feelings of loneliness	3 months
Health-Related Quality of Life Lasso di tempo: 3 months	The Centers for Disease Control and Prevention's Health-Related Quality of Life 4-question core modules, called the "Healthy Days Measures"; The unhealthy days index is calculated by summing the number of physically and mentally unhealthy days, capped at 30 total days.	3 months

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Brown University

Collaboratori

Johns Hopkins University

Meals on Wheels America

Investigatori

Investigatore principale: Kali S. Thomas, PhD, Johns Hopkins University School of Nursing
Direttore dello studio: Kimberly P. Bernard, PhD, Brown University School of Public Health

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 maggio 2022

Completamento primario (Stimato)

1 agosto 2027

Completamento dello studio (Stimato)

1 marzo 2028

Date di iscrizione allo studio

Primo inviato

27 aprile 2022

Primo inviato che soddisfa i criteri di controllo qualità

27 aprile 2022

Primo Inserito (Effettivo)

2 maggio 2022

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

28 ottobre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

26 ottobre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

2022003287
IHS-2020C3-21201 (Altro numero di sovvenzione/finanziamento: Patient-Centered Outcomes Research Institute)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Deliver-EE: valutazione degli effetti della consegna dei pasti