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Deliver-EE : évaluation des effets de la livraison de repas

26 octobre 2026 mis à jour par: Brown University

Deliver-EE : Évaluation des effets de la livraison de repas sur la capacité des personnes âgées confinées à la maison à rester dans la communauté via un essai d'efficacité comparative pragmatique, à deux bras et randomisé

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.

Aperçu de l'étude

Statut

Actif, ne recrute pas

Les conditions

Intervention / Traitement

Description détaillée

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

Type d'étude

Interventionnel

Inscription (Réel)

2300

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

66 ans et plus (Adulte plus âgé)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Tout

La description

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)

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Soins de soutien
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: Daily home delivered meals

A lunch-time meal delivered to participants' homes five days per week with wellness check and socialization.
Comportemental: Wellness Check and Socialization

In-home delivery with opportunity for driver observation and interaction

Autre: Prepared Meals

Prepared meals compliant with Older Americans Act nutrition programs guidelines
Expérimental: Frozen, Drop-shipped Meals

Ten frozen meals that are mailed to participants every two weeks.
Autre: Prepared Meals

Prepared meals compliant with Older Americans Act nutrition programs guidelines

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
6-Month Ratio of Days in Institutional Settings
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
3-Month Ratio of Days in Institutional Settings
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Brown University

Collaborateurs

Johns Hopkins University
Meals on Wheels America

Les enquêteurs

  • Chercheur principal: Kali S. Thomas, PhD, Johns Hopkins University School of Nursing
  • Directeur d'études: Kimberly P. Bernard, PhD, Brown University School of Public Health

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 mai 2022

Achèvement primaire (Estimé)

1 août 2027

Achèvement de l'étude (Estimé)

1 mars 2028

Dates d'inscription aux études

Première soumission

27 avril 2022

Première soumission répondant aux critères de contrôle qualité

27 avril 2022

Première publication (Réel)

2 mai 2022

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

28 octobre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

26 octobre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 2022003287
  • IHS-2020C3-21201 (Autre subvention/numéro de financement: Patient-Centered Outcomes Research Institute)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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