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NCT03940209

Addressing Basic Needs to Improve Diabetes Outcomes in Medicaid Beneficiaries

Status unknown Phase 2 Last updated 28 March 2024
What this trial tests

Phase 2 trial testing Basic needs navigation in Diabetes Mellitus, Type 2 in 473 participants. Status unknown.

Timeline
1 November 2019
Primary endpoint
30 June 2024
30 June 2024

Quick facts

Lead sponsorWashington University School of Medicine
PhasePhase 2
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposesupportive care
Enrollment473
Start date1 November 2019
Primary completion30 June 2024
Estimated completion30 June 2024
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Washington University School of Medicine

Who can join

Adults 18 to 75, any sex, with Diabetes Mellitus, Type 2. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This pragmatic randomized trial will test the effectiveness of a basic needs navigation intervention compared to usual care among 500 adults (ages 18-75) with Medicaid, type 2 diabetes, and 1 or more unmet basic needs. Basic needs includes having such things as adequate food, housing, personal safety, and money for necessities. The primary study hypothesis is that participants who receive navigation to address unmet basic needs will have a greater reduction (M=0.5%) in HbA1c pre-post compared with participants receiving usual care. Consistent with the study's conceptual model, the effects of unmet basic needs on barriers to self-care (e.g., attention, stress, sleep), health behaviors (e.g., glucose monitoring, diet, clinical screenings) and health outcomes (e.g., emergency department utilization, hospitalization, quality of life) will be examined.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. A Randomized Controlled Trial Testing the Effects of a Social Needs Navigation Intervention on Health Outcomes and Healthcare Utilization among Medicaid Members with Type 2 Diabetes.
    McQueen A, von Nordheim D, Caburnay C, Li L, et al · · 2024 · cited 1× · PMID 39063512 · DOI 10.3390/ijerph21070936
  2. Correlates of Self-Reported Executive Function Impairment Among Medicaid Beneficiaries With Type 2 Diabetes.
    Von Nordheim D, Herrick C, Verdecias N, Garg R, et al · · 2024 · PMID 39649689 · DOI 10.2337/ds23-0067

Verify or expand the search:

Other recruiting trials for Diabetes Mellitus, Type 2

Currently open trials in the same condition.

Other Washington University School of Medicine trials

Trials by the same sponsor.

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Data sources for this page

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