Addressing Basic Needs to Improve Diabetes Outcomes in Medicaid Beneficiaries

Completed · Phase 2

Conditions studied: Diabetes Mellitus, Type 2

In brief

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.

Key facts

Study ID

NCT03940209

Run by

Washington University School of Medicine

People needed

473

Starts

2019-11-01

Expected to finish

2024-06-30

Last updated by the study team

2026-05-04

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Medicaid beneficiary
• Member of Louisiana Healthcare Connections
• Age 18-75 years old
• Diagnosed with type 2 diabetes
• Had a HbA1c test in the 3-4 months prior to baseline assessment

You may not qualify if…

• HbA1c <7.0 in the 3-4 months prior to baseline assessment
• Enrolled in case management at Louisiana Healthcare Connections in the 3 months prior to baseline assessment
• Are currently pregnant or have only been diagnosed with gestational diabetes at baseline
• Have cognitive or hearing impairments that significantly impede participation in telephone-based survey and intervention protocols.
• Individuals not living independently (e.g., nursing homes, rehab or correctional facilities)

Where it is running

• Washington University — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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