NCT03940209CompletedPhase 2
Addressing Basic Needs to Improve Diabetes Outcomes in Medicaid Beneficiaries
Source: ClinicalTrials.gov · Last updated 4 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 473 (actual)
- First submitted
- 1 May 2019
- Start date
- 1 Nov 2019
- Primary completion date
- 30 Jul 2023
- Lead sponsor
- Washington University School of Medicine
- Diseases
- Type 2 diabetes
- NCT number
- NCT03940209
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 473
- From 1 Nov 2019 to the primary completion date, 30 Jul 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Enrolled in case management at Louisiana Healthcare Connections in the 3 months prior to baseline assessment
Other illness
- Are currently pregnant or have only been diagnosed with gestational diabetes at baseline
Lab values
- HbA1c \<7.0 in the 3-4 months prior to baseline assessment
Other
- 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)
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Washington University Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.