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NCT03940209 · ClinicalTrials.gov registry record · Phase 2
Addressing Basic Needs to Improve Diabetes Outcomes in Medicaid Beneficiaries
A Phase 2 study of Diabetes Mellitus, Type 2, sponsored by Washington University School of Medicine.
- Active
- Registry status
- Phase 2
- Development phase
- 473
- Enrollment target
- 1
- Study location
NCT03940209 is a Phase 2 study of Diabetes Mellitus, Type 2 that is active but no longer recruiting, run by Washington University School of Medicine. The registered enrollment target is 473 participants, below the 4,484-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03940209, a Phase 2 study of Diabetes Mellitus, Type 2, is active but no longer recruiting, sponsored by Washington University School of Medicine.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 473 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Conditions Studied
Interventions
- BEHAVIORAL Basic needs navigation
Study Locations (1)
Missouri
- Washington University - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 473 participants |
| Start Date | 2019-11-01 |
| Est. Completion | 2024-06-30 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03940209
The ClinicalTrials.gov registry entry for NCT03940209 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 473 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,484-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (89% lower). The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Diabetes Mellitus, Type 2 appearing as the primary indexed condition, and to 1 intervention - of which Basic needs navigation is the first listed.
NCT03940209 reports 1 study location spanning 1 distinct geographic area - top geographies include Missouri.
Frequently Asked Questions
What is clinical trial NCT03940209 about?
NCT03940209 is a clinical study titled "Addressing Basic Needs to Improve Diabetes Outcomes in Medicaid Beneficiaries". 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 safet...
What is the current status of trial NCT03940209?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 473 participants. The study started on 2019-11-01. Estimated completion is 2024-06-30.
What conditions does trial NCT03940209 study?
This clinical trial studies the following conditions: Diabetes Mellitus, Type 2.
What interventions are being tested in trial NCT03940209?
The interventions under investigation include: Basic needs navigation (BEHAVIORAL).
Who is sponsoring clinical trial NCT03940209?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03940209 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.