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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: Active Phase 2 study of Diabetes Mellitus, Type 2, sponsored by Washington University School of Medicine.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Glycated haemoglobin (A1c) values will be abstracted from participants' medical record lab reports
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 |
What the registry record for NCT03940209 still lists
NCT03940209 is an interventional study that assigns participants to a tested intervention. The registered 473 participants enrollment target is mid-sized for trials with a published cap, below the 4,484-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (89% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Diabetes Mellitus, Type 2
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03940209's enrollment target sits among peer trials
473 82nd of 348 higher than 267 of 348 other Diabetes Mellitus, Type 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetes Mellitus, Type 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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