Addressing Basic Needs to Improve Diabetes Outcomes in Medicaid Beneficiaries

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT03940209
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Basic needs navigation — BEHAVIORAL
    Navigators will help participants address unmet basic needs for 6 months by telephone. Either party can initiate a call. On every call, navigators will: (1) review unmet needs previously reported (baseline survey for first call) and ask participants to report new needs; (2) jointly prioritize among multiple needs based on severity and resource availability; (3) identify community resources that could help solve the problem; (4) evaluate eligibility for those resources; and (5) prepare participants to interact with service agencies and/or act as an advocate on their behalf. On each subsequent call, navigators will review progress toward resolving those needs, assess emergent needs, and adapt priorities accordingly. Navigators will provide instrumental and emotional social support through regular friendly contact, and will attempt to reduce barriers to needs resolution to improve stability and security for participants longer-term.

Study Details

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 Dates

Start date
Nov 1, 2019
Status verified
Apr 2026
Primary completion
Jul 30, 2023
Completion
Jun 30, 2024

Study Design

Enrollment
473 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • No Intervention: Usual care
    Medicaid beneficiaries in this arm will have all the usual resources available to them through their health plan including access to a physician network, case management resources, and other educational and health-focused resources and activities.
  • Experimental: Basic needs navigation
    Medicaid beneficiaries in this arm will have all the usual resources available to them through their health plan (usual care) as well as a navigator for 6 months to address any unmet basic needs, provide instrumental and emotional social support, and improve self-management capabilities.

Primary Outcome Measure

HbA1c [ Time Frame: 6-12 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Washington UniversitySt LouisMissouri63130-

Find similar trials in St Louis, MO

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Washington University· St Louis, MO

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