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Addressing Basic Needs to Improve Diabetes Outcomes in Medicaid Beneficiaries

Addressing Basic Needs to Improve Diabetes Outcomes in Medicaid Beneficiaries

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03940209
Enrollment
473
Registered
2019-05-07
Start date
2019-11-01
Completion date
2024-06-30
Last updated
2026-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

Keywords

Low Income Population, Diabetes Mellitus, Type 2, Pragmatic clinical trial

Brief 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.

Detailed description

Type 2 diabetes affects over 29 million US adults, with a disproportionate burden of disease borne by low-income populations. Effective self-management requires attention, planning, follow-through and consistent performance of multiple health behaviors to prevent negative health outcomes. For low-income individuals, though, health improvement is often superseded by the drive to fulfill basic needs such as food, housing, personal safety, and money for necessities. Having unmet basic needs can overwhelm a person's ability to maintain health behaviors. Prior research has demonstrated that with more unmet basic needs, low-income individuals are less likely to even remember or act on a referral for needed health services. However, when unmet needs are resolved and/or people have a personal navigator to help, the likelihood of acting on a health referral significantly increases. Traditionally, patient navigators help coordinate care, manage disease or promote screening and preventive behaviors. This study will expand the role of navigators to include identifying and resolving unmet basic needs, which is expected to facilitate behavior change and improve health outcomes. This approach will be tested in a pragmatic randomized trial conducted in partnership with Louisiana Healthcare Connections, the largest Medicaid managed care plan in Louisiana. This study 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. The primary hypothesis is that intervention participants will have a greater reduction (M=0.5%) in HbA1c pre-post compared with usual care participants. 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. Louisiana Healthcare Connections will identify eligible members for study recruitment and provide basic needs navigation for 6 months. The research team will recruit, enroll, randomize, and survey study participants by phone at baseline and 3-, 6- and 12-month follow up. HbA1c data will be obtained from electronic medical records to assess change.

Interventions

BEHAVIORALBasic needs navigation

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.

Sponsors

Washington University School of Medicine
Lead SponsorOTHER
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
CollaboratorNIH
Louisiana Healthcare Connections
CollaboratorUNKNOWN

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)

Masking description

Survey administrators also will be blinded to individual participant's study group assignment.

Intervention model description

In a pragmatic randomized trial, eligible participants who complete a baseline assessment will be randomly assigned to either a basic needs navigation intervention or usual care.

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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)

Design outcomes

Primary

MeasureTime frameDescription
HbA1c6-12 monthsGlycated haemoglobin (A1c) values will be abstracted from participants' medical record lab reports

Secondary

MeasureTime frameDescription
Health-related Quality of Life12 monthsPhysical and mental health aggregate scores from the Short Form-12 item (SF-12) self-report survey instrument were created following standard scoring guides. Standardized scores are reported with a mean of 50 and standard deviation of 10. Higher scores indicate better health status and better health-related quality of life (e.g., Physical health aggregate (1-100; higher=better health) and Mental health aggregate (1-100; higher=better health).

Countries

United States

Baseline characteristics

Characteristic
Age, Continuous51.6 years
STANDARD_DEVIATION 9.5
Race/Ethnicity, Customized
Hispanic, mixed race, other race
17 Participants
Race/Ethnicity, Customized
Non-Hispanic Black/African American
302 Participants
Race/Ethnicity, Customized
Non-Hispanic White
131 Participants
Region of Enrollment
United States
239 Participants
Sex: Female, Male
Female
180 Participants
Sex: Female, Male
Male
113 Participants
Social Needs2.85 units on a scale
STANDARD_DEVIATION 1.67

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
2 / 2392 / 234
other
Total, other adverse events
0 / 2390 / 234
serious
Total, serious adverse events
0 / 2390 / 234

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 5, 2026