Addressing Basic Needs to Improve Diabetes Outcomes in Medicaid Beneficiaries

NCT03940209 | Completed Phase 2 Results

• 2 other identifiers: HRPO2018110201R01DK115916-01A1
• Study Type: interventional
• Target: 473
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

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

Outcome Measures

Primary Outcomes (1)

• HbA1c

  Glycated haemoglobin (A1c) values will be abstracted from participants' medical record lab reports

  6-12 months

Secondary Outcomes (1)

• Health-related Quality of Life

  12 months

Study Arms (2)

Usual care

NO INTERVENTION

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.

Basic needs navigation

EXPERIMENTAL

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.

Behavioral: Basic needs navigation

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.

Basic needs navigation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Louisiana Healthcare Connections: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Washington University

St Louis, Missouri, 63130, United States

Location

Related Publications (3)

• Kreuter MW, McQueen A, Boyum S, Fu Q. Unmet basic needs and health intervention effectiveness in low-income populations. Prev Med. 2016 Oct;91:70-75. doi: 10.1016/j.ypmed.2016.08.006. Epub 2016 Aug 3.

  PMID: 27496395 BACKGROUND

• Thompson T, McQueen A, Croston M, Luke A, Caito N, Quinn K, Funaro J, Kreuter MW. Social Needs and Health-Related Outcomes Among Medicaid Beneficiaries. Health Educ Behav. 2019 Jun;46(3):436-444. doi: 10.1177/1090198118822724. Epub 2019 Jan 17.

  PMID: 30654655 BACKGROUND

• McQueen A, Roberts C, Garg R, Caburnay C, Fu Q, Gordon J, Bush T, Pokojski R, Thompson T, Kreuter M. Specialized tobacco quitline and basic needs navigation interventions to increase cessation among low income smokers: Study protocol for a randomized controlled trial. Contemp Clin Trials. 2019 May;80:40-47. doi: 10.1016/j.cct.2019.03.009. Epub 2019 Mar 20.

  PMID: 30904596 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Limitations and Caveats

This trial was paused at the start of the COVID pandemic due to state mandates which paused recruitment and data collection for 3 months and then response rates and staff retention were low during subsequent years of the pandemic, which affected recruitment and retention goals, as well as timely follow up and data collection. We were also unable to obtain specific external lab results of HbA1c tests identified in claims data for most participants.

Results Point of Contact

• Title: Amy McQueen
• Organization: Washington University

amcqueen@wustl.edu

314-935-3715

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Survey administrators also will be blinded to individual participant's study group assignment.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 1, 2019
• First Posted: May 7, 2019
• Study Start: November 1, 2019
• Primary Completion: July 30, 2023
• Study Completion: June 30, 2024
• Last Updated: May 4, 2026
• Results First Posted: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)