- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03940209
Addressing Basic Needs to Improve Diabetes Outcomes in Medicaid Beneficiaries
March 26, 2024 updated by: Washington University School of Medicine
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
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For low-income individuals, though, health improvement is often superseded by the drive to fulfill basic needs such as food, housing, personal safety, and money for necessities.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.
Study Type
Interventional
Enrollment (Actual)
473
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Missouri
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Saint Louis, Missouri, United States, 63130
- Washington University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
HbA1c
Time Frame: 12 months
|
Glycated haemoglobin (A1c) values will be abstracted from participants' medical record lab reports reflect average plasma glucose concentration over 8-12 weeks
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Health-related Quality of Life
Time Frame: 12 months
|
Physical and mental summary (subscale) scores from the Short Form-12 item (SF-12) self-report survey instrument will be created following standard scoring guides.
Responses are weighted (using regression weights from a general United States population) then summed then standardized to a mean of 50 and standard deviation of 10 (Range 0-100).
Higher scores indicate better health status and better health-related quality of life.
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2019
Primary Completion (Estimated)
June 30, 2024
Study Completion (Estimated)
June 30, 2024
Study Registration Dates
First Submitted
May 1, 2019
First Submitted That Met QC Criteria
May 3, 2019
First Posted (Actual)
May 7, 2019
Study Record Updates
Last Update Posted (Actual)
March 28, 2024
Last Update Submitted That Met QC Criteria
March 26, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HRPO201811020
- 1R01DK115916-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Investigators may contact study Principal Investigators and complete a data sharing agreement.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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