Addressing Basic Needs to Improve Diabetes Outcomes in Medicaid Beneficiaries
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|ClinicalTrials.gov Identifier: NCT03940209|
Recruitment Status : Not yet recruiting
First Posted : May 7, 2019
Last Update Posted : September 4, 2019
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 2||Behavioral: Basic needs navigation||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||500 participants|
|Intervention Model:||Parallel 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.|
|Masking Description:||Survey administrators also will be blinded to individual participant's study group assignment.|
|Primary Purpose:||Supportive Care|
|Official Title:||Addressing Basic Needs to Improve Diabetes Outcomes in Medicaid Beneficiaries|
|Estimated Study Start Date :||October 15, 2019|
|Estimated Primary Completion Date :||June 30, 2023|
|Estimated Study Completion Date :||June 30, 2024|
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.
Behavioral: Basic 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.
- 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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03940209
|Contact: Amy McQueen, PhDemail@example.com|
|Contact: Matthew Kreuter, PhDfirstname.lastname@example.org|