Financial Navigation and Peer Support to Improve Diabetes Outcomes
NCT ID: NCT06619834
Last Updated: 2025-02-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
56 participants
INTERVENTIONAL
2025-02-11
2026-03-31
Brief Summary
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* To examine the feasibility and acceptability of technology-supported financial navigation and financial navigation with peer support
* To examine trends in preliminary efficacy of technology-supported financial navigation and peer support versus financial navigation-alone on 1) A1c and blood pressure (primary outcomes), and 2) out-of-pocket costs, treatment-related financial stress, cost-related non-adherence behaviors, diabetes distress, diabetes self-care behaviors, and uptake of social care assistance (secondary outcomes).
The investigators will assess whether a combined intervention of technology-supported financial navigation and peer support will produce trends in superior diabetes and social care outcomes to financial navigation alone via a 2-arm randomized controlled trial.
Participants will
* Complete 3 survey appointments at baseline, and 3 and 6 months. Each appointment will consist of a survey assessment, an HbA1C test, and two blood pressure readings over the phone.
* Be randomized to either financial navigation only or financial navigation and peer support.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
TRIPLE
Study Groups
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Financial Navigation only
Financial navigation using software called TailorMed only. The professional Financial Navigator is from the TailorMed team.
Financial Navigation Only
A professional financial navigator from TailorMed will use the software to assist participants in exploring options to reduce their specific economic barriers to treatment and care, and non-medical social risks.
Financial Navigation and Peer Support
Financial navigation using software called TailorMed combined with peer support. The professional Financial Navigator is from the TailorMed team. Peer Supporters will be trained community members recruited from Michigan Medicine.
Financial Navigation and Peer Support
A combined intervention of technology-supported financial navigation and peer support: A professional financial navigator from TailorMed will use the software to assist participants in exploring options to reduce their specific economic barriers to treatment and care, and non-medical social risks. Participants will also be matched with a Peer Supporter to help improve the participants\' diabetes self-management.
Interventions
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Financial Navigation and Peer Support
A combined intervention of technology-supported financial navigation and peer support: A professional financial navigator from TailorMed will use the software to assist participants in exploring options to reduce their specific economic barriers to treatment and care, and non-medical social risks. Participants will also be matched with a Peer Supporter to help improve the participants\' diabetes self-management.
Financial Navigation Only
A professional financial navigator from TailorMed will use the software to assist participants in exploring options to reduce their specific economic barriers to treatment and care, and non-medical social risks.
Eligibility Criteria
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Inclusion Criteria
* 18-75 years of age
* diagnosis of diabetes with prescribed anti-hyperglycemic medication
* most recent (within the past 6 months) recorded hemoglobin A1c (HbA1c) level of ≥7.5% for individuals ≤70 years and \>8.0% for individuals between 70-75 years in age
* positive report of financial burden or cost-related non-adherence (CRN) using screening questions developed and validated from prior work 20-22
* be willing to provide personal health information in order to effectively participate in the intervention
Peer Supporters:
* International Classification of Diseases (ICD)-10 code for diabetes
* In the past had A1cs\' \> 8.0% but whose most recent A1c in the prior 12 months is \<8.0%.
* Past experience with economic burden or unmet social risk factors
* Adults 18-75 years
Exclusion Criteria
* a diagnosis of a serious psychiatric disorder (e.g., schizophrenia)
* active alcohol or illicit drug use
* current pregnancy or planning pregnancy
* taking a medication that alters glucose metabolism (e.g., oral steroids)
* report a comorbidity expected to limit life span to \< 3 years
* Participation in another diabetes study, but the investigators will ask them if they would like to be peer supporters
Peer Supporters:
* A diagnosis of a serious psychiatric disorder (e.g., schizophrenia)
* Active alcohol or illicit drug use
* Current pregnancy or planning pregnancy
18 Years
75 Years
ALL
No
Sponsors
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University of Michigan
OTHER
Responsible Party
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Minal Patel
Professor
Locations
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University of Michigan
Ann Arbor, Michigan, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HUM00243207
Identifier Type: -
Identifier Source: org_study_id
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