Financial Navigation and Peer Support to Improve Diabetes Outcomes

Summary

The goal of this clinical trial pilot study is to test the feasibility, acceptability, and preliminary efficacy of a combined intervention strategy of 1) technology-supported financial navigation to address economic burden of disease and 2) peer support both to facilitate linkages to clinical care and community resources to address social risks and improve participants\' diabetes self-management. The main aims of this pilot study are:

* 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.

Conditions

• Diabetes Mellitus
• Glucose Metabolism Disorders
• Metabolic Diseases
• Endocrine System Diseases

Interventions

BEHAVIORAL

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.

BEHAVIORAL

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.

Sponsors & Collaborators

• University of Michigan

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-02-11

Primary Completion

2026-01-16

Completion

2026-02-04

Countries

• United States

Study Locations