Financial Navigation and Peer Support to Improve Diabetes Outcomes

NCT06619834 | Completed

• 1 other identifier: HUM00243207
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• A1c

  Collect A1c sample using A1c Now SelfCheck test kit

  From enrollment to the end of participant study duration at 6 months

• Blood Pressure

  Measure participant blood pressure using the Omron home blood pressure monitor. Both systolic and diastolic blood pressure will be measured.

  From enrollment to the end of participant study duration at 6 months

Secondary Outcomes (9)

• Uptake of social care assistance

  From enrollment to the end of participant study duration at 6 months

• Successfully having social/financial need address

  From enrollment to the end of participant study duration at 6 months

• Cost-related non-adherence behaviors

  From enrollment to the end of participant study duration at 6 months

• Out-of-pocket costs

  From enrollment to the end of participant study duration at 6 months

• Diabetes-related social support

  From enrollment to the end of participant study duration at 6 months

Study Arms (2)

Financial Navigation only

ACTIVE COMPARATOR

Financial navigation using software called TailorMed only. The professional Financial Navigator is from the TailorMed team.

Behavioral: Financial Navigation Only

Financial Navigation and Peer Support

ACTIVE COMPARATOR

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.

Behavioral: Financial Navigation and Peer Support

Interventions

Financial Navigation and Peer Support BEHAVIORAL

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 and Peer Support

Financial Navigation Only BEHAVIORAL

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 only

Eligibility Criteria

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

You may qualify if:

• Participants:
• 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

You may not qualify if:

• Participants:
• 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

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 27, 2024
• First Posted: October 1, 2024
• Study Start: February 11, 2025
• Primary Completion: January 16, 2026
• Study Completion: February 4, 2026
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ANALYTIC CODE
• Time Frame: Beginning 3 months and ending 5 years following article publication
• Access Criteria: The data will be made available to other researchers who provide a methodologically sound proposal and who have appropriate approvals from all relevant Institutional Review Boards (IRBs). The data will be shared for analyses to achieve aims in the approved proposal. Data will be shared through a secure File Transfer Protocol (FTP) site through encryption protocols that allow secure uploading of files with data sharing limited to specific users. Select datasets will also be made available through the University of Michigan openICPSR Repository (http://www.icpsr.umich.edu/icpsrweb/deposit/index.jsp). Proposals should be directed to minalrp@umich.edu. To gain access, data requestors will need to sign a data access agreement.

Locations

US (1)