Financial Navigation and Peer Support to Improve Diabetes Outcomes (FNaPS)

Pilot Trial of Financial Navigation and Peer Support to Improve Diabetes Outcomes

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.

Study Overview

• Status: Completed
• Conditions: Glucose Metabolism Disorders; Metabolic Diseases; Diabetes Mellitus; Endocrine System Diseases
• Intervention / Treatment: Behavioral: Financial Navigation Only; Behavioral: Financial Navigation and Peer Support

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Participants:

• 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:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Financial Navigation only; Financial navigation using software called TailorMed only. The professional Financial Navigator is from the TailorMed team.	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.
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Uptake of social care assistance	Adapted from Your Current Life Situation (YCLS) and Health Leads Screening Tools	From enrollment to the end of participant study duration at 6 months
Successfully having social/financial need address	Enrollment data from TailorMed software	From enrollment to the end of participant study duration at 6 months
Cost-related non-adherence behaviors	Individual survey items adapted from National Health Interview Survey (NHIS)	From enrollment to the end of participant study duration at 6 months
Out-of-pocket costs	Data generated from TailorMed software	From enrollment to the end of participant study duration at 6 months
Diabetes-related social support	Diabetes Support Scale (DSS) Minimum value- Strongly Disagree, Maximum value- Strongly Agree Higher score mean a better outcome.	From enrollment to the end of participant study duration at 6 months
Diabetes self-care behaviors	Diabetes Self-care Activities Scale - Adapted Minimum value- 0 Days, Maximum value- 7 Days Higher scores mean a better outcome.	From enrollment to the end of participant study duration at 6 months
Social needs screening	Accountable Health Communities Health-Related Social Needs Screening Tool (Q15-17) and Item adapted from National Health Interview Survey (Q18) Adapted from Accountable Health Communities Health-Related Social Needs Screening Tool, Health Leads Social Needs Screening Toolkit, & Kaiser Permanente Your Current Life Situation Questionnaire Minimum value- Never True, Maximum value- Often True. Higher scores mean worse outcome.	From enrollment to the end of participant study duration at 6 months
Diabetes Distress	Diabetes Distress Scale (DDS2 version) Minimum Value- Not a Problem, Maximum Value- Serious Problem Higher scores mean worse outcome.	From enrollment to the end of participant study duration at 6 months
Treatment-related financial stress	COmprehensive Score for financial Toxicity (COST)-Functional Assessment of Chronic Illness Therapy (FACIT) domains adapted for diabetes The score includes reverse-coding 6-items, summing all items, multiplying sum by 11 and dividing the total by number of items answered. Lower scores indicate higher perceptions of financial burden. (Min value of 0, max value of 44)	From enrollment to the end of participant study duration at 6 months

Collaborators and Investigators

• Sponsor: University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): February 11, 2025
• Primary Completion (Actual): January 16, 2026
• Study Completion (Actual): February 4, 2026

Study Registration Dates

• First Submitted: September 27, 2024
• First Submitted That Met QC Criteria: September 27, 2024
• First Posted (Actual): October 1, 2024

Study Record Updates

• Last Update Posted (Actual): March 5, 2026
• Last Update Submitted That Met QC Criteria: March 4, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutritional and Metabolic Diseases; Diabetes Mellitus; Metabolic Diseases; Glucose Metabolism Disorders; Endocrine System Diseases
• Other Study ID Numbers: HUM00243207

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All of the individual participant data that underlie results in a publication, after de-identification.
• IPD Sharing Time Frame: Beginning 3 months and ending 5 years following article publication
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No