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Completed

NCT Number: NCT06619834

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.

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 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.

Primary outcomes

  1. A1c

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

    Collect A1c sample using A1c Now SelfCheck test kit

  2. Blood Pressure

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

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

Secondary outcomes

  1. Uptake of social care assistance

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

    Adapted from Your Current Life Situation (YCLS) and Health Leads Screening Tools

  2. Successfully having social/financial need address

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

    Enrollment data from TailorMed software

  3. Cost-related non-adherence behaviors

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

    Individual survey items adapted from National Health Interview Survey (NHIS)

  4. Out-of-pocket costs

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

    Data generated from TailorMed software

  5. Diabetes-related social support

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

    Diabetes Support Scale (DSS) Minimum value- Strongly Disagree, Maximum value- Strongly Agree Higher score mean a better outcome.

  6. Diabetes self-care behaviors

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

    Diabetes Self-care Activities Scale - Adapted Minimum value- 0 Days, Maximum value- 7 Days Higher scores mean a better outcome.

  7. Social needs screening

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

    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.

  8. Diabetes Distress

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

    Diabetes Distress Scale (DDS2 version)

    Minimum Value- Not a Problem, Maximum Value- Serious Problem Higher scores mean worse outcome.

  9. Treatment-related financial stress

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

    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)

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Official study title

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

Acronym: FNaPS

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 1, 2024
Registry last updated
Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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