Financial Navigation and Peer Support to Improve Diabetes Outcomes

Not Applicable

Recruiting

• Conditions: Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases
• Interventions: Behavioral: Financial Navigation Only; Behavioral: Financial Navigation and Peer Support

• Registration Number: NCT06619834
• Lead Sponsor: University of Michigan

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-27
• Study First Submitted QC: 2024-09-27
• Study First Posted: 2024-10-01
• Status Verified: 2025-02
• Study Start: 2025-02-11
• Last Update Submitted: 2025-02-19
• Last Update Posted: 2025-02-20
• Primary Completion: 2026-02
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 56

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Financial Navigation only	Financial Navigation Only	Financial navigation using software called TailorMed only. The professional Financial Navigator is from the TailorMed team.
Financial Navigation and Peer Support	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.

Primary Outcome Measures

Name	Time	Method
A1c	From enrollment to the end of participant study duration at 6 months	Collect A1c sample using A1c Now SelfCheck test kit
Blood Pressure	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 Outcome Measures

Name	Time	Method
Uptake of social care assistance	From enrollment to the end of participant study duration at 6 months	Adapted from Your Current Life Situation (YCLS) and Health Leads Screening Tools
Successfully having social/financial need address	From enrollment to the end of participant study duration at 6 months	Enrollment data from TailorMed software
Cost-related non-adherence behaviors	From enrollment to the end of participant study duration at 6 months	Individual survey items adapted from National Health Interview Survey (NHIS)
Out-of-pocket costs	From enrollment to the end of participant study duration at 6 months	Data generated from TailorMed software
Diabetes-related social support	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.
Diabetes self-care behaviors	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.
Social needs screening	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.
Diabetes Distress	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.
Treatment-related financial stress	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)

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States