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

University of Michigan

Status: Enrolling

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

Treatments: Behavioral: Financial Navigation Only; Behavioral: Financial Navigation and Peer Support

Study type: Interventional

Funder types: Other

Identifiers

NCT06619834

HUM00243207

Details and patient eligibility

About

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.

Enrollment: 56 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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56 participants in 2 patient groups

Financial Navigation only

Active Comparator group

Description:

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

Treatment:

Behavioral: Financial Navigation Only

Financial Navigation and Peer Support

Active Comparator group

Description:

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.

Treatment:

Behavioral: Financial Navigation and Peer Support