Financial Navigation and Peer Support for Diabetes

(FNaPS Trial)

Overseen By Minal R. Patel, Ph.D, M.P.H

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Must be taking: Anti-hyperglycemic

Must not be taking: Oral steroids

Disqualifiers: Serious psychiatric disorder, active substance use, pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

56 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help people with diabetes manage their health and financial challenges. It tests two approaches: one group receives assistance navigating healthcare costs using special software, while the other group receives the same financial help plus support from peers who have faced similar challenges. The study will determine if adding peer support leads to better health outcomes and reduced financial stress. Participants with diabetes who take medication and struggle with healthcare costs are sought. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance support systems for managing diabetes and healthcare costs.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are taking a medication that alters glucose metabolism, you may not be eligible to participate.

What prior data suggests that this intervention strategy is safe?

Research has shown that financial navigation, with or without peer support, is generally safe for people with diabetes. Studies indicate that peer support can improve blood sugar and blood pressure control in diabetes patients, suggesting that adding peer support to financial navigation does not introduce new safety concerns.

Research also shows that financial navigation alone can enhance blood sugar control and increase clinic visits, indicating that this approach is well tolerated and poses no significant risks.

Both strategies are non-invasive and emphasize support rather than medical treatment, making physical side effects unlikely. Participants have reported benefits in managing their condition with these methods, without significant negative effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial with Financial Navigation and Peer Support for diabetes because it tackles the financial barriers that often hinder effective diabetes management. Unlike traditional diabetes treatments that focus on medications and lifestyle changes, these interventions integrate financial navigation using software called TailorMed, which helps patients manage the costs associated with their care. The addition of peer support, involving trained community members from Michigan Medicine, offers emotional and practical guidance, creating a more holistic support system. This approach could lead to better adherence to treatment plans by alleviating financial stress and providing community-based encouragement, potentially leading to improved health outcomes.

What evidence suggests that this trial's treatments could be effective for diabetes?

This trial will compare two approaches: Financial Navigation and Peer Support, and Financial Navigation Only. Studies have shown that peer support can help people with type 2 diabetes improve blood sugar and blood pressure. Research indicates that peer support programs often lead to better diabetes management. Additionally, helping patients understand their finances has been linked to better diabetes knowledge and improved blood sugar levels. Financial guidance can positively affect diabetes management and self-care. Overall, both financial guidance and peer support show promise in helping people manage diabetes more effectively. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for adults aged 18-75 with diabetes who have experienced financial burden or cost-related non-adherence to treatment. They must be willing to share personal health information, have a recent HbA1c level of ≥7.5% (or >8.0% if between 70-75 years), and take prescribed anti-hyperglycemic medication.

Inclusion Criteria

Participants must have a positive report of financial burden or cost-related non-adherence (CRN) using screening questions developed and validated from prior work

Participants must be willing to provide personal health information in order to effectively participate in the intervention

Peer Supporters must have an International Classification of Diseases (ICD)-10 code for diabetes

Exclusion Criteria

Participants with active alcohol or illicit drug use

Peer Supporters with active alcohol or illicit drug use

Participants with a diagnosis of a serious psychiatric disorder (e.g., schizophrenia)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete a baseline survey assessment, an HbA1C test, and two blood pressure readings over the phone

1 week

1 visit (virtual)

Intervention

Participants receive either financial navigation only or financial navigation combined with peer support

6 months

3 visits (virtual) at baseline, 3 months, and 6 months

Follow-up

Participants are monitored for changes in A1c, blood pressure, and other secondary outcomes

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Financial Navigation and Peer Support
• Financial Navigation Only

Trial Overview

The study tests the impact of technology-supported financial navigation alone versus combined with peer support on diabetes management outcomes. It measures A1c levels, blood pressure, out-of-pocket costs, stress related to finances, adherence behaviors, distress from diabetes, self-care actions, and use of social care resources.

How Is the Trial Designed?

Group I: Financial Navigation and Peer Support Active Control 1 Intervention

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.

Group II: Financial Navigation only Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

Published Research Related to This Trial

Peer support can enhance self-management for people with diabetes by providing essential resources and support tailored to specific cultural and health system contexts, focusing on daily management, emotional support, and connections to clinical care.

The Robert Wood Johnson Foundation Diabetes Initiative identified key functions of peer support that can be adapted locally, emphasizing the importance of measuring implementation and participant feedback to evaluate the effectiveness of these programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cross-cultural and international adaptation of peer support for diabetes management. Fisher, EB., Earp, JA., Maman, S., et al.[2022]

A 3-month diabetes self-management education (DSME) program alone did not lead to improvements in glycated hemoglobin (HbA1c) levels for either the peer support or control group over 15 months.

However, participants who received 12 months of peer support after the DSME program showed significant improvements in cardiovascular disease risk factors, including lower cholesterol, blood pressure, and body mass index, compared to those who only received the DSME program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peer-Led, Empowerment-Based Approach to Self-Management Efforts in Diabetes (PLEASED): A Randomized Controlled Trial in an African American Community. Tang, TS., Funnell, MM., Sinco, B., et al.[2022]

Peer support programs can significantly enhance social and emotional support for adults with diabetes, helping them manage their condition more effectively between healthcare visits.

These programs not only assist with daily diabetes management but also promote connections to clinical care, indicating a promising avenue for improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Different models to mobilize peer support to improve diabetes self-management and clinical outcomes: evidence, logistics, evaluation considerations and needs for future research. Heisler, M.[2022]

Chronic diseases like diabetes require significant lifestyle changes and self-management, with patients and their families taking on 99% of the care responsibilities, highlighting the importance of education and support.

Peer-based programs have been identified as effective in providing ongoing support and behavioral strategies for diabetes management, helping patients cope with the emotional and practical challenges of living with the disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peer-based behavioural strategies to improve chronic disease self-management and clinical outcomes: evidence, logistics, evaluation considerations and needs for future research. Funnell, MM.[2022]

Face-to-face and telephone-based peer support programs for diabetes self-management have shown the most promise in improving outcomes for individuals with type 2 diabetes, based on a review of 76 studies from 2007 to 2021.

Cultural competency is crucial for the success of peer support initiatives, and there is a need for careful recruitment and training of peer supporters to ensure sustainable and effective programs in community settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Type 2 diabetes peer support interventions as a complement to primary care settings in high-income nations: A scoping review. Lu, S., Leduc, N., Moullec, G.[2022]

A study involving 1299 participants across 130 clusters found that both 1:1 and group diabetes peer support strategies are cost-effective, saving an average of £233.65 and £90.52 per participant per year, respectively.

The peer support interventions not only reduced NHS costs by £138.38 per participant annually but also highlighted the importance of self-reported healthcare utilization in achieving these savings, suggesting a potential for improved diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can peer support be cost saving? An economic evaluation of RAPSID: a randomized controlled trial of peer support in diabetes compared to usual care alone in East of England communities. Wingate, L., Graffy, J., Holman, D., et al.[2022]

A 24-month group-based peer support program for type 2 diabetes patients significantly reduced the length of hospital stays by an average of 40.13 days compared to control groups, suggesting improved management of the condition.

While the program did not affect the number of prescribed drugs or hospital admissions, it demonstrated potential cost savings of approximately €1660.60 per patient per year by decreasing hospital stay duration, indicating a cost-effective approach to diabetes care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cost analysis of a peer support programme for patients with type 2 diabetes: a secondary analysis of a controlled trial. Johansson, T., Keller, S., Sönnichsen, AC., et al.[2022]

A program providing financial counseling and assistance was successfully implemented for 30 patients with solid tumors and their caregivers, showing a high participation rate of 78% among dyads.

Despite receiving $11,000 in assistance, the financial hardship and caregiver burden scores did not significantly change, indicating that while participants were willing to engage, the program's immediate impact on alleviating financial stress may need further evaluation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Pilot Study of a Comprehensive Financial Navigation Program in Patients With Cancer and Caregivers. Watabayashi, K., Steelquist, J., Overstreet, KA., et al.[2021]

This study will evaluate the effectiveness of peer coaching in improving diabetes outcomes among 400 low-income patients with poorly controlled diabetes over a 6-month period, focusing on changes in HbA1c levels as the primary outcome.

Peer coaches, who are trained patients with diabetes, may enhance self-management skills and clinical outcomes, potentially providing a cost-effective solution to improve diabetes care in resource-limited settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of peer health coaching in improving glycemic control among low-income patients with diabetes: protocol for a randomized controlled trial. Ghorob, A., Vivas, MM., De Vore, D., et al.[2022]

Diabetes peer support initiatives in New Zealand, led by organizations like Diabetes New Zealand, have shown potential in assisting individuals with diabetes, particularly through trained lay educators providing personalized support.

Despite the positive feedback on these programs, there has been no quantitative evaluation of their health impact, indicating a need for formal assessment to better understand their effectiveness in diabetes prevention and management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The New Zealand experience in peer support interventions among people with diabetes. Simmons, D., Voyle, J., Rush, E., et al.[2018]

In a real-world evaluation of a remote diabetes intervention involving 974 patients, 71% enrolled and 90% of those participated in coaching, demonstrating high engagement in the program.

Participants who completed the program showed a significant reduction in hemoglobin A1c levels by 1.71%, indicating improved diabetes management through remote peer mentoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-world insights from launching remote peer-to-peer mentoring in a safety net healthcare delivery setting. Lyles, CR., Sarkar, U., Patel, U., et al.[2022]

In a study involving 120 African American adults with poorly controlled type 2 diabetes, both community-based diabetes self-management education (DSME) and DSME with mobile health (mHealth)-enhanced peer support led to significant reductions in hemoglobin A1c (A1C) levels, indicating improved glycemic control.

Participants receiving the mHealth-enhanced peer support experienced a greater reduction in diabetes distress compared to those who only received DSME, suggesting that integrating peer support with clinical care can enhance emotional wellbeing in managing diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile-Enhanced Peer Support for African Americans with Type 2 Diabetes: a Randomized Controlled Trial. Presley, C., Agne, A., Shelton, T., et al.[2022]

A study involving 83 stakeholders from 10 oncology care sites revealed that financial navigation (FN) is crucial for addressing the financial hardships faced by cancer patients, highlighting the need for systematic implementation of FN processes.

Key barriers to effective financial assistance included insufficient staff resources and challenges in identifying patient needs, while open communication among staff and patients was identified as a significant facilitator in both rural and nonrural settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Financial Assistance Processes and Mechanisms in Rural and Nonrural Oncology Care Settings. Biddell, CB., Spees, LP., Petermann, V., et al.[2023]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8576070/

Long-Term Effects of Financial Incentives for General ...

To assess both long-term effects and sustainability of financial incentives for general practitioners (GPs) in the treatment of patients with diabetes mellitus.

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10433589/

The impact of patient navigation on glycemic control ...

After the intervention, glycemic control improved in 37 (24.3%) participants (p < 0.001), and knowledge about diabetes also improved in 37 (24.3 ...

3.

sccdcollaborative.org

sccdcollaborative.org/project/financial-navigation-and-peer-support-to-improve-diabetes-outcomes/

Financial Navigation and Peer Support to Improve Diabetes ...

We are engaging 50 patients with uncontrolled diabetes and unmet social risk factors. Outcomes will be assessed at baseline and 3- and 6-month follow-up via ...

4.

trialsjournal.biomedcentral.com

trialsjournal.biomedcentral.com/articles/10.1186/s13063-024-08513-y

Effectiveness of a digital health and financial incentive ... - Trials

This study will provide new evidence of the long-term effectiveness of an activity rewards scheme focused on increasing physical activity conducted within ...

5.

sciencedirect.com

sciencedirect.com/science/article/pii/S2211335516301486

Community to clinic navigation to improve diabetes outcomes

Primary outcomes included: (1) changes in HbA1c, blood pressure, lipids, and BMI and (2) changes in self-management activities (blood glucose monitoring, diet, ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5699176/

Patient navigation to improve diabetes outpatient care at a ...

Navigation was associated with improved glycemic control and better clinic engagement among patients with diabetes.

7.

bmchealthservres.biomedcentral.com

bmchealthservres.biomedcentral.com/articles/10.1186/s12913-017-2700-7

Patient navigation to improve diabetes outpatient care at a ...

The objective of this study was to evaluate the effect of a patient navigation program on medical and administrative outcomes among patients ...

8.

withpower.com

withpower.com/trial/phase-glucose-metabolism-disorders-8-2024-48d1f

Financial Navigation and Peer Support for Diabetes

Trial Overview The study tests the impact of technology-supported financial navigation alone versus combined with peer support on diabetes management outcomes.

9.

jamanetwork.com

jamanetwork.com/journals/jamanetworkopen/fullarticle/2836886

Type 2 Diabetes and Financial Outcomes | Public Health

Patients with diabetes experienced more adverse financial outcomes (1.9 vs 1.2) and had lower credit scores (mean [SE], 618.7 [0.4] vs 664.2 [ ...

10.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12075023/

Financial Toxicity in Diabetes: The State of What We Know

Data indicates 30–60% of diabetes patients experience financial toxicity, with household expenditures ranging from 5 to 40% of income on ...