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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Financial Navigation and Peer Support for Diabetes?

Research shows that peer support can help people with diabetes manage their condition better, potentially reducing the need for medications and hospital visits. Additionally, financial navigation has been effective in helping cancer patients manage financial challenges, suggesting it could also benefit diabetes patients by reducing financial stress. ^{1 2 3 4 5}

Is Financial Navigation and Peer Support for Diabetes safe for humans?

The research articles reviewed focus on peer support for diabetes management, which generally involves non-invasive methods like education and mentoring. These approaches are typically safe as they do not involve medication or medical procedures, but rather support and guidance from peers. ^{6 7 8 9 10}

How does the Financial Navigation and Peer Support treatment for diabetes differ from other treatments?

This treatment is unique because it combines financial navigation, which helps patients manage the costs associated with diabetes care, with peer support, where individuals with diabetes support each other in managing their condition. This approach not only addresses the financial barriers to care but also enhances social and emotional support, which is not typically a focus of standard diabetes treatments. ^{5 10 11 12 13}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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]

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]

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]

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]

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]

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]

References

1. England 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. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

A Pilot Study of a Comprehensive Financial Navigation Program in Patients With Cancer and Caregivers. [2021]

3. England 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. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Financial Assistance Processes and Mechanisms in Rural and Nonrural Oncology Care Settings. [2023]

5. England 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. [2022]

6. United States 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. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Real-world insights from launching remote peer-to-peer mentoring in a safety net healthcare delivery setting. [2022]

8. England 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. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Mobile-Enhanced Peer Support for African Americans with Type 2 Diabetes: a Randomized Controlled Trial. [2022]

10. England pubmed.ncbi.nlm.nih.gov

The New Zealand experience in peer support interventions among people with diabetes. [2018]

11. England 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. [2022]

12. Ireland 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. [2022]

13. England pubmed.ncbi.nlm.nih.gov

Cross-cultural and international adaptation of peer support for diabetes management. [2022]