Financial Incentives + Nurse Coaching for Type 2 Diabetes

(FINANCE-DM Trial)

Recruiting at 1 trial location

Overseen By Elise A Mosley-Johnson, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: State University of New York at Buffalo

Disqualifiers: Dementia, Drug abuse, Psychosis, others

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

Compensation: Varies

Number of Visits: 21

Duration: 12 months

450 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The objective of this protocol is to answer the questions: 1) Are financial incentives layered upon nurse education and home telemonitoring superior to nurse education and home telemonitoring alone in improving metabolic control long term? 2) Are the effects of financial incentives on metabolic control sustained once the incentives are withdrawn? and 3) Are financial incentives efficacious within and consistent across racial/ethnic groups? This study provides a unique opportunity to address these gaps in the literature. Investigators propose a randomized controlled trial to test the efficacy of a Financial Incentives And Nurse Coaching to Enhance Diabetes Outcomes (FINANCE-DM) intervention comprised of: 1) nurse education, 2) home telemonitoring, and 3) structured financial incentives; compared to an active control group (nurse education and home telemonitoring alone). The study also will evaluate whether intervention effects are sustained 6 months after the financial incentives are withdrawn (i.e. 18 months post randomization); and whether the intervention is differentially efficacious across racial/ethnic groups.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on financial incentives and nurse coaching rather than medication changes.

Is mindfulness-based stress reduction safe for people with diabetes?

Mindfulness-based stress reduction (MBSR) has been studied in people with diabetes and generally shows improvements in stress and diabetes management without significant safety concerns. Participants in these studies reported high satisfaction and no major adverse effects were noted. ^{1 2 3 4 5}

How is the FINANCE-DM treatment different from other treatments for type 2 diabetes?

The FINANCE-DM treatment is unique because it combines financial incentives and nurse coaching with mindfulness-based stress reduction (MBSR) techniques, which focus on reducing stress and improving self-management in diabetes care. This approach is different from traditional treatments that primarily focus on medication and diet, as it emphasizes mental well-being and stress management to help control diabetes. ^{1 2 3 5 6}

What data supports the effectiveness of this treatment for Type 2 Diabetes?

Research shows that mindfulness-based stress reduction (MBSR) therapy, when led by nurses, can significantly reduce diabetes distress and improve self-management in people with Type 2 Diabetes. Additionally, mindfulness-based interventions have been found to improve psychological outcomes and quality of life for individuals with diabetes. ^{2 3 5 6 7}

Who Is on the Research Team?

Leonard Egede, MD

Principal Investigator

State University of New York at Buffalo

Are You a Good Fit for This Trial?

This trial is for adults over 21 with Type 2 Diabetes, specifically those who have not managed to control their blood sugar well (HbA1c >=8%). Participants must speak English, be willing to use a home monitoring system for a year, and have access to phone or internet. It's not open to those with life expectancies under 18 months, other diabetes trial participants, significant dementia, substance abuse issues, or acute mental disorders.

Inclusion Criteria

Ability to communicate in English

Subjects must have access to a landline, Ethernet or cellphone for FORA data uploads for the study period

I have type 2 diabetes with an HbA1c level of 8% or higher.

Exclusion Criteria

You are currently involved in other studies for diabetes.

You have serious memory and thinking problems that affect your daily life.

You are currently experiencing severe mental health issues or a sudden change in mental condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive nurse education, home telemonitoring, and structured financial incentives for 12 months

12 months

Visits at baseline, 3, 6, 9, and 12 months

Sustainability Follow-up

Participants are monitored for sustainability of intervention effects after financial incentives are withdrawn

6 months

Visit at 18 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Active Comparator
• FINANCE-DM

Trial Overview The FINANCE-DM study is testing if financial rewards can boost the effectiveness of nurse education and home telemonitoring in managing Type 2 Diabetes. Half the patients will receive money incentives on top of this care; the other half won't. Researchers want to see if these benefits last even after stopping the payments and if they work equally well across different racial groups.

How Is the Trial Designed?

Group I: FINANCE-DM Intervention Experimental Treatment 1 Intervention

The FINANCE-DM intervention is comprised of: 1) nurse education, 2) home telemonitoring, and 3) structured financial incentives.

Group II: TIDES Intervention Active Control 1 Intervention

Patients randomized to the active comparator group will be assigned the FORA 2-in-1 Telehealth System. A nurse educator will review the glucose and BP readings and use them to tailor and reinforce behavior change.

Who Is Running the Clinical Trial?

State University of New York at Buffalo

Lead Sponsor

Trials

279

Recruited

52,600+

Medical College of Wisconsin

Lead Sponsor

Trials

645

Recruited

1,180,000+

Published Research Related to This Trial

A pilot study involving 100 participants showed that nurse-led mindfulness-based stress reduction (MBSR) therapy significantly reduced diabetes distress and improved diabetes self-efficacy and self-management over 12 weeks compared to standard diabetes education.

The nurse-led MBSR therapy also led to a notable reduction in HbA1c levels, indicating potential improvements in blood sugar control, making it a feasible and effective intervention for people with type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a nurse-led mindfulness stress-reduction intervention on diabetes distress, diabetes self-management, and HbA1c levels among people with type 2 diabetes: A pilot randomized controlled trial. Guo, J., Wang, H., Ge, L., et al.[2022]

A low-dose mindfulness-based stress reduction (MBSR) intervention was successfully delivered to prediabetes and diabetes patients, showing feasibility in a clinical setting with a recruitment rate of 55.9% and an attrition rate of 26.3%.

Participants experienced significant improvements post-intervention, including a reduction in depression scores, increased engagement in flexibility exercises, and a decrease in glycosylated hemoglobin (HbA1c) levels, indicating potential benefits for both mental and physical health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A feasibility study on low-dose mindfulness-based stress reduction intervention among prediabetes and diabetes patients. Xia, T., Lopes, S., Chen, L., et al.[2022]

In a study with 38 participants, mindfulness-based stress reduction (MBSR) significantly decreased diabetes-related distress and improved glucose control, indicating its potential as an effective intervention for diabetes management.

Participants also experienced notable improvements in mental health factors such as depression, anxiety, and self-efficacy, suggesting that MBSR can enhance both diabetes management and overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reducing diabetes distress and improving self-management with mindfulness. Whitebird, RR., Kreitzer, MJ., Vazquez-Benitez, G., et al.[2022]

The Mindful Stress Reduction in Diabetes Education (Mind-STRIDE) program, a mindfulness-based intervention for veterans, showed high satisfaction rates among participants and educators, with 71% of veterans completing the study.

Participants experienced significant improvements in diabetes-related outcomes, including reduced diabetes distress and better self-management behaviors, suggesting that mindfulness practices can positively impact diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Mindful Approach to Diabetes Self-Management Education and Support for Veterans. DiNardo, M., Saba, S., Greco, CM., et al.[2022]

In a study of 56 adults with diabetes, no significant differences were found in stress response, glycemic control, or vascular inflammation among those participating in Korean mindfulness-based stress reduction (K-MBSR), walking, or patient education.

However, both the K-MBSR and walking groups showed significant reductions in serum cortisol and PAI-1 levels, indicating potential benefits in stress hormone regulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of the effects of Korean mindfulness-based stress reduction, walking, and patient education in diabetes mellitus. Jung, HY., Lee, H., Park, J.[2015]

In a study involving 144 patients with bipolar disorder undergoing Mindfulness-Based Cognitive Therapy (MBCT), adverse effects (AEs) were reported by 29 patients, with most occurring within the first three weeks and decreasing thereafter.

Despite the occurrence of AEs, most patients viewed them as part of a therapeutic process rather than harmful, indicating that while AEs are present, they are generally not serious and can be perceived positively in the context of treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse or therapeutic? A mixed-methods study investigating adverse effects of Mindfulness-Based Cognitive Therapy in bipolar disorder. Hanssen, I., Scheepbouwer, V., Huijbers, M., et al.[2021]

Citations

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

Effectiveness of a nurse-led mindfulness stress-reduction intervention on diabetes distress, diabetes self-management, and HbA1c levels among people with type 2 diabetes: A pilot randomized controlled trial. [2022]

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

The Effects of Mindfulness-Based Interventions on Diabetes-Related Distress, Quality of Life, and Metabolic Control Among Persons with Diabetes: A Meta-Analytic Review. [2019]

3. Scotland pubmed.ncbi.nlm.nih.gov

A feasibility study on low-dose mindfulness-based stress reduction intervention among prediabetes and diabetes patients. [2022]

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

Reducing diabetes distress and improving self-management with mindfulness. [2022]

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

A Mindful Approach to Diabetes Self-Management Education and Support for Veterans. [2022]

6. Australia pubmed.ncbi.nlm.nih.gov

Comparison of the effects of Korean mindfulness-based stress reduction, walking, and patient education in diabetes mellitus. [2015]

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

Adverse or therapeutic? A mixed-methods study investigating adverse effects of Mindfulness-Based Cognitive Therapy in bipolar disorder. [2021]