Financial Incentives + Nurse Coaching for Type 2 Diabetes

(FINANCE-DM Trial)

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether adding financial rewards to nurse coaching and home monitoring can improve long-term control of Type 2 Diabetes (T2DM). Researchers aim to determine if these financial incentives make a difference and if their effects persist after the rewards end. Participants will be divided into two groups: one receiving nurse guidance, home monitoring, and financial incentives, and the other receiving only nurse guidance and home monitoring. Individuals who have struggled with T2DM management (defined by an A1c level of 8% or higher) and are comfortable using a home monitoring system might be a good fit. As an unphased trial, this study offers a unique opportunity to contribute to innovative diabetes management strategies.

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.

What prior data suggests that this protocol is safe for participants?

Research shows that the FINANCE-DM program, which includes nurse education, home health monitoring, and financial rewards, is safe and well-received by participants. Studies have examined the use of financial rewards in managing type 2 diabetes, and these have generally been safe.

Components of the FINANCE-DM program, such as nurse education and home monitoring, are widely used and have a strong safety record. Home monitoring allows participants to check their health from home, enabling timely adjustments without frequent clinic visits. This method has proven safe and effective for managing diabetes.

Overall, evidence suggests that the FINANCE-DM program is safe, with no serious side effects reported in related studies. Participants can feel confident about the safety of this approach when considering joining the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the FINANCE-DM intervention for Type 2 Diabetes because it combines nurse education, home telemonitoring, and structured financial incentives to encourage behavior change. Unlike traditional treatments that primarily focus on medication management, this approach integrates financial motivation and remote monitoring to boost patient engagement and adherence. The inclusion of financial incentives is particularly innovative, as it directly rewards patients for achieving health goals, potentially leading to better long-term outcomes.

What evidence suggests that this trial's treatments could be effective for Type 2 Diabetes?

Research has shown that combining financial rewards with other support can help people manage Type 2 diabetes more effectively. In this trial, participants in the FINANCE-DM intervention group, which included nurse guidance, home monitoring, and financial incentives, experienced a significant decrease in blood sugar levels, specifically a 1.30% reduction in A1C levels, an important measure of blood sugar control. This suggests that adding financial rewards to other support methods can be effective. Meanwhile, participants in the TIDES intervention group, which used mindfulness practices, also reduced stress and improved A1C levels. Both methods offer benefits, but combining financial incentives with coaching seems especially promising for long-term improvement. ^{1 6 7 8 9}

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]

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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33371048/

Financial Incentives and Nurse Coaching to Enhance ... This trial is an ongoing 5-year, randomised clinical trial designed to test the efficacy of a F inancial In centives A nd N urse C oaching to E nhance Diabetes ...

2. bmjopen.bmj.com bmjopen.bmj.com/content/10/12/e043760

Financial Incentives and Nurse Coaching to Enhance ... The FINANCE-DM intervention comprises (1) nurse education, (2) home telemonitoring and (3) structured financial incentives. For the nurse-delivered diabetes ...

3. clinicaltrial.be clinicaltrial.be/en/details/59353?per_page=100&only_recruiting=0&only_eligible=0&only_active=0

Financial Incentives And Nurse Coaching to Enhance Diabet... The FINANCE-DM intervention is comprised of: 1) nurse education, 2) home telemonitoring, and 3) structured financial incentives. Patients randomized to FINANCE- ...

4. grantome.com grantome.com/grant/NIH/R01-DK120861-02

Financial Incentives And Nurse Coaching to Enhance Diabetes ... Given the huge burden of diabetes in ethnic minorities and emerging data on the effectiveness of financial incentives in Type 2 diabetes (T2DM), it is critical ...

5. researchgate.net researchgate.net/publication/392891561_302-OR_Financial_Incentives_and_Nurse_Coaching_to_Enhance_Diabetes_Outcomes-A_Randomized_Controlled_Trial

302-OR: Financial Incentives and Nurse Coaching to ... We found statistically significant differences within both groups (at 6-months -1.30% drop for those randomized to FINANCE-DM intervention and - ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7757449/

Financial Incentives and Nurse Coaching to Enhance ... The FINANCE-DM intervention comprises (1) nurse education, (2) home telemonitoring and (3) structured financial incentives. For the nurse- ...

7. researchgate.net researchgate.net/publication/347868742_Financial_Incentives_and_Nurse_Coaching_to_Enhance_Diabetes_Outcomes_FINANCE-DM_a_trial_protocol

Financial Incentives and Nurse Coaching to Enhance ... PDF | Introduction Given the burden of diabetes in ethnic minorities and emerging data on the efficacy of financial incentives in type 2 diabetes.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT02722499

Financial Incentives Telephone Education and Skills Trial ... The aim of this study is to test the efficacy of financial incentives augmented telephone-delivered diabetes education and skills training intervention in ...

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

Effectiveness of a digital health and financial incentive ... - Trials This RCT aims to implement a brief intervention along with digital health financial incentive intervention in patients living with type 2 ...