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Financial Incentives + Nurse Coaching for Type 2 Diabetes (FINANCE-DM Trial)

N/A

Waitlist Available

Led By Leonard E Egede, MD, MS

Research Sponsored by State University of New York at Buffalo

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Clinical diagnosis of T2DM and HbA1c >=8% at the screening visit

Age >=21 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline self-care at at 12 months post intervention follow-ups

Awards & highlights

No Placebo-Only Group

Summary

This trial will test the efficacy of a financial incentive intervention for adults with poorly controlled type 2 diabetes. The intervention will be compared to an active control group (nurse education and home telemonitoring alone). The study will also evaluate whether intervention effects are sustained 6 months after the financial incentives are withdrawn (i.e. 18 months post randomization); and whether the intervention is differentially efficacious across racial/ethnic groups.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves educational support and financial incentives rather than medication or medical procedures, traditional side effects are not expected. However, there may be indirect effects related to stress or behavior changes due to participation in the study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am 21 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline quality of life measure at at 12 months post intervention follow-ups

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline quality of life measure at at 12 months post intervention follow-ups

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline quality of life measure at at 12 months post intervention follow-ups for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Glycemic control (HbA1c)

Resource Utilization and Cost

Secondary study objectives

LDL-Cholesterol

Quality of Life as measured by SF-12

Self-Care Behavior

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: FINANCE-DM InterventionExperimental Treatment1 Intervention

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

Group II: TIDES InterventionActive Control1 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.

0 / 2Eligibility criteria met