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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 Medical College of Wisconsin

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

FINANCE-DM Trial 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 The study will also evaluate whether intervention effects are sustained 6 months after the financial incentives are withdrawn (i.e. 18 months post randomization); and whether the intervention is differentially efficacious across racial/ethnic groups.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.Check my eligibility

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.See study design

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.

FINANCE-DM Trial 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.

FINANCE-DM Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Glycemic control (HbA1c)

Resource Utilization and Cost

Secondary outcome measures

LDL-Cholesterol

Quality of Life as measured by SF-12

Self-Care Behavior

+2 more

FINANCE-DM 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

Find a Location

Who is running the clinical trial?

Medical College of WisconsinLead Sponsor

609 Previous Clinical Trials

1,162,151 Total Patients Enrolled

Leonard E Egede, MD, MSPrincipal InvestigatorMedical College of Wisconsin

6 Previous Clinical Trials

859 Total Patients Enrolled

Media Library

Active Comparator Clinical Trial Eligibility Overview. Trial Name: NCT04203173 — N/A

Type 2 Diabetes Research Study Groups: FINANCE-DM Intervention, TIDES Intervention

Type 2 Diabetes Clinical Trial 2023: Active Comparator Highlights & Side Effects. Trial Name: NCT04203173 — N/A

Active Comparator 2023 Treatment Timeline for Medical Study. Trial Name: NCT04203173 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any current opportunities for participants to join this research?

"According to clinicaltrials.gov, this research study is still in the recruitment phase. It was initially posted on December 1st 2019 and has been amended as recently as February 7th 2022."

Answered by AI

How many participants are taking part in this research?

"Correct. The data hosted on clinicaltrials.gov affirms that this experiment, which was first available for view on December 1st 2019, is currently accepting volunteers. Approximately 450 individuals need to be enrolled from a single medical institution."

Answered by AI

What is the desired result from this clinical investigation?

"This medical trial intends to assess Change from baseline HbA1c at 12 months post intervention follow-ups, Resource Utilization and Cost. Secondary outcomes include LDL-Cholesterol (which will be determined via 10cc of blood drawn by trained phlebotomists), Systolic and Diastolic Blood Pressure (readings obtained using an automated BP monitor) as well as Self-Care Behavior Brooks Medication Adherence Scale (BMAS)."

Answered by AI

Recent research and studies

BMJ OpenJournal

Financial Incentives and Nurse Coaching to Enhance Diabetes Outcomes (FINANCE-DM): A Trial Protocol

Egede, Leonard E, Rebekah Walker, Joni S Williams, Rebecca Knapp, Clara Elizabeth Dismuke, Tatiana Davidson, and Jennifer A Campbell. 2020. “Financial Incentives and Nurse Coaching to Enhance Diabetes Outcomes (FINANCE-DM): A Trial Protocol”. BMJ Open. BMJ. doi:10.1136/bmjopen-2020-043760.

clinicaltrials.govStudy

Financial Incentives And Nurse Coaching to Enhance Diabetes Outcomes (FINANCE-DM)-1

Egede, Leonard E 2019. "Financial Incentives And Nurse Coaching to Enhance Diabetes Outcomes (FINANCE-DM)-1". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04203173.