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

NCT04203173 | Active Not Recruiting DMC

• 1 other identifier: 1R01DK120861
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 1

Brief Summary

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control long term? 2) Are the effects of financial incentives on metabolic control sustained once the incentives are withdrawn?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 The study also will evaluate whether intervention effects are sustained 6 months after the financial incentives are withdrawn (i.e. 18 months post randomization); and whether the intervention is differentially efficacious across racial/ethnic groups.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (2)

• Glycemic control (HbA1c)

  Blood specimens (10cc of blood) will be obtained by trained phlebotomists or nurse for HbA1c.

  Change from baseline HbA1c at 12 months post intervention follow-ups

• Resource Utilization and Cost

  Previously validated questions on resource utilization will be administered. The questionnaires capture information on hospitalizations, physician/professional visits, and medications.

  Change from baseline resource utilization and cost at at 12 months post-intervention follow-ups

Secondary Outcomes (5)

• LDL-Cholesterol

  Change from baseline cholesterol at at 12 months post intervention follow-ups

• Quality of Life as measured by SF-12

  Change from baseline quality of life measure at at 12 months post intervention follow-ups

• Systolic and Diastolic Blood Pressure

  Change from baseline blood pressure at at 12 months post intervention follow-ups

• Self-Care Behavior

  Change from baseline self-care at at 12 months post intervention follow-ups

• Self-Care Behavior Brooks Medication Adherence Scale (BMAS)

  Change from baseline self-care at at 12 months post intervention follow-ups

Study Arms (2)

FINANCE-DM Intervention

EXPERIMENTAL

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

Behavioral: FINANCE-DM

TIDES Intervention

ACTIVE COMPARATOR

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.

Behavioral: Active Comparator

Interventions

FINANCE-DM BEHAVIORAL

The FINANCE-DM intervention is comprised of: 1) nurse education, 2) home telemonitoring, and 3) structured financial incentives. Patients randomized to FINANCE-DM will be assigned the FORA 2-in-1 Telehealth System and provided glucose test strips to allow testing at least once a day. BG and BP will be measured daily and results will be uploaded to a secure server. A nurse educator will review the glucose and BP readings and use them to tailor and reinforce behavior change during weekly telephone-delivered diabetes education and skills training session. Participants will also receive financial rewards for: 1) uploading glucose measurements; 2) participating in telephone delivered educational sessions; and 3) absolute percentage drops in HbA1c from baseline at each 3-month follow-up intervals.

FINANCE-DM Intervention

Active Comparator BEHAVIORAL

Patients randomized to the active comparator group will be assigned the FORA 2-in-1 Telehealth System and provided glucose test strips to allow testing at least once a day. BG and BP will be measured daily and results will be uploaded to a secure server. A nurse educator will review the glucose and BP readings and use them to tailor and reinforce behavior change during weekly telephone-delivered diabetes education and skills training session.

TIDES Intervention

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>=21 years;
• Clinical diagnosis of T2DM and HbA1c \>=8% at the screening visit;
• Self-identified as White, AA or HA;
• Subject must be willing to use the FORA monitoring system for 12 months;
• Subjects must have access to a landline, Ethernet or cellphone for FORA data uploads for the study period; and 6) Ability to communicate in English.

You may not qualify if:

• Mental confusion on interview suggesting significant dementia;
• Participation in other diabetes clinical trials;
• Alcohol or drug abuse/dependency;
• Active psychosis or acute mental disorder; and
• Life expectancy \<18 months.

Sponsors & Collaborators

• State University of New York at Buffalo: lead

Study Sites (1)

State University of New York at Buffalo

Buffalo, New York, 14203, United States

Location

Related Publications (1)

• Egede LE, Walker R, Williams JS, Knapp R, Dismuke CE, Davidson T, Campbell JA. Financial Incentives and Nurse Coaching to Enhance Diabetes Outcomes (FINANCE-DM): a trial protocol. BMJ Open. 2020 Dec 22;10(12):e043760. doi: 10.1136/bmjopen-2020-043760.

  PMID: 33371048 BACKGROUND

Related Links

• PDF of study protocol paper

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Leonard E Egede, MD, MS

  State University of New York at Buffalo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor & Chair, Department of Medicine

Study Record Dates

• First Submitted: November 26, 2019
• First Posted: December 18, 2019
• Study Start: December 1, 2019
• Primary Completion: June 30, 2025
• Study Completion: March 31, 2026
• Last Updated: August 6, 2025

Record last verified: 2025-08

Locations

US (1)