Clinical trial NCT04203173: Financial Incentives And Nurse Coaching to Enhance Diabetes Outcomes (FINANCE-DM)-1
Official title: Financial Incentives And Nurse Coaching to Enhance Diabetes Outcomes - FINANCE-DM
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Type 2 Diabetes
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
First posted: 2019-12-18
Enrollment: 450
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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control long term? 2) Are the effects of financial incentives on metabolic control sustained once the incentives are withdrawn?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 The study also will evaluate whether intervention effects are sustained 6 months after the financial incentives are withdrawn (i.e. 18 months post randomization); and whether the intervention is differentially efficacious across racial/ethnic groups.

Detailed description: Study Overview. The overarching aim of this proposal is to test the efficacy of structured financial incentives intervention (FINANCE-DM) 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) on glycemic control. The study also will evaluate whether intervention effects are sustained 6 months after the financial incentives are withdrawn (i.e. 18 months post randomization); and whether the intervention is differentially efficacious across racial/ethnic groups. Equal number of patients from three racial/ethnic groups (150 Whites, 150 AAs and 150 HAs, total sample of 450) will be randomized to FINANCE-DM intervention (n=225) or an active comparator group (n=225), so that within each racial/ethnic group, half (75 patients) will be randomized to the FINANCE-DM intervention group and the other half (75 patients) will be randomized to the active comparator group. Primary aims are to test overall efficacy across combined racial/ethnic groups; efficacy within racial/ethnic groups and cost effectiveness for the primary endpoint (glycemic control). Secondary aim is to test efficacy on secondary endpoints including BP, LDL, QOL and self-care behaviors. Each patient will be followed for 12 months (long-term effect) and 18 months (sustainability effect), with study visits at baseline, 3, 6, 9, 12 and 18 months. The FINANCE-DM intervention is comprised of: 1) nurse education, 2) home telemonitoring, and 3) structured financial incentives. The active comparator group will receive the same nurse education and home telemonitoring intervention as the FINANCE-DM group, on the same schedule, and for the same duration . The only difference is that participants will not receive structured financial incentives.

Eligibility criteria: Inclusion Criteria:

1. Age \>=21 years;
2. Clinical diagnosis of T2DM and HbA1c \>=8% at the screening visit;
3. Self-identified as White, AA or HA;
4. Subject must be willing to use the FORA monitoring system for 12 months;
5. 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.

Exclusion Criteria:

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

Primary outcomes:
measure: Glycemic control (HbA1c)
timeFrame: Change from baseline HbA1c at 12 months post intervention follow-ups
measure: Resource Utilization and Cost
timeFrame: Change from baseline resource utilization and cost at at 12 months post-intervention follow-ups
Secondary outcomes:
measure: LDL-Cholesterol
timeFrame: Change from baseline cholesterol at at 12 months post intervention follow-ups
measure: Quality of Life as measured by SF-12
timeFrame: Change from baseline quality of life measure at at 12 months post intervention follow-ups
measure: Systolic and Diastolic Blood Pressure
timeFrame: Change from baseline blood pressure at at 12 months post intervention follow-ups
measure: Self-Care Behavior
timeFrame: Change from baseline self-care at at 12 months post intervention follow-ups
measure: Self-Care Behavior Brooks Medication Adherence Scale (BMAS)
timeFrame: Change from baseline self-care at at 12 months post intervention follow-ups
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: Leonard E Egede, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.