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

NCT04203173

CompletedNA

Sponsor: State University of New York at Buffalo

Conditions: Type 2 Diabetes

Interventions: FINANCE-DM, Active Comparator

Countries: United States

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control long term? 2) Are the effects of financial incentives on metabolic control sustained once the incentives are withdrawn?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 The study also will evaluate whether intervention effects are sustained 6 months after the financial incentives are withdrawn (i.e. 18 months post randomization); and whether the intervention is differentially efficacious across racial/ethnic groups.

Eligibility overview

Sex: ALL

Age: 21 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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.

Locations (1)

Buffalo, New York, United States