Financial Incentives And Nurse Coaching to Enhance Diabetes Outcomes (FINANCE-DM)-1 (NCT04203173) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Financial Incentives And Nurse Coaching to Enhance Diabetes Outcomes (FINANCE-DM)-1
United States450 participantsStarted 2019-12-01
Plain-language 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control long term? 2) Are the effects of financial incentives on metabolic control sustained once the incentives are withdrawn?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 The study also will evaluate whether intervention effects are sustained 6 months after the financial incentives are withdrawn (i.e. 18 months post randomization); and whether the intervention is differentially efficacious across racial/ethnic groups.
Who can participate
Age range
21 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Exclusion criteria
. Mental confusion on interview suggesting significant dementia;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial combines financial incentives with nurse coaching to manage Type 2 diabetes — can you help me understand how the nurse coaching component would actually work in practice, and whether that kind of support would realistically fit into my schedule and current care routine?
2Since this trial is no longer actively recruiting, are there similar studies or programs combining financial incentives and structured coaching for diabetes management that I might still be able to join?
3This study is measuring both blood sugar control (HbA1c) and healthcare resource use and costs — what does that tell us about what the researchers are trying to learn, and does it mean the focus might be as much on cost savings as on improving my health outcomes?
4Because this trial is listed as Phase NA, it may not be testing a new drug but rather a care approach — how does that affect what's already known about the safety and effectiveness of this kind of financial incentive and coaching program for Type 2 diabetes?
5Before considering a trial like this, would you recommend I first explore whether standard diabetes care options — like existing diabetes education programs or medication adjustments — might achieve similar improvements in my HbA1c without the added demands of participating in a study?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Glycemic control (HbA1c)
Timeframe: Change from baseline HbA1c at 12 months post intervention follow-ups
2
Resource Utilization and Cost
Timeframe: Change from baseline resource utilization and cost at at 12 months post-intervention follow-ups