Financial Incentives And Nurse Coaching to Enhance Diabetes Outcomes - FINANCE-DM
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 450
- 试验地点
- 2
- 主要终点
- Glycemic control (HbA1c)
研究概览
简要总结
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control long term? 2) Are the effects of financial incentives on metabolic control sustained once the incentives are withdrawn?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 The study also will evaluate whether intervention effects are sustained 6 months after the financial incentives are withdrawn (i.e. 18 months post randomization); and whether the intervention is differentially efficacious across racial/ethnic groups.
详细描述
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 The study also will evaluate whether intervention effects are sustained 6 months after the financial incentives are withdrawn (i.e. 18 months post randomization); and whether the intervention is differentially efficacious across racial/ethnic groups.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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
FINANCE-DM Intervention
The FINANCE-DM intervention is comprised of: 1) nurse education, 2) home telemonitoring, and 3) structured financial incentives.
干预措施: FINANCE-DM (Behavioral)
TIDES 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.
干预措施: Active Comparator (Behavioral)
结局指标
主要结局
Glycemic control (HbA1c)
时间窗: Change from baseline HbA1c at 12 months post intervention follow-ups
Blood specimens (10cc of blood) will be obtained by trained phlebotomists or nurse for HbA1c.
Resource Utilization and Cost
时间窗: Change from baseline resource utilization and cost at at 12 months post-intervention follow-ups
Previously validated questions on resource utilization will be administered. The questionnaires capture information on hospitalizations, physician/professional visits, and medications.
Glycemic Control (HbA1c)
时间窗: HbA1c at 12 months follow-up
Blood specimens (10cc of blood) will be obtained by trained phlebotomists or nurse for HbA1c.
次要结局
- 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)
- Self-Care Behavior(Change from baseline self-care 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 Brooks Medication Adherence Scale (BMAS)(Change from baseline self-care at at 12 months post intervention follow-ups)
- Glycemic Control (HbA1c)(HbA1c at 18 months follow-up)
研究者
Leonard Ehianu Egede
Professor & Chair, Department of Medicine
State University of New York at Buffalo