Medicine, Medical College of Wisconsin, Milwaukee, Wisconsin, USA
Center for Advancing Population Science, Medical College of Wisconsin, Milwaukee, Wisconsin, USA.
BMJ Open. 2020 Dec 22;10(12):e043760. doi: 10.1136/bmjopen-2020-043760.
Given the burden of diabetes in ethnic minorities and emerging data on the efficacy of financial incentives in type 2 diabetes mellitus (T2DM), it is critical to examine the efficacy of financial incentives across and within racial/ethnic groups.
This trial is an ongoing 5-year, randomised clinical trial designed to test the efficacy of a inancial centives nd urse oaching to nhance Diabetes Outcomes (FINANCE-DM) intervention composed of (1) nurse education, (2) home telemonitoring and (3) structured financial incentives; compared with 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 The study also will evaluate whether intervention effects are sustained 6 months after the financial incentives are withdrawn (ie, 18 months post-randomisation) and whether the intervention is differentially efficacious across racial/ethnic groups. Participants will include 450 adults with a clinical diagnosis of T2DM and HbA1c of 8% or higher who self-identify as White, African American or Hispanic. Participants will be randomised to one of two groups: the FINANCE intervention or Active Control. The location and setting of this study include primary care clinics at the Medical College of Wisconsin (MCW) in Milwaukee, WI and community partner sites affiliated with the Center for Advancing Population Science at MCW.
This trial was approved by IRB at MCW under PRO00033788.
Registration for this trial on the United States National Institute of Health Clinical Trials Registry can be found under ID: NCT04203173 and online (https://clinicaltrials.gov/ct2/show/NCT04203173?id=NCT04203173&draw=2&rank=1).
鉴于少数民族糖尿病的负担以及 2 型糖尿病(T2DM)中经济激励措施的疗效的新数据,跨种族/族裔群体和同一群体内检验经济激励措施的疗效至关重要。
本试验是一项正在进行的为期 5 年的随机临床试验,旨在测试财务激励和护士辅导以改善糖尿病结局(FINANCE-DM)干预的疗效,该干预由(1)护士教育,(2)家庭远程监测和(3)结构化经济激励组成;与积极对照组(仅护士教育和家庭远程监测)进行比较。该研究还将评估在经济激励措施取消后(即随机分组后 18 个月)干预效果是否持续,以及干预措施是否在不同种族/族裔群体中具有不同的疗效。参与者将包括 450 名临床诊断为 T2DM 且 HbA1c 为 8%或更高的成年人,他们自认为是白人、非裔美国人或西班牙裔。参与者将随机分配到以下两组之一:FINANCE 干预组或积极对照组。该研究的地点和环境包括威斯康星州密尔沃基市医学科学院(MCW)的初级保健诊所以及与 MCW 人口科学推进中心相关联的社区合作伙伴站点。
该试验已获得 MCW 的 IRB 批准,PRO00033788 号。
可在美国国立卫生研究院临床试验注册处注册,注册号为 NCT04203173,网址为(https://clinicaltrials.gov/ct2/show/NCT04203173?id=NCT04203173&draw=2&rank=1)。