Nudging people with Type 2 diabetes towards sustained adherence to self-management: a cluster randomized controlled trial

--这项研究旨在评估为改善成人2型糖尿病患者的自我管理行为而开发的个性化行为干预(‘反馈’)的效果。反馈是一种资源最小化的干预措施，旨在由全科医生(GP)在常规初级保健环境中提供。这项研究是一项整群随机对照试验(RCT)，随访6个月。-在日本，初级保健政策的实施才刚刚开始，有必要在全国范围内将以证据为基础、以人为中心的糖尿病护理引入全科医生的实践。如果我们能够将我们的反馈干预与改善患者结局和初级保健提供联系起来，这将为日本加强初级保健服务和初级保健投资提供进一步的理由。2022年：-在2020年和2021年由于新冠肺炎疫情而遇到许多研究实施挑战和延误之后，我们现在设法在招募过程中取得了良好的进展。到目前为止，已经招募了18家全科医生，这接近我们最初的样本量目标(n=20)。我们想再招募几个实践，以确保我们预先登记的感兴趣的最小影响大小可以被检测到。-由于我们在招募过程中取得了良好的进展，我们于2023年1月将研究方案提交给了一份国际同行评议期刊发表。这份手稿已被接受在《试验》杂志上发表。

- The study aims to evaluate the effects of a personalized behavioral intervention (‘FEEDBACK’) developed to improve self-management behavior in adults with type 2 diabetes. FEEDBACK is a resource-minimizing intervention designed to be delivered by general practitioners (GPs) in routine primary care settings. The study is a cluster randomized controlled trial (RCT) with six months follow-up.- In Japan, where the implementation of primary care policy has just begun, it is necessary to introduce evidence-based, person-centered diabetic care into the practice of GPs nationwide. If we could link our FEEDBACK intervention with improved patient outcomes and delivery in primary care, this would provide further justification for stronger primary care services and investment in primary care in Japan.2022:- After numerous study implementation challenges and delays encountered in 2020 and 2021 due to the COVID-19 pandemic, we have now managed to make good progress in the recruitment process. Eighteen GP practices have been recruited so far, which is close to our initial sample size objective (n=20). We would like to recruit a few more practices to ensure that our pre-registered minimum effect size of interest can be detectable.- As we made good process on the recruitment process, we submitted the study protocol for publication in an international peer-reviewed journal in January 2023. The manuscript has been accepted for publication in the journal 'Trials'.