Ferkauf Graduate School of Psychology, Yeshiva University, Bronx, NY, USA; Departments of Medicine (Endocrinology) and Epidemiology & Population Health, Albert Einstein College of Medicine, Bronx, NY, USA; The Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine, Bronx, NY, USA.
Ferkauf Graduate School of Psychology, Yeshiva University, Bronx, NY, USA.
Contemp Clin Trials. 2020 Nov;98:106166. doi: 10.1016/j.cct.2020.106166. Epub 2020 Oct 3.
Although problems with type 2 diabetes (T2D) self-management and treatment adherence often co-occur with emotional distress, few translatable intervention approaches are available that can target these related problems in primary care practice settings. The New York City (NYC) Care Calls study is a randomized controlled trial that tests the effectiveness of structured support for diabetes self-management and distress management, delivered via telephone by health educators, in improving glycemic control, self-management and emotional well-being among predominantly ethnic minority and socioeconomically disadvantaged adults with suboptimally controlled T2D. English- and Spanish-speaking adults treated for T2D in NYC primary care practices were recruited based on having an A1C ≥ 7.5% despite being prescribed medications for diabetes. Participants (N = 812) were randomly assigned to a telephonic intervention condition with a stepped protocol of 6-12 phone calls over 1 year, delivered by a health educator, or to a comparison condition of enhanced usual care. The primary outcome is change in A1C over one year, measured at baseline and again approximately 6- and 12-months later. Secondary outcomes measured on the same schedule include blood pressure, patient-reported emotional distress, treatment adherence and self-management behaviors. A comprehensive effectiveness evaluation is guided by the RE-AIM framework (Reach, Effectiveness, Adoption, Implementation, Maintenance) to gather data that can inform dissemination and implementation of the intervention, if successful. This paper describes the study rationale, trial design, and methodology.
尽管 2 型糖尿病（T2D）自我管理和治疗依从性方面的问题通常与情绪困扰同时发生，但在初级保健实践环境中，很少有可转化的干预方法可以针对这些相关问题。纽约市（NYC）关怀电话研究是一项随机对照试验，旨在测试通过健康教育者通过电话提供结构化的糖尿病自我管理和压力管理支持，以改善血糖控制、自我管理和情绪健康的有效性，研究对象是主要为少数民族和社会经济处于不利地位、血糖控制不理想的 T2D 成年人。根据 A1C≥7.5%（尽管开了糖尿病药物），在纽约市初级保健诊所接受 T2D 治疗的英语和西班牙语成年人被招募参与该研究。参与者（N=812）被随机分配到电话干预组，干预组采用 6-12 次电话的逐步方案，每次电话由一名健康教育者进行，或分配到增强的常规护理对照组。主要结果是一年中 A1C 的变化，在基线和大约 6 个月和 12 个月后进行测量。在相同时间间隔测量的次要结果包括血压、患者报告的情绪困扰、治疗依从性和自我管理行为。综合有效性评估受 RE-AIM 框架（Reach、Effectiveness、Adoption、Implementation、Maintenance）指导，以收集数据，如果干预成功，可以为其传播和实施提供信息。本文描述了研究的基本原理、试验设计和方法。
