Miyamoto Sheridan, Dharmar Madan, Fazio Sarina, Tang-Feldman Yajarayma, Young Heather M
College of Nursing, The Pennsylvania State University, University Park, PA, United States.
Department of Pediatrics, University of California Davis, Sacramento, CA, United States.
JMIR Res Protoc. 2018 Feb 15;7(2):e45. doi: 10.2196/resprot.9168.
Chronic diseases, including diabetes mellitus, are the leading cause of mortality and disability in the United States. Current solutions focus primarily on diagnosis and pharmacological treatment, yet there is increasing evidence that patient-centered models of care are more successful in improving and addressing chronic disease outcomes.
The objective of this clinical trial is to evaluate the impact of a mobile health (mHealth) enabled nurse health coaching intervention on self-efficacy among adults with type-2 diabetes mellitus.
A randomized controlled trial was conducted at an academic health system in Northern California. A total of 300 participants with type-2 diabetes were scheduled to be enrolled through three primary care clinics. Participants were randomized to either usual care or intervention. All participants received training on use of the health system patient portal. Participants in the intervention arm received six scheduled health-coaching telephone calls with a registered nurse and were provided with an activity tracker and mobile application that integrated data into the electronic health record (EHR) to track their daily activity and health behavior decisions. All participants completed a baseline survey and follow-up surveys at 3 and 9 months. Primary and secondary outcomes include diabetes self-efficacy, hemoglobin A (HbA), and quality of life measures.
Data collection for this trial, funded by the Patient-Centered Outcomes Research Institute, will be completed by December 2017. Results from the trial will be available mid-2018.
This protocol details a patient-centered intervention using nurse health coaching, mHealth technologies, and integration of patient-generated data into the EHR. The aim of the intervention is to enhance self-efficacy and health outcomes by providing participants with a mechanism to track daily activity by offering coaching support to set reasonable and attainable health goals, and by creating a complete feedback loop by bringing patient-generated data into the EHR.
ClinicalTrials.gov NCT02672176; https://clinicaltrials.gov/ct2/show/NCT02672176 (Archived by WebCite at http://www.webcitation.org/6xEQXe1M5).
包括糖尿病在内的慢性病是美国死亡和残疾的主要原因。目前的解决方案主要集中在诊断和药物治疗上，但越来越多的证据表明，以患者为中心的护理模式在改善和解决慢性病结果方面更成功。
本临床试验的目的是评估移动健康（mHealth）支持的护士健康指导干预对2型糖尿病成年人自我效能的影响。
在北加利福尼亚的一个学术健康系统中进行了一项随机对照试验。共有300名2型糖尿病参与者计划通过三个初级保健诊所招募。参与者被随机分为常规护理组或干预组。所有参与者都接受了使用健康系统患者门户的培训。干预组的参与者与一名注册护士进行了六次预定的健康指导电话，并获得了一个活动追踪器和移动应用程序，该应用程序将数据集成到电子健康记录（EHR）中，以追踪他们的日常活动和健康行为决策。所有参与者在基线时以及3个月和9个月时完成了调查。主要和次要结果包括糖尿病自我效能、糖化血红蛋白（HbA）和生活质量指标。
由患者为中心的结果研究所资助的这项试验的数据收集将于2017年12月完成。试验结果将于2018年年中公布。
本方案详细介绍了一种以患者为中心的干预措施，使用护士健康指导、mHealth技术以及将患者生成的数据集成到EHR中。干预的目的是通过为参与者提供一种追踪日常活动的机制，提供指导支持以设定合理且可实现的健康目标，并通过将患者生成的数据纳入EHR创建一个完整的反馈循环，从而提高自我效能和健康结果。
ClinicalTrials.gov NCT02672176；https://clinicaltrials.gov/ct2/show/NCT02672176（由WebCite存档于http://www.webcitation.org/6xEQXe1M5）。
