Department of Health Promotion, University of Nebraska Medical Center, Omaha, NE 68198, United States; Center for Reducing Health Disparities, University of Nebraska Medical Center, Omaha, NE 68198, United States.
Department of Health Promotion, University of Nebraska Medical Center, Omaha, NE 68198, United States.
Contemp Clin Trials. 2020 Jan;88:105877. doi: 10.1016/j.cct.2019.105877. Epub 2019 Nov 1.
Diabetes prevention remains a top public health priority; digital approaches are potential solutions to existing scalability and accessibility challenges. There remains a gap in our understanding of the relationship between effectiveness, costs, and potential for sustained implementation of digital diabetes prevention strategies within typical healthcare settings.
To describe the methods and design of a type 1 hybrid effectiveness-implementation trial of a digital diabetes prevention program (DPP) using the iPARIHS and RE-AIM frameworks.
The trial will contrast the effects of two DPP interventions: (1) small group, in-person class, and (2) a digital DPP consisting of small group support, personalized health coaching, digital tracking tools, and weekly behavior change curriculum. Each intervention includes personal action planning with a focus on key elements of the lifestyle intervention from the CDC National DPP. Adults at risk for diabetes (BMI ≥25 and 5.7% ≤ HbA1c ≤ 6.4) will be randomly assigned to either the intervention group (n = 241) or the small group (n = 241). Assessment of primary (HbA1c) and secondary (weight loss, costs, cardiovascular risk factors) outcomes will occur at baseline, 4, and 12 months. Additionally, the trial will explore the potential for future adoption, implementation, and sustainability of the digitally-based intervention within a regional healthcare system based on key informant interviews and assessments of organizational administrators and primary care physicians.
This trial of a digital DPP will allow the research team to determine the relationships between reach, effectiveness, implementation, and costs.
糖尿病预防仍然是公共卫生的首要任务；数字方法是解决现有可扩展性和可及性挑战的潜在解决方案。我们对数字糖尿病预防策略在典型医疗保健环境中的有效性、成本和持续实施潜力之间的关系的理解仍存在差距。
描述使用 iPARIHS 和 RE-AIM 框架对数字糖尿病预防计划 (DPP) 的 1 型混合有效性实施试验的方法和设计。
该试验将对比两种 DPP 干预措施的效果：（1）小组、面对面课程，（2）由小组支持、个性化健康指导、数字跟踪工具和每周行为改变课程组成的数字 DPP。每个干预措施都包括个人行动计划，重点是 CDC 国家 DPP 中生活方式干预的关键要素。有糖尿病风险的成年人（BMI≥25 和 5.7%≤HbA1c≤6.4）将被随机分配到干预组（n=241）或小组组（n=241）。主要（HbA1c）和次要（体重减轻、成本、心血管风险因素）结果的评估将在基线、4 个月和 12 个月进行。此外，该试验将通过关键知情人访谈和对组织管理员和初级保健医生的评估，探索基于数字的干预措施在区域医疗保健系统中的未来采用、实施和可持续性的潜力。
该数字 DPP 试验将使研究团队能够确定可及性、有效性、实施和成本之间的关系。
