Preventing diabetes with digital health and coaching for translation and scalability (PREDICTS): A type 1 hybrid effectiveness-implementation trial protocol

被引：22

作者：

Almeida, Fabio A. ^{[1
,2
]}

Michaud, Tzeyu L. ^{[1
,2
]}

Wilson, Kathryn E. ^{[1
]}

Schwab, Robert J. ^{[3
]}

Goessl, Cody ^{[1
]}

Porter, Gwenndolyn C. ^{[1
]}

Brito, Fabiana A. ^{[1
]}

Evans, Greg ^{[4
]}

Dressler, Emily V. ^{[4
]}

Boggs, Ashley E. ^{[5
]}

Katula, Jeffrey A. ^{[5
]}

Sweet, Cynthia Castro ^{[6
]}

Estabrooks, Paul A. ^{[1
,2
]}

机构：

[1] Univ Nebraska, Med Ctr, Dept Hlth Promot, Omaha, NE 68198 USA

[2] Univ Nebraska, Med Ctr, Ctr Reducing Hlth Dispar, Omaha, NE 68198 USA

[3] Univ Nebraska, Med Ctr, Dept Internal Med, Omaha, NE 68198 USA

[4] Wake Forest Sch Med, Dept Biostat & Data Sci, Winston Salem, NC 27157 USA

[5] Wake Forest Univ, Dept Hlth & Exercise Sci, Winston Salem, NC 27109 USA

[6] Omada Hlth Inc, Med Affairs, San Francisco, CA 94111 USA

来源：

CONTEMPORARY CLINICAL TRIALS | 2020年 / 88卷

关键词：

Prediabetes; diabetes prevention; Hybrid effectiveness-implementation trial; RE-3AIM framework; LIFE-STYLE INTERVENTIONS; WEIGHT-LOSS; PROGRAM; SCALE; RISK; VALIDATION; GUIDELINE; ADHERENCE; EHEALTH; PEOPLE;

D O I：

10.1016/j.cct.2019.105877

中图分类号：

R-3 [医学研究方法]; R3 [基础医学];

学科分类号：

1001 ;

摘要：

Background: 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. Purpose: 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-MM frameworks. Methods: 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. Conclusion: This trial of a digital DPP will allow the research team to determine the relationships between reach, effectiveness, implementation, and costs.

引用

页数：9

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