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临床试验/NCT03403231
NCT03403231已完成不适用

INcreasing Veteran EngagemeNT to Prevent Diabetes (INVENT) (CDA 13-267)

VA Office of Research and Development2 个研究点 分布在 1 个国家目标入组 144 人开始时间: 2018年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
144
试验地点
2
主要终点
Engagement in Recommended Behaviors to Prevent Type 2 Diabetes

研究概览

简要总结

This study will evaluate a VA MyHealtheVet Secure Messaging intervention that uses different intervention messaging strategies designed to increase engagement in behaviors to prevent type 2 diabetes.

The investigators will enroll 144 eligible Veterans into a 12-week MyHealtheVet Secure Messaging intervention. Eligible Veterans include those who are currently using MyHealtheVet secure messaging, meet inclusion/exclusion criteria, and have received an HbA1c test within the last 6 months that meets the ADA/CDC classification for prediabetes. Study participants will be surveyed about their engagement in behaviors to prevent TDM2 and mediators of this engagement. After completing a baseline survey, participants will be randomly assigned to receive different novel presentations of information about ways to prevent T2DM through both Secure Messaging and US Mail. The investigators will test the 5 presentations that each: (1) represent an innovative approach from behavioral economics or health psychology with great promise to increase engagement in behaviors to prevent T2DM among patients with prediabetes; and (2) have not been tested in this setting.

详细描述

There is tremendous national enthusiasm for translating and disseminating efficacious strategies to prevent type 2 diabetes mellitus (T2DM). Yet, little attention has been devoted to how the investigators can better leverage the processes through which patients receive information about prevention of T2DM to better engage them in such prevention. Further, despite efforts to disseminate structured programs, many patients at high risk for developing T2DM may still be unable or unwilling to access them. In these cases, increasing patient engagement in individually directed lifestyle change or pharmacotherapy is critical. Strategies developed in the fields of behavioral economics and health psychology hold significant promise for improving Veteran engagement in each of these approaches. To date, however, these strategies have rarely been translated into real-world settings where they could benefit Veterans. This novel work will address this critical gap and could transform communication with Veterans about prevention in ways that will improve their health outcomes.

The following 5 strategies will be implemented in the weekly messages that study participants will receive: (1) tailoring to aspirations in life; (2) implementation intentions; (3) preference checklists; (4) urgency framing; (5) social norms. The investigators will implement these strategies alone and in combination in a 16-arm factorial design experiment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Prevention
盲法
Single (Investigator)

入排标准

年龄范围
— 至 75 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • HbA1c test within the past 6 months that meets the ADA/CDC requirements for prediabetes.
  • Currently registered in the VA's MyHealtheVet Secure Messaging System
  • Receiving care within the Ann Arbor VA Healthcare System

排除标准

  • Completed more than 4 VA MOVE! classes in the last year (or other evidence of another recent weight loss program)
  • Are trying to lose weight and are very physically active
  • Are >75 years of age
  • Are pregnant or plan to be
  • Are taking Metformin
  • Have participated in the FINDIT study (this study's predecessor under the same grant funding)
  • Have been hospitalized or received rehab for stroke or myocardial infarction within past 6 months
  • Have received chemotherapy for cancer in the past 6 months
  • Self-report or have any International Classification of Diseases (ICD-9/10) codes for:
  • Major functional limitations
  • Cirrhosis
  • Global Initiative for Chronic Obstructive Lung Disease (GOLD) stage 4 chronic obstructive pulmonary disease (COPD)
  • End stage renal disease (ESRD)
  • New York Heart Association (NYHA) class III or IV congestive heart failure (CHF)

结局指标

主要结局

Engagement in Recommended Behaviors to Prevent Type 2 Diabetes

时间窗: 3 months

The investigators will use survey and medical record data to evaluate changes in participants' engagement in recommended behaviors to prevent type 2 diabetes.

次要结局

  • Weight Loss Behaviors(3 months)
  • Perception for Risk for T2DM(3 months)
  • Motivation to Prevent Type 2 Diabetes(3 months)
  • Use of Medication for T2DM Prevention(3 months)
  • Knowledge of Strategies to Prevent T2DM(3 months)
  • Importance of Preventing Type 2 Diabetes(3 months)
  • Participation in Weight-related Wellness Programs(3 months)
  • Physical Activity(3 months)

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (2)

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