跳至主要内容
临床试验/NCT04226027
NCT04226027已完成不适用

Dynamically Tailoring Interventions for Problem-Solving in Diabetes Self-Management Using Self-Monitoring Data - a Randomized Controlled Trial (RCT)

Columbia University2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2020年1月17日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
300
试验地点
2
主要终点
Mean HbA1c Value

研究概览

简要总结

In this project, the investigators will evaluate the efficacy of a novel approach to personalizing behavioral interventions for self-management of type 2 diabetes (T2DM) to individuals' behavioral and glycemic profiles discovered using computational learning and self-monitoring data. This study is a two-arm randomized controlled trial with n=280 participants recruited from the participating Federally Qualified Health Centers (FQHCs). The participants will be randomly assigned to the intervention group and the usual care (control) group with 1-1 allocation ratio. Half of the participants (n=140) will be randomly assigned to a usual care (control) group. Both groups will receive standard diabetes education at their respective FQHC site. In addition, the experimental group will receive instructions to use T2.coach for a minimum of 6 months.

详细描述

One of the main difficulties in managing diabetes is that each affected individual requires personally tailored combination of diet, exercise, and medication to effectively control their blood sugar. Rather than strictly following a doctor's prescription, individuals need to carefully examine their lifestyle choices and their impact on their health. Independent learning, experimentation and problem solving become of great importance. However, they can be challenging for individuals with diabetes. In this project, the investigators will refine and evaluate a novel intervention for diabetes self-management that uses computational analysis of self-monitoring data to help individuals with type 2 diabetes identify what daily activities, including consumption of meals, physical activity, and sleep, have impact on blood glucose levels, and suggest modifications to these daily activities to improve blood glucose levels.

Growing evidence highlights significant differences in glycemic function and cultural, social, and economical circumstances of individuals with type 2 diabetes (T2DM) that impact their self-management. Precision medicine strives to personalize medical treatment to an individual's genetic makeup, computationally discovered clinical phenotypes and lifestyle. Studies showed the benefits of tailoring not only medical treatment, but also behavioral interventions. Yet, currently, personalization of self-management in T2DM requires each individual to engage in discovery, reflection, and problem-solving-critical but cognitively demanding activities-or to rely on their healthcare providers. Both of these may present considerable barriers to individuals from medically under-served low income communities. Mobile health (mHealth) solutions in T2DM bring promise of reaching wider populations in need of self-management; however, few such solutions provide assistance with personalizing self-management behaviors. Ongoing efforts on personalizing behavioral interventions outside of T2DM focus on tailoring behavior modification techniques to individuals' psycho-social characteristics, such as self-efficacy ), and tailoring delivery of intervention to individuals' context rather than on personalizing self-management strategies.

The ongoing focus of this research is on developing informatics interventions for diabetes self-management, with a specific focus on discovery with self-monitoring data and on problem-solving for improving glycemic control. In the proposed research the investigators introduce T2.coach, an mHealth intervention that uses computational analysis of self-monitoring data to identify behavioral patterns associated with poor glycemic control and formulate personalized behavioral goals for changing problematic behaviors. This study will evaluate T2.coach's efficacy in a two-arm RCT with stratified randomization conducted with Clinical Directors Network (CDN), a well-recognized primary care practice-based research network (PBRN) of Federally Qualified Health Centers (FQHCs), and Agency for Healthcare Research and Quality (AHRQ)-designated Center of Excellence (P30) for Practice-based Research and Learning.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

盲法说明

Because of the nature of the intervention (smartphone app), masking is not possible.

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient of the health center for ≥ 6 months and a diagnosis of T2DM
  • HbA1c ≥ 8.0,
  • Aged 18 to 65 years
  • Attends diabetes education program at the health center
  • Owns a basic mobile phone
  • Proficient in either English or Spanish

排除标准

  • Presence of severe cognitive impairment (recorded in patient chart),
  • Existence of other serious illnesses (e.g. cancer diagnosis with active treatment, advanced stage heart failure, dialysis, multiple sclerosis, advanced retinopathy, recorded in patient chart),
  • Plans for leaving the FQHC in the next 12 months,
  • Participation in the previous trial of diabetes self-management technologies

研究组 & 干预措施

T2.coach

Experimental

Participants receive standard care (diabetes self-management education provided by their Federally Qualified Community Health Center) and are asked to use T2.coach for 6 months.

干预措施: T2.coach (Behavioral)

Control

No Intervention

Participants receive standard care (diabetes self-management education provided by their Federally Qualified Community Health Center).

结局指标

主要结局

Mean HbA1c Value

时间窗: Baseline, 6 months, 12 months

The main outcome is the mean Hemoglobin A1c at 12 months. In the statistical analysis, we examine difference in mean HbA1c between the study arms at baseline, 6 months, and 12 months.

次要结局

  • SCA-I Score(Baseline, 6 months, 12 months)
  • DSES Score(Baseline, 6 months, 12 months)
  • PAID Score(Baseline, 6 months, 12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Olena Mamykina, PhD

Associate Professor of Biomedical Informatics

Columbia University

研究点 (2)

Loading locations...

相似试验