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Text to Move (TTM)Study (TTM)

2020年8月29日 更新者:Joseph C. Kvedar、Massachusetts General Hospital

Using Activity Monitoring and Text Messaging For Behavior Change in a Diabetes Self-Management Program

This study is a 2-arm randomized controlled trial examining the effect of personalized text messages on physical activity and clinical outcomes in patients with type 2 diabetes mellitus.

The investigators hypothesize that:

i. The use of personalized text messages will promote physical activity in patients with T2DM.

ii. Increased physical activity and behavior change correlate with better clinical outcomes (Change in HbA1c).

iii. The text messaging program will lead to sustained physical activity behavior change in patients with T2DM

研究概览

详细说明

Patients are referred into a Diabetes Self-Management Education (DSME) Support Program at Massachusetts General Hospital by a primary care provider at the time of diagnosis or as needed to gain better knowledge, awareness and understanding of their disease. Majority of the patients in the DSME program experience favorable outcomes; however, in key areas of T2DM management such as physical activity and nutrition, fewer patients experience success with their behavior goals, owing to the higher level of motivation required, and our inability to provide more frequent individually tailored feedback and coaching. In addition, we have observed that patients' behavior change is not sustained over time after finishing the DSME program.

In the proposed study, the investigators intend to augment DSME's evidence-based approach with two key connected health cornerstones - objective data collection and targeted personalized feedback. Using these two tools, we hypothesize that patients will be able to acquire new behaviors much sooner than status quo, and also maintain them for longer. Also, the scalability of the mobile component of the innovation will help us offer this evidence-based program to a much larger pool of patients, contributing greatly to the overall quality of diabetes management at our hospital.

The research team at Center for Connected Health will recruit participants from a pool of patients with T2DM who are participating in or who have gone through the DSME program at MGH Chelsea, MGH Revere or MGH Charlestown. These practices represent the most medically under served areas and serve low-income population. All of these practices have received recognition from the American Diabetes Association as having high-quality diabetes self-management education programs that meet the National Standards for Diabetes Self-Management Education.

120 participants will be enrolled and randomly assigned to one of the two groups.

研究类型

介入性

注册 (实际的)

126

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Massachusetts
      • Boston、Massachusetts、美国、02114
        • Center for Connected Health
      • Boston、Massachusetts、美国、02114
        • Partners Healthcare Center for Connected Health

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Adults over the age of 18 years.
  • HbA1c over 7.0%
  • Patients with a diagnosis of T2DM at MGH Chelsea, MGH Revere MGH Charlestown or MGH Everett will be offered enrollment in the study.
  • Must be willing to attend initial and close-out study visits
  • Willingness to receive a maximum of 60 text messages/month for 6 months on their personal cellular phone.
  • PC computer with internet access
  • Fluency in English or Spanish (spoken and written)

Exclusion Criteria:

  • Disability, medical or surgical condition preventing or precluding moderate physical activity.
  • Significant cognitive deficits.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:支持治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
其他:Usual care group
Subjects in this group will receive the usual standard of care available at MGH.
  • Participants will receive diabetic medical care as usual.
  • In addition, participants in the control group will be given an ActiHealth pedometer to measure daily activity (step counts will be used as a proxy for activity).
其他名称:
  • 控制
实验性的:Text messaging group
Subjects in this group will be enrolled to receive text messages aimed at providing bite-sized coaching based on measured step count to help improve activity levels and providing reminder, educational and motivation messages aimed at helping patients to meet their diabetes self-management goals.
  • Participants will receive diabetic medical care as usual.
  • Participants will be given an ActiHealth pedometer to measure daily activity.
  • In addition, they will be enrolled to receive the study text messages.
其他名称:
  • 短信

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
physical activity
大体时间:6 months
Physical activity will be assessed by step counts measured by an ActiHealth pedometer and compared between the study arms.
6 months

次要结果测量

结果测量
措施说明
大体时间
Clinical outcome
大体时间:over 6 months (Day 1 and day 180)
Will be assessed by pre and post HbA1c measurements
over 6 months (Day 1 and day 180)
Change in physical activity behaviors
大体时间:6 months
This will be assessed by Pre and post stage of behavior change based on the Stages of Motivational Readiness for Change model of the TTM.
6 months
Satisfaction with the program
大体时间:6 months
This will be assessed using standardized Questionnaires at closeouts
6 months
Engagement to program
大体时间:6 months

This will be measure quantitatively by:

  • number of days participant wore their pedometers in the study;
  • number of logins to the ActiHealth step count web portal;
  • percentage of messages a user responds to, in 2-way text messages
6 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Kamal Jethwani, MD, MPH、Center for Connected Health

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2012年6月1日

初级完成 (实际的)

2013年10月1日

研究完成 (实际的)

2013年10月1日

研究注册日期

首次提交

2012年3月28日

首先提交符合 QC 标准的

2012年3月30日

首次发布 (估计)

2012年4月3日

研究记录更新

最后更新发布 (实际的)

2020年9月1日

上次提交的符合 QC 标准的更新

2020年8月29日

最后验证

2020年8月1日

更多信息

与本研究相关的术语

其他研究编号

  • 2011-P-002708/1; MGH

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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