Using Activity Monitoring and Text Messaging For Behavior Change in a Diabetes Self-Management Program
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 4
- 主要终点
- physical activity
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •Disability, medical or surgical condition preventing or precluding moderate physical activity.
- •Significant cognitive deficits.
结局指标
主要结局
physical activity
时间窗: 6 months
Physical activity will be assessed by step counts measured by an ActiHealth pedometer and compared between the study arms.
次要结局
- Clinical outcome(over 6 months (Day 1 and day 180))
- Engagement to program(6 months)
- Change in physical activity behaviors(6 months)
- Satisfaction with the program(6 months)
研究者
Joseph C. Kvedar
Dermatologist
Massachusetts General Hospital