Randomized Clinical Trial of FitBit and Mobile Apps Versus Usual Care to Improve Post-Operative Outcomes After GI Cancer Surgery
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 107
- 试验地点
- 1
- 主要终点
- Readmission rate
研究概览
简要总结
This is a randomized clinical trial to evaluate the use of mobile devices in preventing readmission in patients undergoing major GI cancer operations.
详细描述
Patients will be randomized to 1) standard of care or 2) to use our mobile app with standard care. The mobile app will collect information on patients' daily physical activity patterns and health status data for clinicians using smartphone mobile technology applications. The investigators believe that by tracking information on patients, the investigators may be able to intervene sooner and prevent a delay in care.
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
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
- •Subject is 18 years or older
- •Subject speaks English
- •Subject owns a smart phone
- •Subject is scheduled to undergo surgery for a GI cancer (pancreatic, hepatic, gastric, small bowel, colon, or rectal cancers)
排除标准
- •Physician deems the subject is unable to complete the study due to documented dementia
- •Subject is undergoing emergent surgery
- •Subject has sepsis from another source
- •Physician deems the subject is unable to complete the study due to documented alcohol and/or drug abuse
研究组 & 干预措施
Mobile app and Fitbit + Standard of care
Mobile health application and Fitbit + standard of care: Participants will utilize mobile app and Fitbit and standard of care. Mobility data will be generated using a mobile health tracker designed for smartphone devices.
干预措施: Mobile health application and Fitbit + standard of care (Other)
Standard of care
Participants will receive standard of care
干预措施: Standard of care (Other)
结局指标
主要结局
Readmission rate
时间窗: 30 days
Investigators will track readmission rates after surgery for those on the trial
次要结局
- Quality of life: Return to Baseline Function-Activities of Daily Living (ADLs)(30 days)
- Healthcare utilization rates(30 days)
- Patient Satisfaction with Device(30 days)
- Quality of life: Return to Baseline Function-Walking(30 days)