Can a Fitbit (a Mobile Tracking Device) Increase Ambulation of Colorectal Surgical Patients in the Postoperative Period?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Comparison of number of steps taken between study arms
研究概览
简要总结
This trial will investigate whether using reminder alarms with a wireless activity tracking device (Fitbit) will increase daily ambulation in individuals who have just had colorectal surgery.
详细描述
Early mobilization after surgery has been shown to reduce recovery time, incidence of venous thromboembolism, length of hospital stay and both pulmonary and general post-operative complications. Ambulation is also a main tenant of a fast-track recovery protocol known as Enhanced Recovery After Surgery (ERAS), which is commonly used among colorectal surgical practices and being implanted across other surgical practices. Despite evidence supporting its benefit, early ambulation has been identified as the one of the most difficult clinical interventions to enforce and to measure.
The primary objective of this trial is to investigate whether the use of wireless activity tracking device (Fitbit) with 5 daily reminder alarms will increase daily ambulation on postoperative day 0 until post operative day 9 or hospital discharge (whichever occurs first). Secondary objectives include evaluating the effect of Fitbit as a motivating factor on the frequency of postoperative ileus, time to return of bowel function, number of venous thromboembolism (VTE), pneumonia (PNA) and other pulmonary complications, number of code Medical Emergency Team (MET) alerts, and overall cost saving.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Undergoing an elective surgical procedure in colorectal services at Emory University Hospital
排除标准
- •Post-surgical admission into the intensive care unit (ICU)
- •Have an open abdomen due to surgical complications
- •Wound Vacuum Assisted Closure (VAC) dependent
研究组 & 干预措施
Fitbit with ambulation reminder alarms
Study participants who are postoperative for colorectal surgery will wear a Fitbit (a wireless activity tracking device) to count steps taken during their postoperative hospitalization. In addition to being educated on the importance of postoperative ambulation, this arm will have 5 alarms every day reminding them to ambulate.
干预措施: Education regarding ambulation (Behavioral)
Fitbit with ambulation reminder alarms
Study participants who are postoperative for colorectal surgery will wear a Fitbit (a wireless activity tracking device) to count steps taken during their postoperative hospitalization. In addition to being educated on the importance of postoperative ambulation, this arm will have 5 alarms every day reminding them to ambulate.
干预措施: Ambulation reminder alarms (Behavioral)
Fitbit with ambulation reminder alarms
Study participants who are postoperative for colorectal surgery will wear a Fitbit (a wireless activity tracking device) to count steps taken during their postoperative hospitalization. In addition to being educated on the importance of postoperative ambulation, this arm will have 5 alarms every day reminding them to ambulate.
干预措施: Fitbit (Other)
Fitbit without ambulation reminder alarms
Study participants who are postoperative for colorectal surgery will wear a Fitbit (a wireless activity tracking device) to count steps taken during their postoperative hospitalization. Participants will be educated on the importance of postoperative ambulation but will not have ambulation reminder alarms.
干预措施: Education regarding ambulation (Behavioral)
Fitbit without ambulation reminder alarms
Study participants who are postoperative for colorectal surgery will wear a Fitbit (a wireless activity tracking device) to count steps taken during their postoperative hospitalization. Participants will be educated on the importance of postoperative ambulation but will not have ambulation reminder alarms.
干预措施: Fitbit (Other)
结局指标
主要结局
Comparison of number of steps taken between study arms
时间窗: Up to 10 days (postoperative day 0 through postoperative day 9)
The number of steps taken by each participant will be measured by a Fitbit, which is a wireless activity tracking device. The number of steps taken will be compared between the study arm receiving the ambulation reminder alarms and the study arm without reminder alarms. The Fitbit is commercially available and is worn on the wrist. Data will be collected from the Fitbit wirelessly using a dedicated study data collection phone and linked with an anonymized patient identifier. Data collection phones attached to chargers will be placed in patient rooms within range of the hospital bed to enable automatic wireless data collection.
次要结局
- Comparison of time to first ambulation between study arms(Up to 10 days (postoperative day 0 through postoperative day 9))
- Comparison of incidence of prolonged postoperative ileus between study arms(Up to 10 days (postoperative day 0 through postoperative day 9))
- Comparison of incidence of pulmonary complications between study arms(Up to 10 days (postoperative day 0 through postoperative day 9))
- Comparison of incidence of venous thromboembolism between study arms(Up to 10 days (postoperative day 0 through postoperative day 9))
- Comparison of length of postoperative hospital stay between study arms(Up to 10 days (postoperative day 0 through postoperative day 9))
研究者
Patrick Sean Sullivan MD
MD
Emory University