Clinical trial NCT02833324: Fitbit for Postoperative Ambulation
Official title: Can a Fitbit (a Mobile Tracking Device) Increase Ambulation of Colorectal Surgical Patients in the Postoperative Period?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Care
Keywords: Postoperative Period
Colorectal Surgery
Surgery
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2016-07-14
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Undergoing an elective surgical procedure in colorectal services at Emory University Hospital

Exclusion Criteria:

* Post-surgical admission into the intensive care unit (ICU)
* Have an open abdomen due to surgical complications
* Wound Vacuum Assisted Closure (VAC) dependent

Primary outcomes:
measure: Comparison of number of steps taken between study arms
timeFrame: Up to 10 days (postoperative day 0 through postoperative day 9)
Secondary outcomes:
measure: Comparison of time to first ambulation between study arms
timeFrame: Up to 10 days (postoperative day 0 through postoperative day 9)
measure: Comparison of incidence of prolonged postoperative ileus between study arms
timeFrame: Up to 10 days (postoperative day 0 through postoperative day 9)
measure: Comparison of incidence of pulmonary complications between study arms
timeFrame: Up to 10 days (postoperative day 0 through postoperative day 9)
measure: Comparison of incidence of venous thromboembolism between study arms
timeFrame: Up to 10 days (postoperative day 0 through postoperative day 9)
measure: Comparison of length of postoperative hospital stay between study arms
timeFrame: Up to 10 days (postoperative day 0 through postoperative day 9)
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
Study officials:
affiliation: Emory University
name: Patrick S Sullivan, MD
role: PRINCIPAL_INVESTIGATOR
References: