Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
48 participants
INTERVENTIONAL
2016-07-31
2016-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
Education regarding ambulation
The participants will be educated on the importance of postoperative ambulation during the recovery period.
Ambulation reminder alarms
Participants in the intervention arm will receive 5 daily alarms to prompt them to ambulate. Alarms will be set to ring at 9am, 11am, 2pm, 5pm and 9pm. The Fitbit will be worn from the day of surgery (postoperative day 0) through postoperative day 9 or hospital discharge, whichever occurs first.
Fitbit
Participants who are postoperative for colorectal surgery, who have been cleared to ambulate during recover, will be equipped with an off-the-shelf Fitbit device (a wireless activity tracking device) which will record steps taken while the participant is hospitalized. The Fitbit will be worn from the day of surgery (postoperative day 0) through postoperative day 9 or hospital discharge, whichever occurs first.
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.
Education regarding ambulation
The participants will be educated on the importance of postoperative ambulation during the recovery period.
Fitbit
Participants who are postoperative for colorectal surgery, who have been cleared to ambulate during recover, will be equipped with an off-the-shelf Fitbit device (a wireless activity tracking device) which will record steps taken while the participant is hospitalized. The Fitbit will be worn from the day of surgery (postoperative day 0) through postoperative day 9 or hospital discharge, whichever occurs first.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Education regarding ambulation
The participants will be educated on the importance of postoperative ambulation during the recovery period.
Ambulation reminder alarms
Participants in the intervention arm will receive 5 daily alarms to prompt them to ambulate. Alarms will be set to ring at 9am, 11am, 2pm, 5pm and 9pm. The Fitbit will be worn from the day of surgery (postoperative day 0) through postoperative day 9 or hospital discharge, whichever occurs first.
Fitbit
Participants who are postoperative for colorectal surgery, who have been cleared to ambulate during recover, will be equipped with an off-the-shelf Fitbit device (a wireless activity tracking device) which will record steps taken while the participant is hospitalized. The Fitbit will be worn from the day of surgery (postoperative day 0) through postoperative day 9 or hospital discharge, whichever occurs first.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* Have an open abdomen due to surgical complications
* Wound Vacuum Assisted Closure (VAC) dependent
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Emory University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Patrick Sean Sullivan MD
MD
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Patrick S Sullivan, MD
Role: PRINCIPAL_INVESTIGATOR
Emory University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Emory University Hospital
Atlanta, Georgia, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IRB00088864
Identifier Type: -
Identifier Source: org_study_id