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Fitbit for Postoperative Ambulation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02833324
First Posted: July 14, 2016
Last Update Posted: October 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Patrick Sean Sullivan MD, Emory University
  Purpose
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.

Condition Intervention
Postoperative Care Behavioral: Education regarding ambulation Behavioral: Ambulation reminder alarms Other: Fitbit

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Can a Fitbit (a Mobile Tracking Device) Increase Ambulation of Colorectal Surgical Patients in the Postoperative Period?

Further study details as provided by Patrick Sean Sullivan MD, Emory University:

Primary Outcome Measures:
  • Comparison of number of steps taken between study arms [ Time Frame: 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.


Secondary Outcome Measures:
  • Comparison of time to first ambulation between study arms [ Time Frame: Up to 10 days (postoperative day 0 through postoperative day 9) ]
    The duration of time from administration of the Fitbit device until first postoperative ambulation will be compared between the study arm receiving the ambulation reminder alarms and the study arm without reminder alarms. Participants cleared to ambulate will be given a package containing the Fitbit device, paired study phone, and chargers while in the Post Anesthesia Care Unit (PACU). Participants will be instructed to equip the device prior to discharge from the PACU.

  • Comparison of incidence of prolonged postoperative ileus between study arms [ Time Frame: Up to 10 days (postoperative day 0 through postoperative day 9) ]

    The incidence of prolonged postoperative ileus during hospitalization will be compared between the study arm receiving the ambulation reminder alarms and the study arm without reminder alarms.

    For this study, postoperative ileus is defined as the interval from surgery until there is passage of flatus or stool and an oral diet is tolerated. Prolonged postoperative ileus is determined to be present if two or more of the following criteria are met on or after postoperative day 4, without prior resolution of postoperative ileus:

    • Nausea or vomiting
    • The inability to tolerate an oral diet over 24 hours
    • Absence of flatus over 24 hours
    • Abdominal distension
    • Radiologic confirmation

  • Comparison of incidence of pulmonary complications between study arms [ Time Frame: Up to 10 days (postoperative day 0 through postoperative day 9) ]
    The incidence of pulmonary complications during hospitalization will be compared between the study arm receiving the ambulation reminder alarms and the study arm without reminder alarms. For this study, pulmonary complications are defined as respiratory failure requiring mechanical ventilation, pneumonia, atelectasis requiring bronchoscopic intervention, or pneumothorax or pleural effusion requiring percutaneous intervention.

  • Comparison of incidence of venous thromboembolism between study arms [ Time Frame: Up to 10 days (postoperative day 0 through postoperative day 9) ]
    The incidence of venous thromboembolism occurring during hospitalization will be compared between the study arm receiving the ambulation reminder alarms and the study arm without reminder alarms. Venous thromboembolism is when a blood clot (thrombus) forms within a vein and includes deep vein thrombosis (DVT) and pulmonary embolism (PE).

  • Comparison of length of postoperative hospital stay between study arms [ Time Frame: Up to 10 days (postoperative day 0 through postoperative day 9) ]
    The length of hospitalization following surgery will be compared between the study arm receiving the ambulation reminder alarms and the study arm without reminder alarms.


Enrollment: 48
Study Start Date: July 2016
Study Completion Date: December 2016
Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Behavioral: Education regarding ambulation
The participants will be educated on the importance of postoperative ambulation during the recovery period.
Behavioral: 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.
Other: 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.
Active Comparator: 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.
Behavioral: Education regarding ambulation
The participants will be educated on the importance of postoperative ambulation during the recovery period.
Other: 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.

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02833324


Locations
United States, Georgia
Emory University Hospital
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Patrick S Sullivan, MD Emory University
  More Information

Responsible Party: Patrick Sean Sullivan MD, MD, Emory University
ClinicalTrials.gov Identifier: NCT02833324     History of Changes
Other Study ID Numbers: IRB00088864
First Submitted: July 12, 2016
First Posted: July 14, 2016
Last Update Posted: October 17, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Patrick Sean Sullivan MD, Emory University:
Postoperative Period
Colorectal Surgery
Surgery