Fitbit for Postoperative Ambulation

NCT02833324 | Completed

• 1 other identifier: IRB00088864
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Care

Keywords

Postoperative Period; Colorectal Surgery; Surgery

Outcome Measures

Primary Outcomes (1)

• Comparison of number of steps taken between study arms

  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.

  Up to 10 days (postoperative day 0 through postoperative day 9)

Secondary Outcomes (5)

• 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)

Study Arms (2)

Fitbit with ambulation reminder alarms

EXPERIMENTAL

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; Behavioral: Ambulation reminder alarms; Other: Fitbit

Fitbit without ambulation reminder alarms

ACTIVE COMPARATOR

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; Other: Fitbit

Interventions

Education regarding ambulation BEHAVIORAL

The participants will be educated on the importance of postoperative ambulation during the recovery period.

Fitbit with ambulation reminder alarms; Fitbit without ambulation reminder alarms

Ambulation reminder alarms BEHAVIORAL

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 with ambulation reminder alarms

Fitbit OTHER

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 with ambulation reminder alarms; Fitbit without ambulation reminder alarms

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Study Officials

• Patrick S Sullivan, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 12, 2016
• First Posted: July 14, 2016
• Study Start: July 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: October 17, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)