Using Fitbit to Monitor Ambulation in Patients After Surgery.
NCT ID: NCT02741895
Last Updated: 2018-01-30
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
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COMPLETED
135 participants
OBSERVATIONAL
2016-05-31
2017-12-31
Brief Summary
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Detailed Description
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To supplement Fitbit data, a research coordinator will collect clinical data from chart review of the electronic health record (age, gender, race/ethnicity, body mass index, comorbid health conditions), and enter the data into a secure spreadsheet.
Physicians will also be participating in the study by providing data on estimated daily ambulation, using a standard formatted scale. Surgeons currently assess daily ambulation in the medical record, but assessments are not uniform, which precludes meaningful comparisons between providers. Investigators will therefore ask physicians to record daily estimates of ambulatory status according to standardized terms that are commonly used in the medical record (nonambulatory; out of bed to chair; out of bed to ambulate (QD, BID, TID); and ambulating ad lib). Investigators will also collect information on daily ambulation orders as entered by the provider team as part of routine practice. This information will be ascertained by chart review and entered into the secure spreadsheet along with the additional patient data.
The Fitbit device has a battery life of approximately 7 days, so investigators will plan to recharge and download information every 5 days.
At the time of discharge, a study team member will remove the device and download the information from the device to a secure spreadsheet. The wearable biosensor will be reset at that time and the information will be erased from its memory. Investigators will also clean the wearable biosensors with disinfectant used for durable medical equipment.
Investigators will also query the medical record for information regarding disposition outcomes, including length of stay (from end of surgery to discharge from the hospital) and location of disposition (to home, rehab facility, or skilled nursing facility). Investigators will then contact the patients by phone after 30 days have elapsed since discharge to inquire whether they have been readmitted to the hospital or ER within the 30 days of their discharge date.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Postoperative patients
The target populations for the study are patients undergoing robotic cystectomy, open colectomy, abdominal hysterectomy, esophagectomy, lung lobectomy, gastric bypass, and hip replacement at Cedars-Sinai Medical Center.
Fitbit monitoring
Patients will be fitted with a Fitbit after surgery, which will monitor steps and active minutes for the duration of hospitalization.
Interventions
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Fitbit monitoring
Patients will be fitted with a Fitbit after surgery, which will monitor steps and active minutes for the duration of hospitalization.
Eligibility Criteria
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Inclusion Criteria
* Undergoing robotic cystectomy, open colectomy, abdominal hysterectomy, esophagectomy, lung lobectomy, gastric bypass, or hip replacement
* Able to provide informed consent
Exclusion Criteria
2. Not undergoing procedure of interest
3. Admitted to ICU directly after operation (except esophagectomy, where all patients are admitted to ICU directly after the operation)
4. Use of walker, cancer, or wheelchair at baseline
5. Presence of physical limitations on walking (i.e. amputation)
6. Usual place of residence is skilled nursing facility
7. Cognitive inability to follow directions to maintain biosensor in place
8. Unable to place biosensor on patient's wrist
18 Years
ALL
No
Sponsors
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Cedars-Sinai Medical Center
OTHER
Responsible Party
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Timothy J. Daskivich
Assistant Professor, Urology Academic Practice
Principal Investigators
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Timothy J Daskivich, MD, MSHPM
Role: PRINCIPAL_INVESTIGATOR
Cedars-Sinai Medical Center
Locations
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Cedars-Sinai Medical Center
Los Angeles, California, United States
Countries
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References
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Pearse EO, Caldwell BF, Lockwood RJ, Hollard J. Early mobilisation after conventional knee replacement may reduce the risk of postoperative venous thromboembolism. J Bone Joint Surg Br. 2007 Mar;89(3):316-22. doi: 10.1302/0301-620X.89B3.18196.
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ATKINSON GS. Early post-operative ambulation. Clin Med (Northfield). 1948 Dec;55(12):245. No abstract available.
Other Identifiers
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Pro00044059
Identifier Type: -
Identifier Source: org_study_id
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