Using Fitbit to Monitor Ambulation in Patients After Surgery.
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|ClinicalTrials.gov Identifier: NCT02741895|
Recruitment Status : Completed
First Posted : April 18, 2016
Last Update Posted : January 30, 2018
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|Condition or disease||Intervention/treatment|
|General Surgery||Behavioral: Fitbit monitoring|
After the patient is awake and alert after surgery, a study team member will place the Fitbit device on participants' wrists. Investigators will then monitor daily steps taken and active minutes for the duration of hospitalization, with the option to discontinue if clinically required or requested by the patient or provider. Investigators will record the wearable biosensor number and subject study number on a secure spreadsheet.
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.
|Study Type :||Observational|
|Actual Enrollment :||135 participants|
|Official Title:||Using Wearable Biosensors to Monitor Ambulation After Major Surgery: Optimizing Efficiency of Postoperative Recovery|
|Actual Study Start Date :||May 2016|
|Actual Primary Completion Date :||November 2017|
|Actual Study Completion Date :||December 2017|
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.
Behavioral: Fitbit monitoring
Patients will be fitted with a Fitbit after surgery, which will monitor steps and active minutes for the duration of hospitalization.
- Location of disposition [ Time Frame: Through study completion, on average 1 week ]Home, Rehab Facility, or Skilled Nursing Facility
- 30-day readmission [ Time Frame: 30 days post discharge ]Presence or absence of readmission to hospital or ER visit within 30 days of discharge.
- Number of steps [ Time Frame: Through study completion, on average 1 week ]Number of steps per day during hospitalization, per Fitbit data.
- Active minutes [ Time Frame: Through study completion, on average 1 week ]Active minutes per day during hospitalization, per Fitbit data.
- Physician daily assessment of ambulatory status [ Time Frame: Through study completion, on average 1 week ]Physician daily assessment of ambulatory status
- Length of stay [ Time Frame: Through study completion, on average 1 week ]Days from admission (end time of surgery) until discharge from hospital.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
- 18 years of age or older
- Undergoing robotic cystectomy, open colectomy, abdominal hysterectomy, esophagectomy, lung lobectomy, gastric bypass, or hip replacement
- Able to provide informed consent
- Unable to provide consent
- Not undergoing procedure of interest
- Admitted to ICU directly after operation (except esophagectomy, where all patients are admitted to ICU directly after the operation)
- Use of walker, cancer, or wheelchair at baseline
- Presence of physical limitations on walking (i.e. amputation)
- Usual place of residence is skilled nursing facility
- Cognitive inability to follow directions to maintain biosensor in place
- Unable to place biosensor on patient's wrist
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): NCT02741895
|United States, California|
|Cedars-Sinai Medical Center|
|Los Angeles, California, United States, 90048|
|Principal Investigator:||Timothy J Daskivich, MD, MSHPM||Cedars-Sinai Medical Center|
|Responsible Party:||Timothy J. Daskivich, Assistant Professor, Urology Academic Practice, Cedars-Sinai Medical Center|
|Other Study ID Numbers:||
|First Posted:||April 18, 2016 Key Record Dates|
|Last Update Posted:||January 30, 2018|
|Last Verified:||January 2018|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Undecided|
|Plan Description:||We have not yet considered a plan to share data.|