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Trial record 1 of 1 for:    NCT02741895
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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
Sponsor:
Information provided by (Responsible Party):
Timothy J. Daskivich, Cedars-Sinai Medical Center

Study Description
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Brief Summary:
This study will evaluate whether information on postoperative ambulation from Fitbits can improve surgeons' ability to monitor ambulation and identify patients at risk for prolonged length of stay, 30-day readmissions, and discharge to transitional care after major surgery.

Condition or disease Intervention/treatment
General Surgery Behavioral: Fitbit monitoring

Detailed Description:

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 Design
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Study Type : Observational
Actual Enrollment : 135 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Groups and Cohorts
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Group/Cohort Intervention/treatment
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.
 Behavioral: Fitbit monitoring
Patients will be fitted with a Fitbit after surgery, which will monitor steps and active minutes for the duration of hospitalization.


Outcome Measures
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Primary Outcome Measures :
  1. Location of disposition [ Time Frame: Through study completion, on average 1 week ]
    Home, Rehab Facility, or Skilled Nursing Facility

  2. 30-day readmission [ Time Frame: 30 days post discharge ]
    Presence or absence of readmission to hospital or ER visit within 30 days of discharge.

  3. Number of steps [ Time Frame: Through study completion, on average 1 week ]
    Number of steps per day during hospitalization, per Fitbit data.

  4. Active minutes [ Time Frame: Through study completion, on average 1 week ]
    Active minutes per day during hospitalization, per Fitbit data.

  5. Physician daily assessment of ambulatory status [ Time Frame: Through study completion, on average 1 week ]
    Physician daily assessment of ambulatory status

  6. Length of stay [ Time Frame: Through study completion, on average 1 week ]
    Days from admission (end time of surgery) until discharge from hospital.


Eligibility Criteria
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Information from the National Library of Medicine

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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
Study Population
Surgical inpatients who have undergone one of the following: robotic cystectomy, open colectomy, abdominal hysterectomy, esophagectomy, lung lobectomy, gastric bypass, or hip replacement.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  1. Unable to provide consent
  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
Contacts and Locations
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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): NCT02741895


Locations
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United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Sponsors and Collaborators
Cedars-Sinai Medical Center
Investigators
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Principal Investigator: Timothy J Daskivich, MD, MSHPM Cedars-Sinai Medical Center
More Information
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Publications:
Topol EJ. The creative destruction of medicine : how the digital revolution will create better health care. 1st pbk. ed. New York: Basic Books; 2013.

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Responsible Party: Timothy J. Daskivich, Assistant Professor, Urology Academic Practice, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT02741895    
Other Study ID Numbers: Pro00044059
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.
Keywords provided by Timothy J. Daskivich, Cedars-Sinai Medical Center:
Biosensing Techniques
Patient Readmission