General SurgeryNCT02741895
Using Fitbit to Monitor Ambulation in Patients After Surgery.
An observational study of General Surgery, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- General Surgery
- What is being tested?
- Fitbit monitoring
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 135 participants
- Where
- 1 siteUnited States
- Study dates
- May 2016to Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars-Sinai Medical Center
Los Angeles, California, 90048
About this study
Official title: Using Wearable Biosensors to Monitor Ambulation After Major Surgery: Optimizing Efficiency of Postoperative Recovery
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.
Read the 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.
- Conditions
- General Surgery
- Being tested
- Fitbit monitoring
- Keywords
- Biosensing Techniques, Patient Readmission
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fitbit monitoringBehavioural
Patients will be fitted with a Fitbit after surgery, which will monitor steps and active minutes for the duration of hospitalization.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Fitbit monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Location of disposition
Home, Rehab Facility, or Skilled Nursing Facility
Measured: Through study completion, on average 1 week
30-day readmission
Presence or absence of readmission to hospital or ER visit within 30 days of discharge.
Measured: 30 days post discharge
Number of steps
Number of steps per day during hospitalization, per Fitbit data.
Measured: Through study completion, on average 1 week
Active minutes
Active minutes per day during hospitalization, per Fitbit data.
Measured: Through study completion, on average 1 week
Physician daily assessment of ambulatory status
Physician daily assessment of ambulatory status
Measured: Through study completion, on average 1 week
Length of stay
Days from admission (end time of surgery) until discharge from hospital.
Measured: Through study completion, on average 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2016 (estimated)
- Study startMay 2016
- Primary completionNov 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for General SurgeryStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Timothy J. Daskivich, Cedars-Sinai Medical Center
- Investigators
- Timothy J Daskivich, MD, MSHPM, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02741895
- Sponsor's protocol ID
- Pro00044059
- Status last verified
- Jan 2018
- First submitted
- 12 Apr 2016
- Last updated
- 30 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: We have not yet considered a plan to share data.
Publications
Chandrasekaran S, Ariaretnam SK, Tsung J, Dickison D. Early mobilization after total knee replacement reduces the incidence of deep venous thrombosis. ANZ J Surg. 2009 Jul;79(7-8):526-9. doi: 10.1111/j.1445-2197.2009.04982.x.
PubMed 19694660Garcia Guerrero JJ, Fernandez de la Concha Castaneda J, Lopez Quero D, Collado Bueno G, Infante de la Torre JR, Rayo Madrid JI, Redondo Mendez A. Lower incidence of venous thrombosis with temporary active-fixation lead implantation in mobile patients. Europace. 2010 Nov;12(11):1604-7. doi: 10.1093/europace/euq262. Epub 2010 Jul 28.
PubMed 20667893Pearse 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.
PubMed 17356141Kamel HK, Iqbal MA, Mogallapu R, Maas D, Hoffmann RG. Time to ambulation after hip fracture surgery: relation to hospitalization outcomes. J Gerontol A Biol Sci Med Sci. 2003 Nov;58(11):1042-5. doi: 10.1093/gerona/58.11.m1042.
PubMed 14630887Delaney CP, Zutshi M, Senagore AJ, Remzi FH, Hammel J, Fazio VW. Prospective, randomized, controlled trial between a pathway of controlled rehabilitation with early ambulation and diet and traditional postoperative care after laparotomy and intestinal resection. Dis Colon Rectum. 2003 Jul;46(7):851-9. doi: 10.1007/s10350-004-6672-4.
PubMed 12847356Rath S, Schreuders TA, Stam HJ, Hovius SE, Selles RW. Early active motion versus immobilization after tendon transfer for foot drop deformity: a randomized clinical trial. Clin Orthop Relat Res. 2010 Sep;468(9):2477-84. doi: 10.1007/s11999-010-1342-4. Epub 2010 Apr 17.
PubMed 20401554Browning L, Denehy L, Scholes RL. The quantity of early upright mobilisation performed following upper abdominal surgery is low: an observational study. Aust J Physiother. 2007;53(1):47-52. doi: 10.1016/s0004-9514(07)70061-2.
PubMed 17326738Larsen K, Hansen TB, Thomsen PB, Christiansen T, Soballe K. Cost-effectiveness of accelerated perioperative care and rehabilitation after total hip and knee arthroplasty. J Bone Joint Surg Am. 2009 Apr;91(4):761-72. doi: 10.2106/JBJS.G.01472.
PubMed 19339559Kalisch BJ, Landstrom GL, Hinshaw AS. Missed nursing care: a concept analysis. J Adv Nurs. 2009 Jul;65(7):1509-17. doi: 10.1111/j.1365-2648.2009.05027.x. Epub 2009 May 9.
PubMed 19456994Kalisch BJ, Tschannen D, Lee H, Friese CR. Hospital variation in missed nursing care. Am J Med Qual. 2011 Jul-Aug;26(4):291-9. doi: 10.1177/1062860610395929. Epub 2011 Jun 3.
PubMed 21642601Brown CJ, Friedkin RJ, Inouye SK. Prevalence and outcomes of low mobility in hospitalized older patients. J Am Geriatr Soc. 2004 Aug;52(8):1263-70. doi: 10.1111/j.1532-5415.2004.52354.x.
PubMed 15271112Callen BL, Mahoney JE, Grieves CB, Wells TJ, Enloe M. Frequency of hallway ambulation by hospitalized older adults on medical units of an academic hospital. Geriatr Nurs. 2004 Jul-Aug;25(4):212-7. doi: 10.1016/j.gerinurse.2004.06.016.
PubMed 15311196Collins FS, Varmus H. A new initiative on precision medicine. N Engl J Med. 2015 Feb 26;372(9):793-5. doi: 10.1056/NEJMp1500523. Epub 2015 Jan 30.
PubMed 25635347Topol EJ. The creative destruction of medicine : how the digital revolution will create better health care. 1st pbk. ed. New York: Basic Books; 2013.
Augustyniak P. Wearable wireless heart rate monitor for continuous long-term variability studies. J Electrocardiol. 2011 Mar-Apr;44(2):195-200. doi: 10.1016/j.jelectrocard.2010.11.014.
PubMed 21353066
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Wearable Biosensors to Monitor Ambulation After Major Surgery: Optimizing Efficiency of Postoperative Recovery
- ClinicalTrials.gov ID
- NCT02741895
- Acronym / sponsor ID
- Pro00044059
- Conditions
- General Surgery
- Keywords
- Biosensing Techniques, Patient Readmission
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- May 2016 (actual)
- Primary completion
- Nov 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 18 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Postoperative patients | – | Behavioral: Fitbit monitoringThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fitbit monitoringPatients will be fitted with a Fitbit after surgery, which will monitor steps and active minutes for the duration of hospitalization. | Behavioural | Postoperative patients |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2018.
- Background: PubMed 19694660Chandrasekaran S, Ariaretnam SK, Tsung J, Dickison D. Early mobilization after total knee replacement reduces the incidence of deep venous thrombosis. ANZ J Surg. 2009 Jul;79(7-8):526-9. doi: 10.1111/j.1445-2197.2009.04982.x.
- Background: PubMed 20667893Garcia Guerrero JJ, Fernandez de la Concha Castaneda J, Lopez Quero D, Collado Bueno G, Infante de la Torre JR, Rayo Madrid JI, Redondo Mendez A. Lower incidence of venous thrombosis with temporary active-fixation lead implantation in mobile patients. Europace. 2010 Nov;12(11):1604-7. doi: 10.1093/europace/euq262. Epub 2010 Jul 28.
- Background: PubMed 17356141Pearse 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.
- Background: PubMed 14630887Kamel HK, Iqbal MA, Mogallapu R, Maas D, Hoffmann RG. Time to ambulation after hip fracture surgery: relation to hospitalization outcomes. J Gerontol A Biol Sci Med Sci. 2003 Nov;58(11):1042-5. doi: 10.1093/gerona/58.11.m1042.
- Background: PubMed 12847356Delaney CP, Zutshi M, Senagore AJ, Remzi FH, Hammel J, Fazio VW. Prospective, randomized, controlled trial between a pathway of controlled rehabilitation with early ambulation and diet and traditional postoperative care after laparotomy and intestinal resection. Dis Colon Rectum. 2003 Jul;46(7):851-9. doi: 10.1007/s10350-004-6672-4.
- Background: PubMed 20401554Rath S, Schreuders TA, Stam HJ, Hovius SE, Selles RW. Early active motion versus immobilization after tendon transfer for foot drop deformity: a randomized clinical trial. Clin Orthop Relat Res. 2010 Sep;468(9):2477-84. doi: 10.1007/s11999-010-1342-4. Epub 2010 Apr 17.
- Background: PubMed 17326738Browning L, Denehy L, Scholes RL. The quantity of early upright mobilisation performed following upper abdominal surgery is low: an observational study. Aust J Physiother. 2007;53(1):47-52. doi: 10.1016/s0004-9514(07)70061-2.
- Background: PubMed 19339559Larsen K, Hansen TB, Thomsen PB, Christiansen T, Soballe K. Cost-effectiveness of accelerated perioperative care and rehabilitation after total hip and knee arthroplasty. J Bone Joint Surg Am. 2009 Apr;91(4):761-72. doi: 10.2106/JBJS.G.01472.
- Background: PubMed 19456994Kalisch BJ, Landstrom GL, Hinshaw AS. Missed nursing care: a concept analysis. J Adv Nurs. 2009 Jul;65(7):1509-17. doi: 10.1111/j.1365-2648.2009.05027.x. Epub 2009 May 9.
- Background: PubMed 21642601Kalisch BJ, Tschannen D, Lee H, Friese CR. Hospital variation in missed nursing care. Am J Med Qual. 2011 Jul-Aug;26(4):291-9. doi: 10.1177/1062860610395929. Epub 2011 Jun 3.
- Background: PubMed 15271112Brown CJ, Friedkin RJ, Inouye SK. Prevalence and outcomes of low mobility in hospitalized older patients. J Am Geriatr Soc. 2004 Aug;52(8):1263-70. doi: 10.1111/j.1532-5415.2004.52354.x.
- Background: PubMed 15311196Callen BL, Mahoney JE, Grieves CB, Wells TJ, Enloe M. Frequency of hallway ambulation by hospitalized older adults on medical units of an academic hospital. Geriatr Nurs. 2004 Jul-Aug;25(4):212-7. doi: 10.1016/j.gerinurse.2004.06.016.
- Individual participant dataSharing planned: Undecided. We have not yet considered a plan to share data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timothy J Daskivich, MD, MSHPM principal investigator
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of General Surgery, run by Cedars-Sinai Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Location of disposition (time frame: Through study completion, on average 1 week). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02741895, which also lists 22 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2018.