NCT02741895

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
135

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 12, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 18, 2016

Completed
13 days until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

January 30, 2018

Status Verified

January 1, 2018

Enrollment Period

1.5 years

First QC Date

April 12, 2016

Last Update Submit

January 26, 2018

Conditions

General Surgery

Keywords

Biosensing TechniquesPatient Readmission

Outcome Measures

Primary Outcomes (6)

  • Location of disposition

    Home, Rehab Facility, or Skilled Nursing Facility

    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.

    30 days post discharge

  • Number of steps

    Number of steps per day during hospitalization, per Fitbit data.

    Through study completion, on average 1 week

  • Active minutes

    Active minutes per day during hospitalization, per Fitbit data.

    Through study completion, on average 1 week

  • Physician daily assessment of ambulatory status

    Physician daily assessment of ambulatory status

    Through study completion, on average 1 week

  • Length of stay

    Days from admission (end time of surgery) until discharge from hospital.

    Through study completion, on average 1 week

Study Arms (1)

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

Interventions

Fitbit monitoringBEHAVIORAL

Patients will be fitted with a Fitbit after surgery, which will monitor steps and active minutes for the duration of hospitalization.

Postoperative patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Related Publications (22)

  • 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.

    PMID: 19694660BACKGROUND

  • Garcia 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.

    PMID: 20667893BACKGROUND

  • 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.

    PMID: 17356141BACKGROUND

  • Kamel 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.

    PMID: 14630887BACKGROUND

  • Delaney 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.

    PMID: 12847356BACKGROUND

  • Rath 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.

    PMID: 20401554BACKGROUND

  • Browning 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.

    PMID: 17326738BACKGROUND

  • Larsen 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.

    PMID: 19339559BACKGROUND

  • Kalisch 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.

    PMID: 19456994BACKGROUND

  • Kalisch 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.

    PMID: 21642601BACKGROUND

  • Brown 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.

    PMID: 15271112BACKGROUND

  • Callen 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.

    PMID: 15311196BACKGROUND

  • Collins 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.

    PMID: 25635347BACKGROUND

  • Topol EJ. The creative destruction of medicine : how the digital revolution will create better health care. 1st pbk. ed. New York: Basic Books; 2013.

    BACKGROUND

  • 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.

    PMID: 21353066BACKGROUND

  • Shambroom JR, Fabregas SE, Johnstone J. Validation of an automated wireless system to monitor sleep in healthy adults. J Sleep Res. 2012 Apr;21(2):221-30. doi: 10.1111/j.1365-2869.2011.00944.x. Epub 2011 Aug 22.

    PMID: 21859438BACKGROUND

  • Spiegel BM, Kaneshiro M, Russell MM, Lin A, Patel A, Tashjian VC, Zegarski V, Singh D, Cohen SE, Reid MW, Whitman CB, Talley J, Martinez BM, Kaiser W. Validation of an acoustic gastrointestinal surveillance biosensor for postoperative ileus. J Gastrointest Surg. 2014 Oct;18(10):1795-803. doi: 10.1007/s11605-014-2597-y. Epub 2014 Aug 5.

    PMID: 25091837BACKGROUND

  • Appelboom G, Yang AH, Christophe BR, Bruce EM, Slomian J, Bruyere O, Bruce SS, Zacharia BE, Reginster JY, Connolly ES Jr. The promise of wearable activity sensors to define patient recovery. J Clin Neurosci. 2014 Jul;21(7):1089-93. doi: 10.1016/j.jocn.2013.12.003. Epub 2013 Dec 9.

    PMID: 24534628BACKGROUND

  • Dobkin BH. Wearable motion sensors to continuously measure real-world physical activities. Curr Opin Neurol. 2013 Dec;26(6):602-8. doi: 10.1097/WCO.0000000000000026.

    PMID: 24136126BACKGROUND

  • Dobkin BH, Dorsch A. The promise of mHealth: daily activity monitoring and outcome assessments by wearable sensors. Neurorehabil Neural Repair. 2011 Nov-Dec;25(9):788-98. doi: 10.1177/1545968311425908.

    PMID: 21989632BACKGROUND

  • Kalisch BJ, Lee S, Dabney BW. Outcomes of inpatient mobilization: a literature review. J Clin Nurs. 2014 Jun;23(11-12):1486-501. doi: 10.1111/jocn.12315. Epub 2013 Sep 13.

    PMID: 24028657BACKGROUND

  • ATKINSON GS. Early post-operative ambulation. Clin Med (Northfield). 1948 Dec;55(12):245. No abstract available.

    PMID: 18107881BACKGROUND

Study Officials

  • Timothy J Daskivich, MD, MSHPM

    Cedars-Sinai Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Urology Academic Practice

Study Record Dates

First Submitted

April 12, 2016

First Posted

April 18, 2016

Study Start

May 1, 2016

Primary Completion

November 1, 2017

Study Completion

December 1, 2017

Last Updated

January 30, 2018

Record last verified: 2018-01

Locations

US(1)