NCT03711149

Brief Summary

This is a randomized controlled trial that compares a system using activity monitors to provide real-time feedback on daily ambulation to patients undergoing major surgeries, paired with step-count-measured art tours of the surgical units, versus standard of care, on step count. The hypothesis is that the feedback system + art tours will encourage patients to ambulate more.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
192

participants targeted

Target at P75+ for not_applicable surgery

Timeline
Completed

Started Dec 2018

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 11, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 18, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

December 5, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 22, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2019

Completed
Last Updated

March 29, 2019

Status Verified

March 1, 2019

Enrollment Period

11 months

First QC Date

October 11, 2018

Last Update Submit

March 27, 2019

Conditions

Surgery

Keywords

AmbulationLength of stayPatient SatisfactionActivity MonitorDigital Health

Outcome Measures

Primary Outcomes (1)

  • Daily Step Count

    Daily step count will be captured with activity monitor

    During hospitalization within approximately 1-2 weeks

Secondary Outcomes (2)

  • Length of stay

    Within approximately 1-2 weeks, Date patient was admitted through hospital discharge

  • Patient Satisfaction

    Within approximately 1-2 weeks, Day patient is discharged from hospital

Study Arms (2)

Intervention Arm

EXPERIMENTAL

Intervention: Activity monitor feedback loop: (1) Subjects will receive activity monitor with feedback on daily step count from the in-room TV screen, and (2) access to the Art Tour application

Other: Activity monitor feedback loop

Standard-of-care Arm

NO INTERVENTION

Subjects in the control arm will receive a "blinded" activity monitor post-op (without feedback on step count) and the usual standard of care. Nurses and doctors will not monitor ambulation with the activity monitor, they will use standard methods of observation.

Interventions

Activity monitor feedback loopOTHER

The intervention arm will test if the feedback system (i.e., activity monitor, real-time feedback, and art tours) increases daily step count, decreases length of stay, and improves patient and provider communication, patient awareness of step count goals, and patient confidence in accomplishment of daily goals.

Intervention Arm

Eligibility Criteria

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

You may qualify if:

  • Undergoing one of the 14 surgeries: Gynecological (Total Abdominal Hysterectomy, Gyn Ex Lap); Orthopedic (Total Hip Replacement, Total Knee Replacement); Minimally Invasive Surgery (Hiatal Hernia Repair/Fundoplication, Gastric Bypass, Gastric Sleeve); Colorectal Surgery (Lap/Robotic Colectomy, Ileocolic Resection, Open Colectomy); Thoracic (Lung Lobectomy); Urologic (Robotic Cystectomy, Radical Prostatectomy, Partial Nephrectomy).
  • Able to provide informed consent
  • Non-English speakers will be included with the use of short forms in the 7 available languages
  • Must have access to an IOS or Android device

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, cane, 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 activity monitor in place
  • Unable to place activity monitor 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

RECRUITING

MeSH Terms

Conditions

Patient Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Timothy Daskivich, MD, MSHPM

    Cedars-Sinai Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Timothy Daskivich, MD, MSHPM

CONTACT

(310) 423-4700timothy.daskivich@csmc.edu

Mayra L Lopez, MPH

CONTACT

mayra.lopez@cshs.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: This randomized controlled trial will involve two arms: (1) and intervention arm consisting of activity monitor feedback loop and art tours and (2) control group consisting of standard of care.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Health Services Research, Department of Surgery

Study Record Dates

First Submitted

October 11, 2018

First Posted

October 18, 2018

Study Start

December 5, 2018

Primary Completion

October 22, 2019

Study Completion

December 30, 2019

Last Updated

March 29, 2019

Record last verified: 2019-03

Locations

US(1)