Recruiting

Observational Study

Sponsor:

Cedars-Sinai Medical Center

Code:

NCT03711149

Conditions

Surgery

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Activity monitor feedback loop

Study Details

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.

Conditions

Surgery

Study ID

NCT03711149

Start date

Dec 5, 2018

Status verified date

Mar, 2019

Completion date

Dec 30, 2019

Anticipated

Primary completion date

Oct 22, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

192 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Intervention Arm

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

no intervention: Standard-of-care Arm

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 loop

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.

Primary outcome measure

  • Daily Step Count [ Time Frame: During hospitalization within approximately 1-2 weeks ]

Central Contacts and Locations

Central contacts

Timothy Daskivich, MD, MSHPM

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

Mayra L Lopez, MPH

mayra.lopez@cshs.org

Locations

Cedars-Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

More Information

Sponsor

Cedars-Sinai Medical Center

Last update posted

Mar 29, 2019

Last verified

Mar, 2019

Keywords

  • Ambulation
  • Length of stay
  • Patient Satisfaction
  • Activity Monitor
  • Digital Health

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Cedars-Sinai Medical Center on 2019-03-29.