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Activity Monitor Feedback and Interactive Tours to Improve Postoperative Ambulation

NCT ID: NCT03711149

Last Updated: 2019-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

192 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-05

Study Completion Date

2019-12-30

Brief Summary

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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.

Detailed Description

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After major surgery, patients are encouraged to walk early and often, since early ambulation is linked with improved clinical and efficiency outcomes. This research study tests whether providing goal-directed feedback on daily ambulation to patients using activity monitors in combination with an app that provides step count-rated "art tours" of the surgical floors will increase the amount of steps taken after surgery. Upon enrollment, all patients will be assigned to either the control (no intervention) or experimental (activity monitor feedback + art tours) group, stratified by surgery type. This randomized controlled trial aims to determine if this feedback system/art tours approach improves: (1) daily step count, (2) length of stay, and (3) patient satisfaction compared with standard of care.

Conditions

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Surgery

Keywords

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Ambulation Length of stay Patient Satisfaction Activity Monitor Digital Health

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Activity monitor feedback loop

Intervention Type OTHER

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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cedars-Sinai Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Timothy J. Daskivich

Director of Health Services Research, Department of Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Timothy Daskivich, MD, MSHPM

Role: PRINCIPAL_INVESTIGATOR

Cedars-Sinai Medical Center

Locations

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Cedars-Sinai Medical Center

Los Angeles, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Timothy Daskivich, MD, MSHPM

Role: CONTACT

Phone: (310) 423-4700

Email: [email protected]

Mayra L Lopez, MPH

Role: CONTACT

Email: [email protected]

Facility Contacts

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Mayra L Lopez, MPH

Role: primary

Other Identifiers

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Pro00051802

Identifier Type: -

Identifier Source: org_study_id