Patient Ambulation in Post-Op Recovery

Measuring Patient Ambulation in Post-Operative Recovery

The purpose of this study is to create a platform that accurately measures and reports patient physical activity before a procedure, during the hospital stay, and after discharge from the hospital.

Study Overview

• Status: Completed
• Conditions: Physical Activity
• Intervention / Treatment: Device: RX Navigait

Detailed Description

Early ambulation in post-operative patients has shown benefits including shorter length of stay and/or fewer complications. Accelerometers have been found as useful instruments in encouraging ambulation in patients. Accelerometers are non-invasive devices that can evaluate changes in movement, gait, and ambulatory activity. Although these devices can be beneficial, little research exists on the best way to engage patients in ambulation, how to develop a standard ambulation protocol, and the best algorithms to measure ambulation post-operation. This study seeks to develop a standardized activity tracker and program that will encourage patient ambulation and allow patients and healthcare providers to view the progress of daily walking goals.

A total of 3,000 patients will be asked if they would like to participate in this study. A healthcare provider will explain to the patient the benefits of getting out of bed, sitting, and walking after an invasive procedure. Patients who decide to participate will be given an accelerometer during their pre-operation visit or after their surgery while still in the hospital. Patients will be asked to wear the accelerometer continuously during waking hours. The accelerometer will provide patients with daily walking goals, reminders of when it is time to walk, track step count, record time of walk, and duration of walk. Patients will be asked to wear the accelerometer until their post-op visit (about 30 days).

The following data points will be analyzed:

• Relationship between ambulation and patient outcomes
• Relationship between ambulation and other health factors
• Effectiveness of prototype platform to motivate and monitor patient activity

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Utah
    • Murray, Utah, United States, 84107
      • Intermountain Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients of physician study investigators

Exclusion Criteria:

• Patients whose physicians find they are unfit to participate in a walking program

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RX Navigait; Individuals in this group will be given an activity tracking device that receives and displays walking reminders and daily walking goals. In addition, they will be given additional education about the benefits of walking. The device will track daily steps taken, minutes of walking, and frequency of walking bouts throughout the day.	Device: RX Navigait; The RX Navigait is an accelerometer that tracks the number to steps taken, duration of walking, and time of walking. In addition, this device sends messages to patients regarding daily walking goals and walking reminders.
No Intervention: Control Group; Participants in this group will be given an activity tracking device that receives and displays walking reminders and daily walking goals but will not receive additional education regarding the benefits of walking. The device will track daily steps taken, minutes of walking, and frequency of walking bouts throughout the day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Patient Ambulation (number of steps, frequency, time)	Up to 3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Accuracy of accelerometer algorithms measuring post operation walking	Up to three years
Number of patients completing ambulation program	Up to three years

Collaborators and Investigators

• Sponsor: Intermountain Health Care, Inc.
• Collaborators: Savvysherpa, Inc.
• Investigators: Principal Investigator: Mark Ott, MD, Intermountain Health Care, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): July 23, 2014
• Primary Completion (Actual): October 10, 2016
• Study Completion (Actual): October 10, 2016

Study Registration Dates

• First Submitted: July 31, 2015
• First Submitted That Met QC Criteria: August 18, 2015
• First Posted (Estimate): August 19, 2015

Study Record Updates

• Last Update Posted (Actual): October 17, 2017
• Last Update Submitted That Met QC Criteria: October 13, 2017
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: accelerometer; patient ambulation
• Other Study ID Numbers: 1024875