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Patient Ambulation in Post-Op Recovery

NCT ID: NCT02528669

Last Updated: 2017-10-17

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

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-23

Study Completion Date

2016-10-10

Brief Summary

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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.

Detailed Description

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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

Conditions

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Physical Activity

Keywords

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accelerometer patient ambulation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

RX Navigait

Intervention Type DEVICE

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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients of physician study investigators

Exclusion Criteria

* Patients whose physicians find they are unfit to participate in a walking program
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Savvysherpa, Inc.

INDUSTRY

Sponsor Role collaborator

Intermountain Health Care, Inc.

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mark Ott, MD

Role: PRINCIPAL_INVESTIGATOR

Intermountain Health Care, Inc.

Locations

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Intermountain Medical Center

Murray, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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1024875

Identifier Type: -

Identifier Source: org_study_id