Clinical trial NCT02528669: Patient Ambulation in Post-Op Recovery
Official title: Measuring Patient Ambulation in Post-Operative Recovery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity
Keywords: accelerometer
patient ambulation
Lead sponsor: Intermountain Health Care, Inc.
Sponsor class: OTHER
Collaborators: name: Savvysherpa, Inc.
First posted: 2015-08-19
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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: 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

Eligibility criteria: Inclusion Criteria:

* Patients of physician study investigators

Exclusion Criteria:

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

Primary outcomes:
measure: Patient Ambulation (number of steps, frequency, time)
timeFrame: Up to 3 months
Secondary outcomes:
measure: Accuracy of accelerometer algorithms measuring post operation walking
timeFrame: Up to three years
measure: Number of patients completing ambulation program
timeFrame: Up to three years
Other outcomes:
Locations:
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
Study officials:
affiliation: Intermountain Health Care, Inc.
name: Mark Ott, MD
role: PRINCIPAL_INVESTIGATOR
References: