Real-time Location System Feasibility Study

Study Overview
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Brief Summary
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The proposed study will investigate the feasibility of using the Wake Forest Real-time Location System (RTLS) in monitoring patient movement during their in-hospital postoperative recovery. The study will involve patients who have undergone surgery requiring inpatient admission to the 9CC surgical ward. Actual patient movement will be monitored during their postoperative recovery and compared with data recorded by the Wake Forest location system. In this small pilot study, a subgroup of participants will be randomized to two cohorts, continuous walking and interval walking. Tolerability of the varied walking intensity will be measured.

Official Title
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Real-time Location System Feasibility Study Part 2

Conditions
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Surgery, Mobility

Intervention / Treatment
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* Behavioral: Ambulation


Participation Criteria
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Eligibility Criteria
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Inclusion criteria Male or female patients between the ages of 18 and 90. Admitted to 9cc. Recovering from surgery. Ability to understand and the willingness to sign an IRB-approved informed consent document. Ability to understand and complete the study survey instruments in English. Exclusion criteria Non-surgical patient. Emergency surgical procedure. Anticipated discharge less than 24 hour. Unable to ambulate or ambulation not permitted by treating provider. Unable to understand and complete the study survey instruments in English. Post-operative complications that in the opinion of the study investigator would impair the ability of the patient to adhere to the study procedures.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Continuous Ambulation<br>The total distance will be 40 meters. Study team members will walk, support, and coach the subject to walk as slow as he/she wants | Behavioral: Ambulation<br>* Variation in ambulatory intensity.<br>|
| Active Comparator: Interval Ambulation<br>The subject will walk a total distance of 40 meters. This distance will be divided into four intervals of 10 meters to equal the same measured distance as the continuous group. The subject will receive two minutes of rest between each interval and will be supported and coached to walk as fast as they can. | Behavioral: Ambulation<br>* Variation in ambulatory intensity.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characterize patient tolerability continuous vs interval 40m walk using perceived exertion scale (1-10). | Characterize patient tolerability continuous vs interval 40m walk using rated perceived exertion (RPE) scale (1-10). RPE is a self-reported measure of exercise intensity with 10 being strenuous activity. | 1 day | 
| Evaluate surgical patient discharge readiness using a questionnaire. | Questionnaire has 3 parts. 1) Self-Efficacy Survey which has a raw summed score ranging from 10-40 that is converted to a T-score. T scores are standard scores in which 50 represents the mean of the US general population (based on the 2010 Census) and 10 represents the general population standard deviation. For the NIH Toolbox Self-Efficacy Survey, higher scores are indicative of more general self-efficacy. Scores 1 SD or more below the mean (T ≤ 40) suggest low levels of general self-efficacy and scores 1 SD or more above the mean (T ≥ 60) suggest high levels of general self-efficacy. T-scores ≤ 40 may warrant heightened surveillance or concern. 2) Ambulatory Self-Confidence Questionnaire (Asano et al 2007) which measures ambulatory confidence on a 1-10 scale with 10 being very confident. 3) 5 specific questions measured on Likert scale (1-5) regarding readiness for discharge after surgery. Higher number indicating personal perception of ready for leaving hospital. | 1 day |