- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04216238
Association of Wearable Activity Monitors With Post-Operative Activity Level Among Cardiovascular Surgical Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
While this study used participants from a general surgical floor, its merit should be translatable to the cardiovascular surgical patient population. Additionally, Thorup et al. (2016) proved a positive correlation between the amount of time a step counting device was worn and the distance walked by patients.
It is no surprise that the importance of activity level and ambulation goals are stressed as much, if not more, to cardiac surgery patients versus other surgical patients. In order to be released from the hospital, a cardiac surgery patient must meet and exceed a certain walking distance. Because of this, much of the post-operative teaching is related to the importance of ambulating, setting distance goals, and defining a walking plan to adhere to during the hospital stay and after discharge.
Early and sustained mobility in the post cardiovascular surgical patient can positively impact patient outcomes. In order to drive these outcomes, patient ownership, motivation and self-accountability beyond the walls of the hospital must be achieved.
This study will use best practice guidelines, the relationship-based care model, and innovative technology to determine if using wearable activity monitors impacts: (1) intrinsic motivation, (2) time of return to pre-operative mobility levels, (3) LOS and readmission rates, and (4) overall fitness level.
The aim of this study is to determine if use of a wearable activity monitor will motivate post cardiovascular surgical patients to increase activity levels over a 12 week period, to determine the wearable activity monitor's ability to influence return to pre-surgical self-reported mobility level, to determine if using a wearable activity monitor will increase 6 minute walk test(6MWT) distance comparing pre-discharge 6MWT and 3 month post 6MWT, to determine amicability of a wearable activity monitor as an intervention strategy in post cardiovascular surgical patients, to determine if use of a wearable activity monitor as a post-operative intervention will impact patient length of stay and/or readmission.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Texas
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Mansfield, Texas, United States, 76063
- Methodist Mansfield Medical Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patient must be at least 18 years old
- Patient must have cardiovascular surgery
- Patient must be able to ambulate without the use of an assistive device
- Patient must be able to wear activity wrist device
- Patient must speak and read English
Exclusion Criteria:
- Patient does not speak or read English
- Patient is not able to ambulate, is wheelchair bound, bed bound, or requires the use of an assistive device for ambulation
- Patient is discharged to an inpatient rehabilitation facility
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Cardiovascular surgical patients
Patients who received cardiovascular surgery and was released from the hospital due to meeting and exceeding a certain walking distance.
|
surveys to document progress
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
intrinsic motivation
Time Frame: over a period of 12 months
|
refers to behavior that is driven by internal rewards.
In other words, the motivation to engage in a behavior arises from within the individual because it is naturally satisfying.
|
over a period of 12 months
|
|
time of return to pre-operative mobility levels
Time Frame: over a period of 12 months
|
time of return to pre-operative mobility levels
|
over a period of 12 months
|
|
LOS
Time Frame: over a period of 12 months
|
LENGTH OF STAY
|
over a period of 12 months
|
|
readmission rates
Time Frame: over a period of 12 months
|
readmission rates
|
over a period of 12 months
|
|
overall fitness level
Time Frame: over a period of 12 months
|
FITNESS LEVEL
|
over a period of 12 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Brooks Williams, BSN, RN, Methodist Mansfield Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 038.NUR.2019.M
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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