Association of Wearable Activity Monitors With Post-Operative Activity Level Among Cardiovascular Surgical Patients

Cardiovascular Clinical Trial

Official title:

Association of Wearable Activity Monitors With Post-Operative Activity Level Among Cardiovascular Surgical Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04216238
• Other study ID #: 038.NUR.2019.M
• Status: Completed
• Start date: August 13, 2019
• Est. completion date: May 24, 2022

Study information

• Verified date: February 2023
• Source: Methodist Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Early mobility in the post cardiovascular surgical patient can dramatically impact patient outcomes. Utilizing an innovative strategy, like a wearable activity monitor, can potentially provide: accurate data on post-operative mobility level; increased motivation and self-efficacy in the recovering patient; data to potentially drive post-operative mobility goal setting. Use of a wearable activity monitor will reduce time needed to return to pre-operative activity level in the cardiovascular surgical patient.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: May 24, 2022
• Est. primary completion date: May 24, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular

Intervention

Behavioral:
• quasi-experimental Pre-test/Post-test design
surveys to document progress

Locations

Country	Name	City	State
United States	Methodist Mansfield Medical Center	Mansfield	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Methodist Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	intrinsic motivation	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
Primary	time of return to pre-operative mobility levels	time of return to pre-operative mobility levels	over a period of 12 months
Primary	LOS	LENGTH OF STAY	over a period of 12 months
Primary	readmission rates	readmission rates	over a period of 12 months
Primary	overall fitness level	FITNESS LEVEL	over a period of 12 months