Clinical trial NCT04216238: Association of Wearable Activity Monitors With Post-Operative Activity Level Among Cardiovascular Surgical Patients
Official title: Association of Wearable Activity Monitors With Post-Operative Activity Level Among Cardiovascular Surgical Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular
Keywords: cardiovascular surgical patient
Lead sponsor: Methodist Health System
Sponsor class: OTHER
First posted: 2020-01-02
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cardiovascular surgical patients will be recruited preoperatively for participation in study with an anticipated three month time commitment. Upon informed consent, participant will receive pre-test and wearable activity monitor hardware from study investigator. The 6 minute walk test will be conducted prior to discharge from the hospital and again during the three month follow-up visit along with the post-test survey.

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: intrinsic motivation
timeFrame: over a period of 12 months
measure: time of return to pre-operative mobility levels
timeFrame: over a period of 12 months
measure: LOS
timeFrame: over a period of 12 months
measure: readmission rates
timeFrame: over a period of 12 months
measure: overall fitness level
timeFrame: over a period of 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Mansfield
country: United States
facility: Methodist Mansfield Medical Center
state: Texas
Study officials:
affiliation: Methodist Mansfield Medical Center
name: Brooks Williams, BSN, RN
role: PRINCIPAL_INVESTIGATOR
References: