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

Sponsor
Methodist Health System (Other)
Overall Status
Recruiting
CT.gov ID
NCT04216238
Collaborator
(none)
100
1
35.6
2.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: quasi-experimental Pre-test/Post-test design

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 Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Association of Wearable Activity Monitors With Post-Operative Activity Level Among Cardiovascular Surgical Patients
Actual Study Start Date :
Aug 13, 2019
Anticipated Primary Completion Date :
Aug 1, 2022
Anticipated Study Completion Date :
Aug 1, 2022

Arms and Interventions

Arm 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.

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

Outcome Measures

Primary Outcome Measures

  1. intrinsic motivation [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.

  2. time of return to pre-operative mobility levels [over a period of 12 months]

    time of return to pre-operative mobility levels

  3. LOS [over a period of 12 months]

    LENGTH OF STAY

  4. readmission rates [over a period of 12 months]

    readmission rates

  5. overall fitness level [over a period of 12 months]

    FITNESS LEVEL

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Methodist Mansfield Medical Center Mansfield Texas United States 76063

Sponsors and Collaborators

  • Methodist Health System

Investigators

  • Principal Investigator: Brooks Williams, BSN, RN, Methodist Mansfield Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Methodist Health System
ClinicalTrials.gov Identifier:
NCT04216238
Other Study ID Numbers:
  • 038.NUR.2019.M
First Posted:
Jan 2, 2020
Last Update Posted:
Dec 10, 2021
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Methodist Health System

Study Results

No Results Posted as of Dec 10, 2021