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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04216238
Recruitment Status : Recruiting
First Posted : January 2, 2020
Last Update Posted : January 2, 2020
Sponsor:
Information provided by (Responsible Party):
Methodist Health System

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
Cardiovascular 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.

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Study Type : Observational
Estimated 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 : August 13, 2019
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2022

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




Primary Outcome Measures :
  1. 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.

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

  3. LOS [ Time Frame: over a period of 12 months ]
    LENGTH OF STAY

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

  5. overall fitness level [ Time Frame: over a period of 12 months ]
    FITNESS LEVEL



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04216238


Contacts
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Contact: Crystee Cooper, DHEd 214-947-1280 CrysteeCooper@mhd.com
Contact: Jordania L Lilly, MEd 214-947-1280 JordaniaLilly@mhd.com

Locations
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United States, Texas
Methodist Mansfield Medical Center Recruiting
Mansfield, Texas, United States, 76063
Contact: Laura Sweatt, RN    682-242-2450    LauraSweatt@mhd.com   
Principal Investigator: Brooks Williams, BSN, RN         
Sponsors and Collaborators
Methodist Health System
Investigators
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Principal Investigator: Brooks Williams, BSN, RN Methodist Mansfield Medical Center
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Responsible Party: Methodist Health System
ClinicalTrials.gov Identifier: NCT04216238    
Other Study ID Numbers: 038.NUR.2019.M
First Posted: January 2, 2020    Key Record Dates
Last Update Posted: January 2, 2020
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Methodist Health System:
cardiovascular surgical patient