NCT04216238

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 12, 2019

Completed
1 day until next milestone

Study Start

First participant enrolled

August 13, 2019

Completed
5 months until next milestone

First Posted

Study publicly available on registry

January 2, 2020

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 24, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 24, 2022

Completed
Last Updated

March 23, 2026

Status Verified

February 1, 2023

Enrollment Period

2.8 years

First QC Date

August 12, 2019

Last Update Submit

March 19, 2026

Conditions

Keywords

cardiovascular surgical patient

Outcome Measures

Primary Outcomes (5)

  • 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

  • time of return to pre-operative mobility levels

    time of return to pre-operative mobility levels

    over a period of 12 months

  • LOS

    LENGTH OF STAY

    over a period of 12 months

  • readmission rates

    readmission rates

    over a period of 12 months

  • overall fitness level

    FITNESS LEVEL

    over a period of 12 months

Study Arms (1)

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

Interventions

surveys to document progress

Cardiovascular surgical patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Methodist Mansfield Medical Center

Mansfield, Texas, 76063, United States

Location

Study Officials

  • Brooks Williams, BSN, RN

    Methodist Mansfield Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2019

First Posted

January 2, 2020

Study Start

August 13, 2019

Primary Completion

May 24, 2022

Study Completion

May 24, 2022

Last Updated

March 23, 2026

Record last verified: 2023-02

Locations