NCT04065178

Brief Summary

This preliminary study is intended to collect activity level data in a preliminary longitudinal means in order to gain more knowledge into our patient's current activity status. Our long-term objective of tracking patient activity levels in relation to function and length of stay is to identify opportunities for improved patient activity level, decreased length of stay, and increased functional mobility at discharge. The main purpose of this study is the exploration of the ability to generate meaningful activity data. Usual standard of care will be taking place during this preliminary study, there is not an intervention being studied at this time.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2018

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

Study Start

First participant enrolled

November 26, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 23, 2019

Completed
7 months until next milestone

First Posted

Study publicly available on registry

August 22, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 23, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 23, 2020

Completed
Last Updated

April 5, 2021

Status Verified

April 1, 2021

Enrollment Period

1.8 years

First QC Date

January 23, 2019

Last Update Submit

April 1, 2021

Conditions

Outcome Measures

Primary Outcomes (5)

  • Sedentary Minutes

    Sedentary minutes will be reported from the Fitbit Charge 2.

    Length of stay in the inpatient facility-will differ for each patient (expected average of 3 weeks)

  • Lightly Active Minutes

    Lightly active minutes will be reported from the Fitbit Charge 2.

    Length of stay in the inpatient facility-will differ for each patient (expected average of 3 weeks)

  • Fairly Active Minutes

    Fairly active minutes will be reported from the Fitbit Charge 2.

    Length of stay in the inpatient facility-will differ for each patient (expected average of 3 weeks)

  • Very Active Minutes

    Very active minutes will be reported from the Fitbit Charge 2.

    Length of stay in the inpatient facility-will differ for each patient (expected average of 3 weeks)

  • Minutes Asleep

    Minutes asleep will be reported from the Fitbit Charge 2.

    Length of stay in the inpatient facility-will differ for each patient (expected average of 3 weeks)

Secondary Outcomes (1)

  • Cognitive Function via the FIM Instrument

    Length of stay in the inpatient facility-will differ for each patient (expected average of 3 weeks)

Study Arms (1)

Level of Activity

Level of activity for all patients admitting to the inpatient neurological rehabilitation unit.

Behavioral: Level of activity

Interventions

Inpatients will be asked if they are willing to wear a heart rate tracking fitness watch during their stay. They will be asked quality of life questions on a questionnaire that will take approximately 30 minutes to answer at admission and discharge. At the end of the study they will return the Fitbit Charge 2 to the study coordinator or their nurse. Your rehabilitation plan of care will not change in any other way.

Level of Activity

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients admitting to the Inpatient Neurological Specialty Unit (a rehab unit)

You may qualify if:

  • English as a first speaking language
  • willingness to participate (family consent if patient is not able to consent)
  • ability to wear a heart rate tracking device during full admission
  • intact skin integrity of the arms
  • commercial insurance or government insurance (medicare or medicaid)
  • an estimated length of stay greater than 5 days and less than 5 weeks at initial assessment by the admitting team

You may not qualify if:

  • patients with multiple sclerosis (MS), brain tumors, or degenerative neurological disorders
  • patients with a pacemaker, left ventricular assist device, or with ventilator support
  • patients without health insurance in place
  • non-primary English speaking
  • patients who require 1:1 supervision as they are deemed unable to comply with device wearing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Intermountain Medical Center

Salt Lake City, Utah, 84107, United States

Location

Study Officials

  • Kelli Cooper, PT, DPT, NCS

    Intermountain Health Care, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 23, 2019

First Posted

August 22, 2019

Study Start

November 26, 2018

Primary Completion

September 23, 2020

Study Completion

September 23, 2020

Last Updated

April 5, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations