NCT02927860

Brief Summary

Show by collecting sleep and activity data, outcomes after thoracic surgery are improved with better sleep and increased activity.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
5

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

October 1, 2016

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

October 6, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 7, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 8, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 8, 2017

Completed
Last Updated

January 9, 2019

Status Verified

January 1, 2019

Enrollment Period

10 months

First QC Date

October 6, 2016

Last Update Submit

January 7, 2019

Conditions

Thoracic SurgerySurgery, Thoracic

Keywords

sleepexerciseactivity

Outcome Measures

Primary Outcomes (1)

  • Length of Stay

    Until discharge, an average of 5 days

Secondary Outcomes (3)

  • Incidence of pneumonia while hospitalized

    Until discharge, an average of 5 days

  • Incidence of blood clot while hospitalized

    Until discharge, an average of 5 days

  • Incidence of deconditioning while hospitalized

    Until discharge, an average of 5 days

Interventions

FitbitOTHER

A FitBit HR monitor will be placed on patients when they arrive on the nursing unit after thoracic surgery. Sleep and activity will be monitored for the duration of the patient's hospitalization and the data from the Fitbit HR device will be downloaded by the study staff to a computer.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Mayo Clinic Rochester patients undergoing thoracic surgery

You may qualify if:

  • undergoing thoracic surgery at Mayo Clinic Rochester
  • expected to stay in hospital for at least 4 days
  • signed consent form

You may not qualify if:

  • Unable to provide consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Mark S Allen, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 6, 2016

First Posted

October 7, 2016

Study Start

October 1, 2016

Primary Completion

August 8, 2017

Study Completion

August 8, 2017

Last Updated

January 9, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)