NCT04348981

Brief Summary

The aim of this study is to detect decreased patient activity level after discharge after cardiac surgery to prevent readmissions. Cardiac surgery is associated with a high chance of readmission within 30 days, common reasons being volume overload, arrhythmia, pulmonary complications, and infections. A decreased activity level often precedes those complications. Measuring patient activity levels using wearable activity trackers (Fitbit) may detect complications early and prompts the surgical team to contact the patient before a visit to the Emergency Room is warranted.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2020

Typical duration for not_applicable

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 13, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 16, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2020

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2022

Completed
Last Updated

March 14, 2022

Status Verified

February 1, 2022

Enrollment Period

2.1 years

First QC Date

April 13, 2020

Last Update Submit

February 28, 2022

Conditions

Cardiac SurgeryEnhanced Recovery

Keywords

Enhanced RecoveryCardiac SurgeryElectivewearableactivityreadmission

Outcome Measures

Primary Outcomes (1)

  • Readmission

    decreased level of activity may precede readmission

    30 days after surgery

Study Arms (1)

Wearable

EXPERIMENTAL

All patients eligible to enroll in the Enhanced Recovery after Cardiac Surgery pathway will be offered a wearable fitness tracking device.

Device: Wearable fitness tracking device

Interventions

Wearable fitness tracking deviceDEVICE

Patients having a wearable fitness tracking device will be monitored for their level of activity after surgery. Declines in activity level will prompt a phone call from the surgical provider.

Wearable

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing cardiac surgery participating under the ERAS cardiac surgery protocol

You may not qualify if:

  • Patient refusal of device
  • Patients with skin reactions to wearable devices (contact dermatitis)
  • upper extremity swelling
  • upper extremity deep vein thrombosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Dirk Varelmann, MD

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Anesthesiologist

Study Record Dates

First Submitted

April 13, 2020

First Posted

April 16, 2020

Study Start

June 1, 2020

Primary Completion

June 30, 2022

Study Completion

July 31, 2022

Last Updated

March 14, 2022

Record last verified: 2022-02