MedTrace Logo

Use of Wearables Following Cystectomy- Part II

NCT07148765 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-09-26

No results posted yet for this study

Summary

The goal of this observational study is to learn about the practical considerations for having health care providers respond in real-time to abnormalities detected remotely for patients recovering from cystectomy following discharge from the hospital. Participants will be asked to wear a wearable fitness tracker (e.g., Fitbit) and answer a daily brief questionnaire on their smartphone.

The main question\[s\] the investigators aims to answer are:

* Is it practical to have health care providers respond in real-time to abnormal biomarkers collected using fitness trackers for patients recovering from cystectomy?
* Can we identify early biomarker signatures (e.g. using heart rate, pulse oximetry, respiratory rate, etc.) that can predict adverse events that lead to hospital readmissions?

Participants will

* Set up and use a Fitbit Sense 2 device for up to 2 weeks prior to surgery and again for 30 days following discharge after their surgical hospitalization.
* Download and complete questionnaires in a smartphone application for up to 2 weeks prior to surgery and again for 30 days following discharge after their surgical hospitalization.
* Trigger automated alerts when abnormal biometric data (from the Fitbit device) or concerning survey responses are detected.
* Receive contact from a health care provider within 24 hours of an automated alert being generated.

Conditions

Interventions

DEVICE

Fitbit Sense 2

Continuous biometric monitoring (e.g., heart rate, pulse oximetry, respiratory rate, etc.) that will trigger alerts based on predefined threshold criteria for health care providers to respond to by contacting patients within 24 hours of alert.

OTHER

Smartphone application survey

Daily questionnaire to record PROs will be administered via patient smartphones. Concerning PROs will trigger alerts which health care providers will respond to by contacting patients within 24 hours of alert.

Sponsors & Collaborators

  • University of Pittsburgh

    lead OTHER

Principal Investigators

  • Matthew R Epstein, MD · University of Pittsburgh

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-19
Primary Completion
2026-06-30
Completion
2026-09-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07148765 on ClinicalTrials.gov