Use of Wearables Following Cystectomy- Part II

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
University of Pittsburgh
Study ID
NCT07148765
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Fitbit Sense 2 — DEVICE
    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.
  • Smartphone application survey — OTHER
    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.

Study Details

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.

Key Dates

Start date
Sep 19, 2025
Status verified
Sep 2025
Primary completion
Jun 30, 2026
Completion
Sep 1, 2026

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Fitbit Sense 2 + smartphone surveys
    Participants undergoing remote monitoring following cystectomy using Fitbit sense 2 device for continuous biometric marker collection and transmission and completion of daily PRO questionnaires administered via smartphone application to trigger provider response within 24 hours of predefined threshold abnormalities.

Primary Outcome Measure

Proportion of participants who remain in the study from enrollment until trial completion (participant retention) [ Time Frame: From enrollment to 30 days post-discharge following cystectomy hospitalization ]

Locations (1)

FacilityCityStateZIPSite coordinators
UPMCPittsburghPennsylvania15232-

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