Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT07148765

Use of Wearables Following Cystectomy- Part II

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.

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Conditions

Bladder Cancer Cystectomy Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neoplasms Neoplasms by Site Nervous System Diseases Neurogenic Bladder Disorder Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urinary Bladder Neoplasms Urinary Bladder, Neurogenic Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UPMC

Pittsburgh, Pennsylvania, 15232, United States

About this study

Cystectomy is associated with high rates of complications and readmissions, with approximately one-quarter of patients readmitted within 30 days. Despite advances in perioperative care, these rates have remained unchanged. Remote patient monitoring using a combination of consumer-grade wearable electronic devices, such as the Fitbit Sense 2, and smartphone application administered questionnaires offers an accessible method for continuous, passive collection of digital biomarkers (e.g., heart rate, respiratory rate, SpO2, step count, sleep patterns) and collection of patient-reported outcomes (PROs) in the outpatient setting. Prior studies have demonstrated the feasibility of wearable devices and electronic PRO monitoring postoperatively, but limited data exist on the real-time use of biomarker and PRO data to trigger provider responses in cystectomy patients following discharge.

The investigators' primary objective is to evaluate the feasibility of investigating continuous remote monitoring using wearable electronic devices and smartphone application-administered questionnaires to trigger real-time alerts to abnormalities in digital biomarkers and PROs in the 30-day postoperative period following cystectomy. The secondary objective of this study is to identify early biometric signatures predictive of adverse events that lead to readmissions.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • English-speaking
  • Owns a smartphone
  • Scheduled to undergo cystectomy with urinary diversion at a UPMC hospital

Exclusion criteria

  • No reliable internet access
  • Concurrent enrollment in another interventional study that may interfere with outcomes

Treatment and study plan

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.

Primary outcomes

  1. 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

  2. Participant wearable electronic device adherence

    Time frame: From day of discharge following cystectomy hospitalization to 30 days post-discharge

    Proportion of patients who wear and transmit data from the provided Fitbit Sense 2 device for at least 16 hours per day for more 14 days

Secondary outcomes

  1. Number of participants readmitted

    Time frame: from discharge following cystectomy hospitalization to 30-days post-discharge

  2. Number of participant unplanned encounters

    Time frame: From time of discharge following cystectomy hospitalization to 30 days post-discharge

    Any unscheduled interaction with healthcare provider triggered by either the patient or a healthcare provider, including initiated by study alerts. This includes emergency department visits, telemedicine visits, telephone encounters, urgent care visits, unscheduled outpatient clinic visits, and hospital readmissions.

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Registry information

Official study title

The Feasibility of Using Wearable Electronic Devices Following Cystectomy to Identify Early Biometric Signatures of Readmission

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 29, 2025
Registry last updated
Sep 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.