Clinical trial · Interventional
Use of Wearables Following Cystectomy- Part II
The Feasibility of Using Wearable Electronic Devices Following Cystectomy to Identify Early Biometric Signatures of Readmission
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 9, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260909-000002
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
| Cystectomy | — | UNRESOLVED | — |
| Neurogenic Bladder Disorder | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fitbit Sense 2 | Device | — | UNRESOLVED |
| Smartphone application survey | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Fitbit Sense 2 + smartphone surveys
- description
- 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.
- interventionNames
- Device: Fitbit Sense 2
- Other: Smartphone application survey
Primary outcomes (2)
- measure
- Proportion of participants who remain in the study from enrollment until trial completion (participant retention)
- timeFrame
- From enrollment to 30 days post-discharge following cystectomy hospitalization
- measure
- Participant wearable electronic device adherence
- timeFrame
- From day of discharge following cystectomy hospitalization to 30 days post-discharge
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available