Bladder CancerNCT07148765
Use of Wearables Following Cystectomy- Part II
A study testing Fitbit Sense 2 and Smartphone application survey in people with Bladder Cancer and Neurogenic Bladder Disorder, run by University of Pittsburgh at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer, Neurogenic Bladder Disorder, Cystectomy
- What is being tested?
- Fitbit Sense 2 and Smartphone application survey
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Sep 2025to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- English-speaking
- Owns a smartphone
- Scheduled to undergo cystectomy with urinary diversion at a UPMC hospital
Who cannot join
- No reliable internet access
- Concurrent enrollment in another interventional study that may interfere with outcomes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Feasibility of Using Wearable Electronic Devices Following Cystectomy to Identify Early Biometric Signatures of Readmission
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:
Read more
- 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.
Read the detailed description
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.
- Conditions
- Bladder Cancer, Neurogenic Bladder Disorder, Cystectomy
- Being tested
- Fitbit Sense 2, Smartphone application survey
- Keywords
- Wearable Electronic Devices, Patient Reported Outcome Measures, Postoperative Care, Remote Monitoring, Cystectomy, Urinary Diversion, Fitbit
- Medical subject headings
- Urinary Bladder Neoplasms, Urinary Bladder, Neurogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fitbit Sense 2Device
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 surveyOther
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 group | Role | What they receive |
|---|---|---|
| Fitbit Sense 2 + smartphone surveys | Experimental | 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. Receives: Device: Fitbit Sense 2; Other: Smartphone application survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants who remain in the study from enrollment until trial completion (participant retention)
Measured: From enrollment to 30 days post-discharge following cystectomy hospitalization
Participant wearable electronic device adherence
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
Measured: From day of discharge following cystectomy hospitalization to 30 days post-discharge
Secondary outcomes (2)
Number of participants readmitted
Measured: from discharge following cystectomy hospitalization to 30-days post-discharge
Number of participant unplanned encounters
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.
Measured: From time of discharge following cystectomy hospitalization to 30 days post-discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2025
- Study start19 Sep 2025
- Primary completion17 Jun 2026
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bruce Jacobs, University of Pittsburgh
- Investigators
- Bruce Jacobs, MD, MPH, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07148765
- Sponsor's protocol ID
- STUDY25060009
- Status last verified
- Sep 2026
- First submitted
- 22 Aug 2025
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility of Using Wearable Electronic Devices Following Cystectomy to Identify Early Biometric Signatures of Readmission
- ClinicalTrials.gov ID
- NCT07148765
- Acronym / sponsor ID
- STUDY25060009
- Conditions
- Bladder Cancer, Neurogenic Bladder Disorder, Cystectomy
- Keywords
- Wearable Electronic Devices, Patient Reported Outcome Measures, Postoperative Care, Remote Monitoring, Cystectomy, Urinary Diversion, Fitbit
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- 19 Sep 2025 (actual)
- Primary completion
- 17 Jun 2026 (actual)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 29 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fitbit Sense 2 + smartphone surveys | Experimental | Device: Fitbit Sense 2, Other: Smartphone application surveyParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- English-speaking
- Owns a smartphone
- Scheduled to undergo cystectomy with urinary diversion at a UPMC hospital
Key exclusion criteria (2 listed)
- No reliable internet access
- Concurrent enrollment in another interventional study that may interfere with outcomes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fitbit Sense 2Continuous 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. | Device | Fitbit Sense 2 + smartphone surveys |
| Smartphone application surveyDaily 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. | Other | Fitbit Sense 2 + smartphone surveys |
Primary outcome
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
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
2 secondary outcomes
Number of participants readmitted
Time frame: from discharge following cystectomy hospitalization to 30-days post-discharge
Number of participant unplanned encounters
Time frame: From time of discharge following cystectomy hospitalization to 30 days post-discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruce Jacobs, MD, MPH principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fitbit Sense 2 and Smartphone application survey in people with Bladder Cancer and Neurogenic Bladder Disorder, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.