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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:
Participants will
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants who remain in the study from enrollment until trial completion (participant retention) | 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 | From day of discharge following cystectomy hospitalization to 30 days post-discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants readmitted | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthew R Epstein, MD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UPMC | Pittsburgh | Pennsylvania | 15232 | United States |
All IPD that underlie results in a publication
The data will be available at the time of publication and 7 years following (as data stored at institution for 7 years following project completion).
Interested researcher can contact the study team for any purpose. Individual participant data to researchers who provide a methodologically sound proposal. The data will be made available following a data use agreement.
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| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| D001750 | Urinary Bladder, Neurogenic |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| 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. |
|
| From time of discharge following cystectomy hospitalization to 30 days post-discharge |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |