Use of Wearables Following Cystectomy- Part II

University of Pittsburgh

Status: Invitation-only

Conditions: Bladder Cancer; Cystectomy; Neurogenic Bladder Disorder

Treatments: Other: Smartphone application survey; Device: Fitbit Sense 2

Study type: Interventional

Funder types: Other

Identifiers

NCT07148765

STUDY25060009

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Fitbit Sense 2 + smartphone surveys

Experimental group

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.

Treatment:

Device: Fitbit Sense 2

Other: Smartphone application survey