The Use of Remote Monitoring to Improve Patient-Reported Outcomes and Readmission Rates Following Radical Cystectomy (WATCH)

Following radical cystectomy for bladder cancer, nearly two-thirds of patients experience a complication and almost a third are readmitted. Thus, intensified monitoring of this vulnerable group represents an opportunity for improved quality of care in the post-operative setting. By gathering biomarkers passively and continuously, wearable activity monitors augment remote patient monitoring. Further, they facilitate the collection of patient-reported outcomes frequently.

Despite the proven impact of remote monitoring on patient care, there is limited data on the feasibility and impact of employing this technology to trigger real-time provider assessment following cystectomy. The investigators plan to conduct a randomized control trial examining such. The intervention group of participants will receive continuous biomarker monitoring via FitBits and daily patient-reported outcome assessments via connected smartphones. Abnormalities in remote data will trigger automated alerts to providers. Providers will respond in real-time to these alerts and patients will receive education materials discussing preventative measures to mitigate the main risk factors for readmissions. The investigators will evaluate the feasibility of integrating this technology into the post-operative period, as well as the impact of real-time provider attention to abnormal remote data on patient-reported outcomes and rates of readmission. The investigators hypothesize that early assessment of and intervention on remote abnormalities will promote the use of outpatient or reduced intensity therapies, such as oral antibiotics or oral hydration, thus curtailing the severity of patient symptoms, intensity of complications, and need for hospitalizations. Ultimately, this trial builds upon prior research, applying patient-centered technology to improve the quality of care following cystectomy.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Bladder Cancer
• Intervention / Treatment: Device: participant monitoring of remote data; Device: provider monitoring and feedback to remote data

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15232
      • University of Pittsburgh Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• undergoing cystectomy at three hospitals within the University of Pittsburgh Medical Center system
• English speaking
• owns smart phone

Exclusion Criteria:

• unwilling or unable to participate
• non-English speaking
• does not own smart phone

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: remote monitoring without provider feedback; remote monitoring with FitBit device and daily patient-reported outcome assessment, without real-time provider feedback	Device: participant monitoring of remote data; participant monitoring of remote data, based upon post-operative instructions
Experimental: remote monitoring with provider feedback; remote monitoring with FitBit device and daily patient-reported outcome assessment, as well as real-time provider feedback in response to remote data	Device: participant monitoring of remote data; participant monitoring of remote data, based upon post-operative instructions; Device: provider monitoring and feedback to remote data; provider monitoring of remote data and feedback to changes in remote data

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
patient engagement	percent of patients who utilized the application daily and wore the device for 8hrs daily	4 weeks following hospital discharge
provider response	time from alert to provider response to patient	4 weeks following hospital discharge

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Investigators: Principal Investigator: Kathryn Marchetti, MD, University of Pittsburgh Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2024
• Primary Completion (Actual): June 30, 2025
• Study Completion (Actual): June 30, 2025

Study Registration Dates

• First Submitted: April 23, 2024
• First Submitted That Met QC Criteria: April 29, 2024
• First Posted (Actual): May 2, 2024

Study Record Updates

• Last Update Posted (Estimated): November 5, 2025
• Last Update Submitted That Met QC Criteria: November 3, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: quality of life; bladder cancer; remote monitoring; cystectomy
• Additional Relevant MeSH Terms: Urogenital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urologic Neoplasms; Urinary Bladder Diseases; Urinary Bladder Neoplasms
• Other Study ID Numbers: STUDY23110094

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: all IPD that underlie results in a publication
• IPD Sharing Time Frame: 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.
• IPD Sharing Access Criteria: Interested researcher can contact the study team for individual participant data. The data will be made available following data use agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No