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

NCT06397040 | Completed

• 1 other identifier: STUDY23110094
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bladder Cancer; Quality of Life

Keywords

bladder cancer; remote monitoring; quality of life; cystectomy

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

remote monitoring without provider feedback

EXPERIMENTAL

remote monitoring with FitBit device and daily patient-reported outcome assessment, without real-time provider feedback

Device: participant monitoring of remote data

remote monitoring with provider feedback

EXPERIMENTAL

remote monitoring with FitBit device and daily patient-reported outcome assessment, as well as real-time provider feedback in response to remote data

Device: provider monitoring and feedback to remote data; Device: participant monitoring of remote data

Interventions

provider monitoring and feedback to remote data DEVICE

provider monitoring of remote data and feedback to changes in remote data

remote monitoring with provider feedback

participant monitoring of remote data DEVICE

participant monitoring of remote data, based upon post-operative instructions

remote monitoring with provider feedback; remote monitoring without provider feedback

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15232, United States

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Kathryn Marchetti, MD

  University of Pittsburgh Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 23, 2024
• First Posted: May 2, 2024
• Study Start: October 1, 2024
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: November 5, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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.
• Access Criteria: Interested researcher can contact the study team for individual participant data. The data will be made available following data use agreement.

Locations

US (1)