The Use of Remote Monitoring to Improve Patient-Reported Outcomes and Readmission Rates Following Radical Cystectomy
NCT ID: NCT06397040
Last Updated: 2025-11-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
38 participants
INTERVENTIONAL
2024-10-01
2025-06-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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remote monitoring without provider feedback
remote monitoring with FitBit device and daily patient-reported outcome assessment, without real-time provider feedback
participant monitoring of remote data
participant monitoring of remote data, based upon post-operative instructions
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
provider monitoring and feedback to remote data
provider monitoring of remote data and feedback to changes in remote data
participant monitoring of remote data
participant monitoring of remote data, based upon post-operative instructions
Interventions
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provider monitoring and feedback to remote data
provider monitoring of remote data and feedback to changes in remote data
participant monitoring of remote data
participant monitoring of remote data, based upon post-operative instructions
Eligibility Criteria
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Inclusion Criteria
* English speaking
* owns smart phone
Exclusion Criteria
* non-English speaking
* does not own smart phone
18 Years
ALL
No
Sponsors
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University of Pittsburgh
OTHER
Responsible Party
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Bruce Jacobs
Associate Professor
Principal Investigators
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Kathryn Marchetti, MD
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh Medical Center
Locations
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University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Countries
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Other Identifiers
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STUDY23110094
Identifier Type: -
Identifier Source: org_study_id
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