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

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-01

Study Completion Date

2025-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Bladder Cancer Quality of Life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

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

Group Type EXPERIMENTAL

participant monitoring of remote data

Intervention Type DEVICE

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

Group Type EXPERIMENTAL

provider monitoring and feedback to remote data

Intervention Type DEVICE

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

participant monitoring of remote data

Intervention Type DEVICE

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

Intervention Type DEVICE

participant monitoring of remote data

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Pittsburgh

OTHER

Sponsor Role lead

Responsible Party

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Bruce Jacobs

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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United States

Other Identifiers

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STUDY23110094

Identifier Type: -

Identifier Source: org_study_id

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