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OpenTrials
Completed

NCT Number: NCT06397040

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15232, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

provider monitoring and feedback to remote data

Device

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

participant monitoring of remote data

Device

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

Primary outcomes

  1. patient engagement

    Time frame: 4 weeks following hospital discharge

    percent of patients who utilized the application daily and wore the device for 8hrs daily

  2. provider response

    Time frame: 4 weeks following hospital discharge

    time from alert to provider response to patient

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Registry information

Acronym: WATCH

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 2, 2024
Registry last updated
Nov 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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