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

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06397040
• Other study ID #: STUDY23110094
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2024
• Est. completion date: June 30, 2025

Study information

• Verified date: April 2024
• Source: University of Pittsburgh
• Contact: Kathryn Marchetti, MD
• Phone: 412-605-3020
• Email: marchettik[@]upmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: June 30, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• undergoing cystectomy at single center
• English speaking
• owns smart phone

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Bladder Cancer
• Quality of Life
• Urinary Bladder Neoplasms

Intervention

Device:
• 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

Locations

Country	Name	City	State
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

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