Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06397040
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-05-02
First Post:
2024-04-23
Brief Title:
The Use of Remote Monitoring to Improve Patient-Reported Outcomes and Readmission Rates Following Radical Cystectomy
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
The Use of Remote Monitoring to Improve Patient-Reported Outcomes and Readmission Rates Following Radical Cystectomy
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None