Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| remote monitoring without provider feedback | Experimental | remote monitoring with FitBit device and daily patient-reported outcome assessment, without real-time provider feedback |
|
| remote monitoring with provider feedback | Experimental | remote monitoring with FitBit device and daily patient-reported outcome assessment, as well as real-time provider feedback in response to remote data |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| provider monitoring and feedback to remote data | Device | provider monitoring of remote data and feedback to changes in remote data |
|
| Measure | Description | Time Frame |
|---|---|---|
| patient engagement | percent of patients who utilized the application daily and wore the device for 8hrs daily | 4 weeks following hospital discharge |
| provider response | time from alert to provider response to patient | 4 weeks following hospital discharge |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kathryn Marchetti, MD | University of Pittsburgh Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15232 | United States |
all IPD that underlie results in a publication
The data will be available at the time of publication and 7 years following (as data stored at institution for 7 years following project completion.
Interested researcher can contact the study team for individual participant data. The data will be made available following data use agreement.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| participant monitoring of remote data | Device | participant monitoring of remote data, based upon post-operative instructions |
|
| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided