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Trial Title:
The Use of Remote Monitoring to Improve Patient-Reported Outcomes and Readmission Rates Following Radical Cystectomy
NCT ID:
NCT06397040
Condition:
Bladder Cancer
Quality of Life
Conditions: Official terms:
Urinary Bladder Neoplasms
Conditions: Keywords:
bladder cancer
remote monitoring
quality of life
cystectomy
Study type:
Interventional
Study phase:
N/A
Overall status:
Enrolling by invitation
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
provider monitoring and feedback to remote data
Description:
provider monitoring of remote data and feedback to changes in remote data
Arm group label:
remote monitoring with provider feedback
Intervention type:
Device
Intervention name:
participant monitoring of remote data
Description:
participant monitoring of remote data, based upon post-operative instructions
Arm group label:
remote monitoring with provider feedback
Arm group label:
remote monitoring without provider feedback
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Pittsburgh Medical Center
Address:
City:
Pittsburgh
Zip:
15232
Country:
United States
Start date:
October 1, 2024
Completion date:
June 30, 2025
Lead sponsor:
Agency:
University of Pittsburgh
Agency class:
Other
Source:
University of Pittsburgh
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06397040
