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Trial Title:
CLEAR Care Companion Application
NCT ID:
NCT05578898
Condition:
Bladder Cancer
Radical Cystectomy
Conditions: Official terms:
Urinary Bladder Neoplasms
Conditions: Keywords:
Mobile application
Post surgical care
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
CLEAR Care Companion (CC) application
Description:
The CLEAR CC application is an EPIC-based, electronic application, downloaded to the
patient's Smartphone or Tablet. The CLEAR CC leverages patient-reported symptoms
assessment vis-a-vis push notifications to complete clinically meaningful questions and
validated questionnaires pertaining to symptoms that serve as early indicators of
readmission. The CLEAR CC application will send notifications beginning two days prior to
surgery and continue until the 6 week post operative appointment.
Arm group label:
CLEAR CC
Summary:
Hospital readmissions are common after major cancer surgery, leading to poorer patient
outcomes, increased mortality and additional costs. In this study, Clinical and
Engineering Approaches to Readmission (CLEAR) Care Companion Application, investigators
aim to utilize a smartphone application that tracks concerning postoperative symptoms and
provides educational interventions to determine if this can minimize delays in
communication between patients and medical providers, increase patient satisfaction with
the care received, and reduce or lessen the severity of readmissions.
Detailed description:
Patients complete clinically meaningful questions and validated questionnaires pertaining
to physiological and psychological symptoms that serve as early indicators of
readmission, with the aim to improve experience by empowering patient to be active
participants in their recovery, identify complications early to minimize morbidity and
reduce overall readmissions.
The study has the following three objectives: (1) Assess patient engagement with the
CLEAR Care Companion application for patients that have undergone radical cystectomy (2)
Measure patient experience with the application and its effect on satisfaction with
overall care (3) Evaluate the effect of the application on case complexity (readmission
intensity) and overall readmission rates.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patients undergoing a radical cystectomy with reconstruction through GU Oncology
Clinic
- Patient at the University of Michigan (Michigan Medicine)
- Access to compatible smartphone or tablet device
Exclusion Criteria:
- Non-English speaking patients
- Patients without access to a smart phone or tablet with internet capacity
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Michigan Rogel Cancer Center
Address:
City:
Ann Arbor
Zip:
48109
Country:
United States
Status:
Recruiting
Contact:
Last name:
Cancer AnswerLine
Phone:
800-865-1125
Email:
CancerAnswerLine@med.umich.edu
Start date:
August 12, 2022
Completion date:
August 2026
Lead sponsor:
Agency:
University of Michigan Rogel Cancer Center
Agency class:
Other
Source:
University of Michigan Rogel Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05578898
