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CLEAR Care Companion Application

CLEAR Care Companion Application

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05578898
Enrollment
28
Registered
2022-10-13
Start date
2022-08-12
Completion date
2024-07-24
Last updated
2025-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder Cancer, Radical Cystectomy

Keywords

Mobile application, Post surgical care

Brief 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.

Interventions

BEHAVIORALCLEAR Care Companion (CC) application

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.

Sponsors

University of Michigan Rogel Cancer Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Readmission intensity42 days post hospital dischargeTo measure the change in complexity of readmissions (readmission intensity), readmissions will be captured in the application and the EMR. For patients readmitted to Michigan Medicine, readmission parameters (reason for readmission, length of stay, interventions, ICU admission, etc.) will be captured and used to create a measure of readmission intensity. Descriptive statistics including (but not limited to) mean and standard deviation.
Patient Experience Survey -- Overall Care (first 20 participants)42 days post hospital dischargeThe first 20 participants will complete a qualtrix survey.
Frequency of engagement with application42 days post hospital dischargeTo measure patient engagement with the application, the number of responses to application notifications and patient inputs will be captured in the electronic medical record (EMR). Descriptive statistics will be used to assess frequency and duration of engagement.
Duration of engagement with application42 days post hospital dischargeTo measure patient engagement with the application, the number of responses to application notifications and patient inputs will be captured in the electronic medical record (EMR). Descriptive statistics will be used to assess frequency and duration of engagement.
Patient Experience Survey -- Overall Care (all participants)42 days post hospital dischargeAssessed using the Patient-Reported Outcomes Measurement Information System (PROMIS®) GLOBAL 10 questionnaire.

Secondary

MeasureTime frameDescription
Patient Experience Survey -- Application (first 20 participants)42 days post hospital dischargeThe first 20 participants will complete a qualtrix survey.
Readmission rate42 days post hospital dischargeReadmissions will be captured in the application and the EMR. Descriptive statistics including (but not limited to) mean and standard deviation.
Patient Experience Survey -- Application (all participants)42 days post hospital dischargeAssessed using the Patient-Reported Outcomes Measurement Information System (PROMIS®) GLOBAL 10 questionnaire.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026