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CLEAR Care Companion Application

Primary Purpose

Bladder Cancer, Radical Cystectomy

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CLEAR Care Companion (CC) application
Sponsored by
University of Michigan Rogel Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Bladder Cancer focused on measuring Mobile application, Post surgical care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Michigan Rogel Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CLEAR CC

Arm Description

Patients use CLEAR CC application with Smartphone or Tablet

Outcomes

Primary Outcome Measures

Frequency of engagement with application
To 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 application
To 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)
Assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS®) GLOBAL 10 questionnaire.
Patient Experience Survey -- Overall Care (first 20 participants)
The first 20 participants will complete a qualtrix survey.
Readmission intensity
To 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.

Secondary Outcome Measures

Patient Experience Survey -- Application (all participants)
Assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS®) GLOBAL 10 questionnaire.
Patient Experience Survey -- Application (first 20 participants)
The first 20 participants will complete a qualtrix survey.
Readmission rate
Readmissions will be captured in the application and the EMR. Descriptive statistics including (but not limited to) mean and standard deviation.

Full Information

First Posted
October 10, 2022
Last Updated
August 30, 2023
Sponsor
University of Michigan Rogel Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT05578898
Brief Title
CLEAR Care Companion Application
Official Title
CLEAR Care Companion Application
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
October 2026 (Anticipated)
Study Completion Date
October 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Michigan Rogel Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer, Radical Cystectomy
Keywords
Mobile application, Post surgical care

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CLEAR CC
Arm Type
Experimental
Arm Description
Patients use CLEAR CC application with Smartphone or Tablet
Intervention Type
Behavioral
Intervention Name(s)
CLEAR Care Companion (CC) application
Intervention 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.
Primary Outcome Measure Information:
Title
Frequency of engagement with application
Description
To 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.
Time Frame
42 days post hospital discharge
Title
Duration of engagement with application
Description
To 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.
Time Frame
42 days post hospital discharge
Title
Patient Experience Survey -- Overall Care (all participants)
Description
Assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS®) GLOBAL 10 questionnaire.
Time Frame
42 days post hospital discharge
Title
Patient Experience Survey -- Overall Care (first 20 participants)
Description
The first 20 participants will complete a qualtrix survey.
Time Frame
42 days post hospital discharge
Title
Readmission intensity
Description
To 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.
Time Frame
42 days post hospital discharge
Secondary Outcome Measure Information:
Title
Patient Experience Survey -- Application (all participants)
Description
Assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS®) GLOBAL 10 questionnaire.
Time Frame
42 days post hospital discharge
Title
Patient Experience Survey -- Application (first 20 participants)
Description
The first 20 participants will complete a qualtrix survey.
Time Frame
42 days post hospital discharge
Title
Readmission rate
Description
Readmissions will be captured in the application and the EMR. Descriptive statistics including (but not limited to) mean and standard deviation.
Time Frame
42 days post hospital discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffery Montgomery, M.D.
Organizational Affiliation
University of Michigan Rogel Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan Rogel Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cancer AnswerLine
Phone
800-865-1125
Email
CancerAnswerLine@med.umich.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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CLEAR Care Companion Application

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