Bladder CancerNCT05578898
CLEAR Care Companion Application
A study testing CLEAR Care Companion (CC) application in people with Bladder Cancer and Radical Cystectomy, run by University of Michigan Rogel Cancer Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer, Radical Cystectomy
- What is being tested?
- CLEAR Care Companion (CC) application
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Aug 2022to 24 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Non-English speaking patients
- Patients without access to a smart phone or tablet with internet capacity
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, 48109
About this study
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.
Read the 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.
- Conditions
- Bladder Cancer, Radical Cystectomy
- Being tested
- CLEAR Care Companion (CC) application
- Keywords
- Mobile application, Post surgical care
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CLEAR Care Companion (CC) applicationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| CLEAR CC | Experimental | Patients use CLEAR CC application with Smartphone or Tablet Receives: Behavioral: CLEAR Care Companion (CC) application |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 42 days post hospital discharge
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.
Measured: 42 days post hospital discharge
Patient Experience Survey -- Overall Care (all participants)
Assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS®) GLOBAL 10 questionnaire.
Measured: 42 days post hospital discharge
Patient Experience Survey -- Overall Care (first 20 participants)
The first 20 participants will complete a qualtrix survey.
Measured: 42 days post hospital discharge
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.
Measured: 42 days post hospital discharge
Secondary outcomes (3)
Patient Experience Survey -- Application (all participants)
Assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS®) GLOBAL 10 questionnaire.
Measured: 42 days post hospital discharge
Patient Experience Survey -- Application (first 20 participants)
The first 20 participants will complete a qualtrix survey.
Measured: 42 days post hospital discharge
Readmission rate
Readmissions will be captured in the application and the EMR. Descriptive statistics including (but not limited to) mean and standard deviation.
Measured: 42 days post hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2022
- Study start12 Aug 2022
- Primary completion24 Jul 2024
- Study completion24 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeffery Montgomery, M.D., Principal investigator, University of Michigan Rogel Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05578898
- Sponsor's protocol ID
- UMCC 2021.077
- Other IDs
- HUM00201652
- Status last verified
- Jan 2025
- First submitted
- 10 Oct 2022
- Last updated
- 8 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CLEAR Care Companion Application
- ClinicalTrials.gov ID
- NCT05578898
- Acronym / sponsor ID
- UMCC 2021.077
- Conditions
- Bladder Cancer, Radical Cystectomy
- Keywords
- Mobile application, Post surgical care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of Michigan Rogel Cancer CenterUniversity, hospital or other
- Study start
- 12 Aug 2022 (actual)
- Primary completion
- 24 Jul 2024 (actual)
- Study completion
- 24 Jul 2024 (actual)
- First posted
- 13 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CLEAR CC | Experimental | Behavioral: CLEAR Care Companion (CC) applicationPatients use CLEAR CC application with Smartphone or Tablet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Non-English speaking patients
- Patients without access to a smart phone or tablet with internet capacity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CLEAR Care Companion (CC) applicationThe 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. | Behavioural | CLEAR CC |
Primary outcome
Frequency of engagement with application
Time frame: 42 days post hospital discharge
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
Time frame: 42 days post hospital discharge
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)
Time frame: 42 days post hospital discharge
Assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS®) GLOBAL 10 questionnaire.
Patient Experience Survey -- Overall Care (first 20 participants)
Time frame: 42 days post hospital discharge
The first 20 participants will complete a qualtrix survey.
Readmission intensity
Time frame: 42 days post hospital discharge
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.
3 secondary outcomes
Patient Experience Survey -- Application (all participants)
Time frame: 42 days post hospital discharge
Patient Experience Survey -- Application (first 20 participants)
Time frame: 42 days post hospital discharge
Readmission rate
Time frame: 42 days post hospital discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffery Montgomery, M.D. principal investigator
University of Michigan Rogel Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CLEAR Care Companion (CC) application in people with Bladder Cancer and Radical Cystectomy, run by University of Michigan Rogel Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of engagement with application (time frame: 42 days post hospital discharge). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2025.