Urethral StrictureNCT06384066
Mobile Health Application to Improve Patient Satisfaction After Urethroplasty
A study testing GetWell Mobile Application in people with Urethral Stricture, run by Northwestern University at 1 site in United States.
Trial summary
Create a custom urethroplasty mobile application that will guide patients through through the surgical process. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Urethral Stricture
- What is being tested?
- GetWell Mobile Application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Sep 2023to 11 Sep 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 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Have a Urethral stricture and are under going urethroplasty surgery
Who cannot join
- Patients that do not have mobile phone capabilities
- Patients who have physical or cognitive impairment when using a mobile phone or answering questionnaires
- Inability to provide consent to the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of a Mobile Health Application to Improve Patient Satisfaction and Outcomes After Urethroplasty: a Prospective Randomized Controlled Trial
Create a custom urethroplasty mobile application that will guide patients through through the surgical process.
- Conditions
- Urethral Stricture
- Being tested
- GetWell Mobile Application, Standard of Care
- Medical subject headings
- Urethral Stricture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GetWell Mobile ApplicationOther
GetWell utilizes an interactive health care application to allow patients to participate in their care. We plan to work with GetWell to develop a custom built plan for urethroplasty patients and provide patient education.
Standard of CareOther
Office Based Pathway
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Other | Standard Care Receives: Other: Standard of Care |
| Standard Care + GetWell App | Other | Not described Receives: Other: GetWell Mobile Application; Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improve patient satisfaction, education and reported outcomes
Asses through Patient reported outcome measurement survey, Urethral Stricture Symptom and Impact Measurement and Patient-Reported Outcomes Measurement information System 29-item profile (PROMIS) which assesses pain intensity using a 0-10 rating item, with higher scores being a worse outcome.
Measured: 0 to 3 months
Change in rate of patient phone calls and messages
assess through chart review to evaluate the number of chart messages and phone calls
Measured: 0 to 12 months
Rate of emergency department visits
Assess through chart review and patient reporting events.
Measured: 0 to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2024
- Study start28 Sep 2023 (estimated)
- Primary completion11 Sep 2024
- Study completion11 Sep 2024
Why it stopped: The study team will not pursue this study moving forward. There have been no patients enrolled and the project will not continue. Study has been terminated with the IRB.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urethral StrictureStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ziho Lee, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06384066
- Sponsor's protocol ID
- STU00219774
- Status last verified
- Nov 2024
- First submitted
- 19 Feb 2024
- Last updated
- 26 Nov 2024
- Results posted
- No
- Data monitoring committee
- 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 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Mobile Health Application to Improve Patient Satisfaction and Outcomes After Urethroplasty: a Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06384066
- Acronym / sponsor ID
- STU00219774
- Conditions
- Urethral Stricture
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study team will not pursue this study moving forward. There have been no patients enrolled and the project will not continue. Study has been terminated with the IRB.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 28 Sep 2023 (estimated)
- Primary completion
- 11 Sep 2024 (actual)
- Study completion
- 11 Sep 2024 (actual)
- First posted
- 25 Apr 2024 (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.
Create a custom urethroplasty mobile application that will guide patients through through the surgical process.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Other | Other: Standard of CareStandard Care |
| Standard Care + GetWell App | Other | Other: GetWell Mobile Application, Other: Standard of Care |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years of age or older
- Have a Urethral stricture and are under going urethroplasty surgery
Key exclusion criteria (3 listed)
- Patients that do not have mobile phone capabilities
- Patients who have physical or cognitive impairment when using a mobile phone or answering questionnaires
- Inability to provide consent to the study
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 |
|---|---|---|
| GetWell Mobile ApplicationGetWell utilizes an interactive health care application to allow patients to participate in their care. We plan to work with GetWell to develop a custom built plan for urethroplasty patients and provide patient education. | Other | Standard Care + GetWell App |
| Standard of CareOffice Based Pathway | Other | Standard Care + GetWell App, Standard of Care |
Primary outcome
Improve patient satisfaction, education and reported outcomes
Time frame: 0 to 3 months
Asses through Patient reported outcome measurement survey, Urethral Stricture Symptom and Impact Measurement and Patient-Reported Outcomes Measurement information System 29-item profile (PROMIS) which assesses pain intensity using a 0-10 rating item, with higher scores being a worse outcome.
Change in rate of patient phone calls and messages
Time frame: 0 to 12 months
assess through chart review to evaluate the number of chart messages and phone calls
Rate of emergency department visits
Time frame: 0 to 12 months
Assess through chart review and patient reporting events.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GetWell Mobile Application in people with Urethral Stricture, run by Northwestern University 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 2 inclusion and 3 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: withdrawn, as of the sponsor's last update on 26 Nov 2024. 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 was withdrawn before enrolling participants, so there are no results.
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?
Improve patient satisfaction, education and reported outcomes (time frame: 0 to 3 months). The study lists 3 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 26 Nov 2024.