NCT06384066

Brief Summary

Create a custom urethroplasty mobile application that will guide patients through through the surgical process.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2023

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 28, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 19, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 25, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 11, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 11, 2024

Completed
Last Updated

November 26, 2024

Status Verified

November 1, 2024

Enrollment Period

12 months

First QC Date

February 19, 2024

Last Update Submit

November 22, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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.

    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

    0 to 12 months

  • Rate of emergency department visits

    Assess through chart review and patient reporting events.

    0 to 12 months

Study Arms (2)

Standard of Care

OTHER

Standard Care

Other: Standard of Care

Standard Care + GetWell App

OTHER
Other: GetWell Mobile ApplicationOther: Standard of Care

Interventions

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 Care + GetWell App

Office Based Pathway

Standard Care + GetWell AppStandard of Care

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or older
  • Have a Urethral stricture and are under going urethroplasty surgery

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Urethral Stricture

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Urethral ObstructionUrethral DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 19, 2024

First Posted

April 25, 2024

Study Start

September 28, 2023

Primary Completion

September 11, 2024

Study Completion

September 11, 2024

Last Updated

November 26, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations