A Pilot Study Evaluating the Usability of the Oabi Mobile... | NCT04534946

Studies
A Pilot Study Evaluating the Usability of the Oabi Mobile Application

NCT04534946

Sponsor

Massachusetts General Hospital

Status

Completed

Last Update Posted

Sep 1, 2020Actual

Enrollment

35Actual

Phase

Not provided

Conditions

Overactive Bladder

Interventions

This is not an intervention study

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 20, 2017Actual

Primary Completion Date

Mar 31, 2019Actual

Completion Date

Dec 31, 2019Actual

First Submitted Date

Mar 26, 2018

First Submission Date that Met QC Criteria

Aug 31, 2020

First Posted Date

Sep 1, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 31, 2020

Last Update Posted Date

Sep 1, 2020Actual

Name	Class
Astellas Pharma Inc	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Our primary purpose is to assess the use feasibility and acceptability of the study phone app called, "Oabi" app with patients diagnosed with overactive bladder disorder (OAB).

Detailed Description

Tracking overactive bladder disorder can be an important part of managing the disease. It can help the patient and the health care providers keep a tab on what is working to help manage OAB symptoms. Tracking urination patterns can actually help patients normalize their bladder problems. By focusing on certain behaviors and habits that contribute to their OAB and changing those behaviors, patients can effectively control OAB symptoms. The Oabi mobile application has been created with the goal of helping patients learn more about their day-to-day symptoms as well as track and self-manage their symptoms. Additionally, the Oabi app connects patients with their HCP via a clinician portal to boost communication, and encourage patient-provider interaction. The goal of this pilot study is to evaluate the usability and acceptability of the Oabi mobile app.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

35Actual

Name	Type	Description	Arm Group Labels	Other Names
This is not an intervention study	Other	This is not an intervention study

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mobile application usability	To assess the usability and acceptability of the mobile app via post-pilot survey	12 weeks

Secondary Outcomes

Measure	Description	Time Frame
User application engagement	To assess participant engagement with the Oabi app, to assess provider engagement and satisfaction with the Oabi clinician portal, to assess the perceived value of the app in how it impacts the HCP-patient dialogue and patient care related to the management of OAB (qualitatively), and to gather recommendations for modifications to the Oabi app and clinician portal from users.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with a primary diagnosis of OAB (with active OAB symptoms) with or without urge incontinence who are:
- Treatment-naive patients who started a new treatment within two weeks prior to the study enrollment
- Transitioning to another treatment (pharmacotherapy)
- Transitioning from behavioral therapy to pharmacotherapy
Adults aged 18 yrs and above.
Own a Smartphone with Android Operating System with an OS of 5.0 or higher or willing to use a study phone as their primary for the duration of the study (Samsung Galaxy S6).
Sufficient understanding of the English language to be able to read and understand study procedures.
Willing to participate in the research study and sign informed consent.
Has adequate access to the internet to use the app.

Exclusion Criteria:

Subjects unable or unwilling to participate for at least three months.
Subjects with vision, hearing, and/or speech problems that may limit their participation in data collection procedures.
Subjects with physical limitations that limit may their ability to use a Smartphone, effectively navigate a Smartphone app, and type on a Smartphone.
Participants with the history of urological surgery or those currently using a urinary sling.
Participants on botox treatment for OAB.
Participants with OAB symptoms due to coexisting conditions such as urinary tract infection (UTI), and or benign prostatic hypertrophy (BPH).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adult patients with a primary diagnosis of overactive bladder disorder

Sampling Method

Non-Probability Sample

ID	Term
D001745	Urinary Bladder Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications