A Pilot Study Evaluating the Usability of the Oabi Mobile Application

Overactive Bladder Clinical Trial

— OAB  

Official title:

A Pilot Study Evaluating the Usability of the Oabi Mobile Application

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04534946
• Other study ID #: 2016P002386
• Status: Completed
• Start date: March 20, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: August 2020
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: December 31, 2019
• Est. primary completion date: March 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive

Intervention

Other:
• This is not an intervention study
This is not an intervention study

Locations

Country	Name	City	State
United States	Mass General/North Shore Center	Salem	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Astellas Pharma Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mobile application usability	To assess the usability and acceptability of the mobile app via post-pilot survey	12 weeks
Secondary	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.	12 weeks