A Pilot Study Evaluating the Usability of the Oabi Mobile Application (OAB)

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).

Study Overview

• Status: Completed
• Conditions: Overactive Bladder
• Intervention / Treatment: Other: This is not an intervention study

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.

• Study Type: Observational
• Enrollment (Actual): 35

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Salem, Massachusetts, United States, 01970
      • Mass General/North Shore Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients with a primary diagnosis of overactive bladder disorder

Description

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).

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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.	12 weeks

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: Astellas Pharma Inc
• Investigators: Principal Investigator: Kamal Jethwani, MD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2017
• Primary Completion (Actual): March 31, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: March 26, 2018
• First Submitted That Met QC Criteria: August 31, 2020
• First Posted (Actual): September 1, 2020

Study Record Updates

• Last Update Posted (Actual): September 1, 2020
• Last Update Submitted That Met QC Criteria: August 31, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Bladder, Overactive
• Other Study ID Numbers: 2016P002386

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will not be shared with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No