A Pilot Study Evaluating the Usability of the Oabi Mobile Application

NCT ID: NCT04534946

Last Updated: 2020-09-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 35 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-03-20
• Study Completion Date: 2019-12-31

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.

Conditions

Overactive Bladder

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

This is not an intervention study

This is not an intervention study

Intervention Type: OTHER

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Astellas Pharma Inc

INDUSTRY

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Joseph C. Kvedar

Dermatologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kamal Jethwani, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Mass General/North Shore Center

Salem, Massachusetts, United States

Countries

United States

Other Identifiers

2016P002386

Identifier Type: -

Identifier Source: org_study_id