Clinical trial NCT04534946: A Pilot Study Evaluating the Usability of the Oabi Mobile Application
Official title: A Pilot Study Evaluating the Usability of the Oabi Mobile Application
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Overactive Bladder
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Astellas Pharma Inc
First posted: 2020-09-01
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with a primary diagnosis of overactive bladder disorder

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.

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).

Primary outcomes:
measure: Mobile application usability
timeFrame: 12 weeks
Secondary outcomes:
measure: User application engagement
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Salem
country: United States
facility: Mass General/North Shore Center
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Kamal Jethwani, MD
role: PRINCIPAL_INVESTIGATOR
References: