Improving Primary Care Access to Urinary Incontinence Treatment for Women Veterans (PURSUIT)

February 5, 2024 updated by: Alayne D. Markland, University of Alabama at Birmingham

Improving Primary Care Understanding of Resources and Screening for Urinary Incontinence to Enhance Treatment

The PURSUIT project aims to improve access to evidence-based nonsurgical UI treatment for women Veterans in the Southeast region of the United States using the most effective remote delivery modality. Using cluster randomization, the study will compare two models at the practice level: (1) the use of a practice facilitation toolkit with a mHealth UI modality alone and (2) the practice facilitation toolkit with a mHealth UI model combined with education on clinical pathways for consultation. Patient level outcomes related to UI symptom improvement will be compared. Patient and provider perceptions of factors that could influence future remote UI treatment scalability will also be assessed. All primary care practices will receive practice facilitation with a PURSUIT toolkit that includes (1) 1-2 visits with a practice facilitator; (2) mobile-health or mHealth application training (MAT); 3) online resource hub; and (4) health information technology (HIT) assistance. PURSUIT's future goal is to disseminate the most effective modality for delivering nonsurgical UI treatment for women Veterans nationally within the VHA.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

PURSUIT aims to recruit 62 practices to participate in the trial implementation at 50 practices. Specifically, Community-Based Outpatient Clinics (CBOCs) from VA Integrated Service Network (VISN) 7 will be targeted, spanning the states of Alabama, Georgia, and South Carolina. The project will focus on VISN 7 CBOCs, serving at least 50 women Veterans with primary care services, will be recruited through connections with local women's health providers. The team estimates outreach to approximately 50,000 women Veterans and estimates that 30 percent (n=15,000) of these women will have UI symptoms, and, among those, 15 percent (n=2,500) will participate.

Study Type

Observational

Enrollment (Estimated)

2500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The team estimates outreach to approximately 50,000 women Veterans and estimates that 30 percent (n=15,000) of these women will have UI symptoms, and, among those, 15 percent (n=2,500) will participate.

Description

Inclusion Criteria:

  • Veteran
  • English-speaking, community-dwelling women Veterans
  • Diagnosis of UI (all types)
  • Access to the internet via a mobile device or computer

Exclusion Criteria:

  • Women Veterans who are currently pregnant or less than 12 weeks postpartum

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Women Veterans receiving primary care in VISN-7 of the VA Healthcare Administration (VHA)
This project will include English-speaking, community-dwelling women Veterans 20 years or older with a diagnosis of UI (all types) and access to the internet via a mobile device or computer. Women Veterans who are currently pregnant or less than 12 weeks postpartum will be excluded. PURSUIT utilizes a mobile health application, called MyHealtheBladder, to connect patients with nonsurgical treatment options.
Behavioral: Mobile Health Application focused on behavioral treatments to treat urinary incontinence
Mobile health application for cell phones and computers that delivers evidence-based behavioral treatment for urinary incontinence, specifically tailored to women Veterans
Other Names:
  • MyHealtheBladder
Health care providers in community-based outpatient clinics in VISN-7 of the the VHA
Community-Based Outpatient Clinics (CBOCs) from VA Integrated Service Network (VISN) 7 will be targeted, spanning the states of Alabama, Georgia, and South Carolina. VISN 7 CBOCs, serving at least 50 women Veterans with primary care services, will be recruited.
Combination product: Practice Facilitation
The toolkit has 4 components: (1) Practice Facilitation Visits, (2) Mobile-health or mHealth Application Training (MAT) training, (3) Access and education on the Data Dashboard, and (4) Health information technology (HIT) assistance.
Other Names:
  • Practice facilitation toolkit

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change, over time, in usage of the provider clinical data dashboard
Time Frame: Baseline and 6 months post-Baseline
This will include capturing the unique number of clinic site "champions" (i.e. designated women's health provider) who engage with this program's clinical data dashboard. Dashboard engagement will be measured as the number of unique site champions who use the dashboard divided by the total number of site champions involved in this program.
Baseline and 6 months post-Baseline
Urinary incontinence (UI) screening rates
Time Frame: Baseline and 6 months post-Baseline
This will include measuring changes, over time, in UI diagnoses for women Veterans. These changes will be measured by pulling data on UI ICD-9 and ICD-10 codes collected via the program's clinical data dashboard.
Baseline and 6 months post-Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Enrollment rates of women Veterans for MyHealtheBladder
Time Frame: 2-, 4-, and 6-months post-Baseline
Women receiving behavioral urinary incontinence treatment on MyHealtheBladder
2-, 4-, and 6-months post-Baseline
International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF)
Time Frame: Baseline and 2-months post-Baseline
4-item tool to measure UI symptoms, scored on scale from 0-21 with a higher score indicating worse symptoms
Baseline and 2-months post-Baseline
Pelvic Floor Muscle Exercise (PFME) Adherence
Time Frame: 2-months post-Baseline
2-item questionnaire to explore adherence to completing PFMEs
2-months post-Baseline
System Usability Scale
Time Frame: 2-months post-Baseline
10-item questionnaire, using 5-point Likert scale, to gauge the usability of MHB. Scoring range is 0-100 with a higher score indicating the system is more usable,
2-months post-Baseline
Satisfaction and Perception of Improvement
Time Frame: 2-months post-Baseline
3-item tool for feedback on participant satisfaction and perceived symptom improvement
2-months post-Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Collaborators

US Department of Veterans Affairs
Agency for Healthcare Research and Quality (AHRQ)

Investigators

  • Principal Investigator: Alayne D Markland, UNIVERSITY OF ALABAMA AT BIRMINGHAM, BIRMINGHAM , AL

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2022

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

May 25, 2022

First Submitted That Met QC Criteria

June 27, 2022

First Posted (Actual)

June 30, 2022

Study Record Updates

Last Update Posted (Estimated)

February 7, 2024

Last Update Submitted That Met QC Criteria

February 5, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1658917-2
  • U18HS028736 (U.S. AHRQ Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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