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| ID | Type | Description | Link |
|---|---|---|---|
| U18HS028736 | U.S. AHRQ Grant/Contract | View source |
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| Name | Class |
|---|---|
| US Department of Veterans Affairs | FED |
| Agency for Healthcare Research and Quality (AHRQ) | FED |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mobile Health Application focused on behavioral treatments to treat urinary incontinence | Behavioral | Mobile health application for cell phones and computers that delivers evidence-based behavioral treatment for urinary incontinence, specifically tailored to women Veterans |
| Measure | Description | Time Frame |
|---|---|---|
| Urinary incontinence (UI) screening rates | 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 |
| Change, over time, in usage of the provider clinical data dashboard | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Enrollment rates of women Veterans for MyHealtheBladder | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Alayne D Markland, DO, MSc | UNIVERSITY OF ALABAMA AT BIRMINGHAM, BIRMINGHAM , AL | Principal Investigator |
| Lisa Zubkoff, PhD | University of Alabama at Birmingham, Birmingham, AL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham VA Healthcare System | Birmingham | Alabama | 35233 | United States | ||
| Atlanta VA Health Care System |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31774200 | Background | Goode PS, Markland AD, Echt KV, Slay L, Barnacastle S, Hale G, Wright MK, Lane TR, Burgio KL. A mobile telehealth program for behavioral treatment of urinary incontinence in women veterans: Development and pilot evaluation of MyHealtheBladder. Neurourol Urodyn. 2020 Jan;39(1):432-439. doi: 10.1002/nau.24226. Epub 2019 Nov 27. | |
| 40956581 | Background | Markland AD, Goldstein KM, Beasley TM, Boyd EM, Zubkoff L, Kelly UA, Burgio KL, Vaughan CP. Remote Access to Urinary Incontinence Treatments for Women Veterans: The PRACTICAL Randomized Clinical Trial. JAMA Netw Open. 2025 Sep 2;8(9):e2532111. doi: 10.1001/jamanetworkopen.2025.32111. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 7, 2024 |
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| Practice Facilitation | Combination Product | 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. |
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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 | 2-item questionnaire to explore adherence to completing PFMEs | 2-months post-Baseline |
| System Usability Scale | 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 | 3-item tool for feedback on participant satisfaction and perceived symptom improvement | 2-months post-Baseline |
| Decatur |
| Georgia |
| 30033 |
| United States |
| Jun 5, 2026 |
| Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 7, 2024 | Jun 5, 2026 | ICF_003.pdf |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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