Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Urinary Incontinence
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Randomized clinical trial with adaptive trial design. Randomization will first involve treatment with one of two delivery methods: (1) a web-based mobile health application or (2) a single video session. For women who do not improve (SMART design), they will receive a first or second video session.Masking: Single (Outcomes Assessor)Primary Purpose: Treatment

Participation Requirements

Age
Younger than 125 years
Gender
Only males

Description

This study represents a unique opportunity to improve access to treatments for urine leakage for women Veterans. This research study will examine the effects of two mobile health technologies on improving bladder symptoms, as part of a randomized clinical trial. The study includes 260 women Veterans...

This study represents a unique opportunity to improve access to treatments for urine leakage for women Veterans. This research study will examine the effects of two mobile health technologies on improving bladder symptoms, as part of a randomized clinical trial. The study includes 260 women Veterans recruited from 3 sites: the Birmingham VAMC, the Atlanta VAHCS, and the Durham VAMC (86 per site). Women will receive first-line treatments for urine leakage through randomization to one of two delivery methods for direct treatment: (1) a web-based mobile health application that delivers content daily for 8 weeks compared to (2) a single video session delivered by VA Video Connect. At 8-weeks, women who do not have improved symptoms will have the ability to continue the treatment or receive an initial or booster video session. The investigators will measure bladder symptoms (3 questions by self-report over the phone or via survey) at baseline, 8-weeks, 12-weeks, and 6-months. Additionally, the investigators will interview 54 women Veterans and 12 providers to learn about their experiences with the technologies using 1:1 telephone interviews at 12-weeks. The findings from this study will inform the best technology to improve access for bladder leakage among women Veterans across a wider array of VHA facilities.

Tracking Information

NCT #
NCT04237753
Collaborators
Not Provided
Investigators
Principal Investigator: Alayne D Markland, DO MSc Birmingham VA Medical Center, Birmingham, AL Principal Investigator: Elizabeth Camille Vaughan, MD MS Atlanta VA Medical and Rehab Center, Decatur, GA Principal Investigator: Susan N. Hastings, MD MHSc Durham VA Medical Center, Durham, NC