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Remote Access to Urinary Incontinence Treatment for Women Veterans (PRACTICAL)

Primary Purpose

Urinary Incontinence

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
VA Video Connect
MyHealtheBladder
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Incontinence focused on measuring women's health, Veterans, telemedicine, urinary incontinence, overactive urinary bladder, urinary bladder diseases, stress urinary incontinence, urge urinary incontinence, health education

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Women Veterans
  • Urinary incontinence occurring at least monthly for 3 months
  • Able to access daily internet via computer or mobile device
  • Access to personal email for MyHealtheBladder and VA Video Connect visit initiation and reminder

Exclusion Criteria:

  • Unstable medical conditions that could contribute to incontinence (e.g., recent major hospitalization, planned major surgery, conditions that affect urine volume - hemoglobin A1c of 9.0, chronic kidney disease with planned dialysis within 3 months, as assessed by PI or Site PI)
  • Unstable psychiatric conditions (e.g., psychosis, suicidal, active alcohol/substance abuse based on history and medical records)
  • Unstable housing situation
  • Genitourinary cancer undergoing active treatment with chemotherapy or radiation
  • Neurologic conditions known to contribute to incontinence (Multiple Sclerosis, Parkinson's Disease, TBI, Dementia, and Stroke Survivors with limited mobility)
  • New treatments for incontinence started in the prior 3 months or planned during the 6-month study duration, includes medications and/or surgery
  • Three months post-partum

Sites / Locations

  • Birmingham VA Medical Center, Birmingham, AL
  • Atlanta VA Medical and Rehab Center, Decatur, GA
  • Durham VA Medical Center, Durham, NC

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

MyHealthebladder

VA Video Connect

Arm Description

Daily mobile health education with information on bladder anatomy and function, pelvic floor muscle exercises with behavioral strategies, and self-monitoring tools for urine leakage

Remote telehealth visits with continence care provider who will provide education on bladder anatomy and function, pelvic floor muscle exercises with behavioral strategies, and self-monitoring tools for urine leakage

Outcomes

Primary Outcome Measures

Change in International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form (ICIQ-UI SF)
Urinary incontinence severity questionnaire, range 0-21, higher scores represent greater symptom severity

Secondary Outcome Measures

Change International Consultation on Incontinence Modular Questionnaire (ICIQ)-Overactive Bladder (OAB)
Overactive bladder symptom severity questionnaire, range 0-12, higher scores represent greater symptoms severity
Global Rating of Patient Satisfaction
Patient satisfaction question (PSQ) - 3 categories of response (highly satisfied, satisfied, not satisfied)
Self-reported Pelvic floor muscle exercise adherence
Adherence to pelvic floor muscle exercises reported as exercises per day completed over each week. Adherence defined as 80% of days with exercises completed over 12-week intervention period.
Change in International Consultation on Incontinence Modular Questionnaire (ICIQ)- Urinary Incontinence Short Form (ICIQ-UI SF)
Urinary incontinence severity questionnaire, range 0-21, higher scores represent greater symptom severity, longer term outcome

Full Information

First Posted
December 31, 2019
Last Updated
April 28, 2023
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT04237753
Brief Title
Remote Access to Urinary Incontinence Treatment for Women Veterans
Acronym
PRACTICAL
Official Title
Optimizing Remote Access to Urinary Incontinence Treatment for Women Veterans
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 6, 2020 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study is about assessing the helpfulness of two treatment delivery methods for bladder leakage or urinary incontinence. It is being funded by the Department of Veterans Affairs. By doing this study, the investigators hope to learn which treatment method is the most helpful remote delivery method for treating bladder leakage. The total participation time in this research is 6 months. During the first 8 -12 weeks of the study, you will receive standard of care from an online educational program (MyHealtheBladder) or a video visit with a provider through VA Video Connect. You will be selected by chance to receive MyHealtheBladder or VA Video Connect. About half-way through the study, the investigators will ask you about your bladder symptoms. If your bladder symptoms are not better, you will be selected by chance to continue the previous treatment or receive an initial or booster video session with a provider. Throughout the study, you will be asked to answer questions related to your health, bladder leakage, costs due to bladder leakage, and track your behavioral training.
Detailed 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence
Keywords
women's health, Veterans, telemedicine, urinary incontinence, overactive urinary bladder, urinary bladder diseases, stress urinary incontinence, urge urinary incontinence, health education

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Allocation
Randomized
Enrollment
286 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MyHealthebladder
Arm Type
Active Comparator
Arm Description
Daily mobile health education with information on bladder anatomy and function, pelvic floor muscle exercises with behavioral strategies, and self-monitoring tools for urine leakage
Arm Title
VA Video Connect
Arm Type
Active Comparator
Arm Description
Remote telehealth visits with continence care provider who will provide education on bladder anatomy and function, pelvic floor muscle exercises with behavioral strategies, and self-monitoring tools for urine leakage
Intervention Type
Behavioral
Intervention Name(s)
VA Video Connect
Other Intervention Name(s)
Telehealth visit with Continence Provider
Intervention Description
Remote telehealth visits with continence care provider who will provide education on bladder anatomy and function, pelvic floor muscle exercises with behavioral strategies, and self-monitoring tools for urine leakage
Intervention Type
Behavioral
Intervention Name(s)
MyHealtheBladder
Other Intervention Name(s)
Mobile health bladder education
Intervention Description
Daily mobile health education with information on bladder anatomy and function, pelvic floor muscle exercises with behavioral strategies, and self-monitoring tools for urine leakage
Primary Outcome Measure Information:
Title
Change in International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form (ICIQ-UI SF)
Description
Urinary incontinence severity questionnaire, range 0-21, higher scores represent greater symptom severity
Time Frame
baseline to 12 weeks
Secondary Outcome Measure Information:
Title
Change International Consultation on Incontinence Modular Questionnaire (ICIQ)-Overactive Bladder (OAB)
Description
Overactive bladder symptom severity questionnaire, range 0-12, higher scores represent greater symptoms severity
Time Frame
baseline to 12-weeks
Title
Global Rating of Patient Satisfaction
Description
Patient satisfaction question (PSQ) - 3 categories of response (highly satisfied, satisfied, not satisfied)
Time Frame
12-weeks
Title
Self-reported Pelvic floor muscle exercise adherence
Description
Adherence to pelvic floor muscle exercises reported as exercises per day completed over each week. Adherence defined as 80% of days with exercises completed over 12-week intervention period.
Time Frame
12-weeks
Title
Change in International Consultation on Incontinence Modular Questionnaire (ICIQ)- Urinary Incontinence Short Form (ICIQ-UI SF)
Description
Urinary incontinence severity questionnaire, range 0-21, higher scores represent greater symptom severity, longer term outcome
Time Frame
baseline to 24-weeks
Other Pre-specified Outcome Measures:
Title
Change in Incontinence Resource Utilization Questionnaire: IRUQ
Description
Direct and indirect costs for treatments for pads, clothing, toiletries, and laundry costs. Measure will be reported as mean costs.
Time Frame
baseline and 12-weeks
Title
Miles saved
Description
Mean miles saved from home location to specialty care clinic location over 12-week intervention
Time Frame
12-weeks
Title
Health Information Technology Usability Evaluation Scale (Health-ITUES)
Description
Mean score on the Health-ITUES will be compared per intervention arm: score ranging from 20-100 with higher scores representing higher agreement with usefulness
Time Frame
12-weeks
Title
Change in Adaptive Behavior Index scores
Description
Adaptive behaviors index scores for urinary incontinence symptoms for two subscales: Hygiene and Avoidance domains. Scores range from 0-100; higher domain scores indicated greater use of adaptive behaviors
Time Frame
baseline to 12-weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Women Veterans Urinary incontinence occurring at least monthly for 3 months Able to access daily internet via computer or mobile device Access to personal email for MyHealtheBladder and VA Video Connect visit initiation and reminder Exclusion Criteria: Unstable medical conditions that could contribute to incontinence (e.g., recent major hospitalization, planned major surgery, conditions that affect urine volume - hemoglobin A1c of 9.0, chronic kidney disease with planned dialysis within 3 months, as assessed by PI or Site PI) Unstable psychiatric conditions (e.g., psychosis, suicidal, active alcohol/substance abuse based on history and medical records) Unstable housing situation Genitourinary cancer undergoing active treatment with chemotherapy or radiation Neurologic conditions known to contribute to incontinence (Multiple Sclerosis, Parkinson's Disease, TBI, Dementia, and Stroke Survivors with limited mobility) New treatments for incontinence started in the prior 3 months or planned during the 6-month study duration, includes medications and/or surgery Three months post-partum
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alayne D Markland, DO MSc
Organizational Affiliation
Birmingham VA Medical Center, Birmingham, AL
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Elizabeth Camille Vaughan, MD MS
Organizational Affiliation
Atlanta VA Medical and Rehab Center, Decatur, GA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Susan N. Hastings, MD MHSc
Organizational Affiliation
Durham VA Medical Center, Durham, NC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Birmingham VA Medical Center, Birmingham, AL
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233-1927
Country
United States
Facility Name
Atlanta VA Medical and Rehab Center, Decatur, GA
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Durham VA Medical Center, Durham, NC
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
For purposes of this study, all data will be stripped of all patient identifiers and each participant will be given a unique identifier for the study. Participant records will be stored in a locked cabinet in a locked office and will be accessible only to the Principal Investigator, Nurse Practitioner delivering the intervention, Research Coordinator, and Site PI's (Markland, Vaughan, and Goldstein) and co-investigators per site-PI's guidance. Computer-based records will be maintained through the Veteran's Administration Computerized Patient Record System (CPRS), a secure network with password protection. A separate tracking database with participant identifiers that provide a link to the unique study IDs will be stored on a secure VA research server at each study site. Only deidentified data will be entered into the Redcap database by study personnel who are credentialed at the Birmingham VAMC through the research office.
IPD Sharing Time Frame
Data will become available 1-year following the reporting of the primary and secondary outcome analyses.
IPD Sharing Access Criteria
By study team permission

Learn more about this trial

Remote Access to Urinary Incontinence Treatment for Women Veterans

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