Continence Across Continents to Upend Stigma and Dependency

Study Overview
=================
Brief Summary
-----------------
To determine whether women exposed to the continence promotion intervention will report improved urinary symptoms and quality of life, and lower incontinence-related stigma and falls than women who receive a control intervention at one-year post-intervention.

Detailed Description
-----------------
This is a cluster-randomized 4-site intervention study testing the effect of a continence-promotion intervention on: Improved urinary symptoms and quality of life Reduction in falls Reduction in stigma A cost-effectiveness component will also be included

Official Title
-----------------
Phase 3 Cluster Randomised Trial Testing the Efficacy of a Continence Promotion Intervention to Improve Urinary Symptoms and Quality of Life, and Reduce Stigma and Falls in Older Community-dwelling Women With Untreated Incontinence

Conditions
-----------------
Urinary Incontinence, Falls, Accidental, Quality of Life, Stigma

Intervention / Treatment
-----------------
* Behavioral: Continence promotion group education workshop
* Behavioral: Sham health lecture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women 65 years and older Urinary incontinence at least once weekly Exclusion Criteria: Living in residential or long-term care Received treatment for incontinence within the past year Dementia or other neurological conditions that preclude the ability to provide -Informed consent

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Continence promotion group education<br>A single 1-hour continence promotion group education workshop, facilitated by the research coordinator, aimed at changing knowledge and beliefs about urinary incontinence and different treatment options. An evidence-based self-management tool will be distributed at the end of the workshop. | Behavioral: Continence promotion group education workshop<br>* Interactive group education workshop promoting continence<br>|
| Sham Comparator: Sham health lecture<br>A single 1-hour group education workshop on other health topics of concern to older women such as memory, hearing, insomnia | Behavioral: Sham health lecture<br>* Interactive group education workshop about general health<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported improvement in urinary incontinence | Patient global impression of improvement questionnaire Sandvik severity index ICIQ-FLUTS | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Falls | Reduction in incontinence-related falls measured by fall diary | 1 year | 
| Reduction in incontinence related stigma and quality of life | Measured with the Incontinence Quality of Life questionnaire (IQOL) | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Urinary incontinence, Falls, Quality of life, Stigma, Community-dwelling older women, Continence promotion