Community-Based Continence Promotion: Sustaining Healthy Aging in Place (SHAIP) Through Mind Over Matter (MOM)

Study Overview
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Brief Summary
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The goal of this study is to obtain data about the effectiveness, reach, adoption, and implementation potential of an innovative, combined urinary/bowel continence workshop through a randomized controlled trial in six Wisconsin communities. This three-session workshop is based on proven principles of behavior change addressing urinary and bowel continence self-management and health education and has been developed specifically for administration to women age 50 and older in senior centers. We hypothesize that workshop participants will experience improvements in urinary and bowel incontinence symptoms, will have increased levels of care-seeking and self-efficacy for these conditions, and will maintain the self-management strategies taught in the workshop 3 months following completion of the workshop. We further hypothesize that this workshop will reach its intended target population (independent senior women with incontinence) and will improve their mental health by destigmatizing the condition of incontinence.

Official Title
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Community-Based Continence Promotion: Sustaining Healthy Aging in Place (SHAIP) Through Mind Over Matter (MOM)

Conditions
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Fecal Incontinence in Old Age, Urinary Incontinence in Old Age

Intervention / Treatment
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* Behavioral: Mind Over Matter; Healthy Bowels, Healthy Bladder


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: qualifying symptoms within last 3 months able to speak English lives independently Exclusion Criteria: new treatment for target symptoms within last 3 months

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment<br>Completes the Mind Over Matter; Healthy Bowels, Healthy Bladder workshop in the spring 2017. | Behavioral: Mind Over Matter; Healthy Bowels, Healthy Bladder<br>* This three-session workshop is based on proven principles of behavior change addressing urinary and bowel continence self-management and health education and has been developed specifically for administration to women age 50 and older in senior centers.<br>|
| Other: Control<br>Completes the Mind Over Matter; Healthy Bowels, Healthy Bladder workshop in the fall 2017. | Behavioral: Mind Over Matter; Healthy Bowels, Healthy Bladder<br>* This three-session workshop is based on proven principles of behavior change addressing urinary and bowel continence self-management and health education and has been developed specifically for administration to women age 50 and older in senior centers.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom Improvement | Patient Global Impression of Improvement (PGI-I) regarding bladder or bowel incontinence | 3 months after treatment group completes intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pelvic Floor Distress Inventory-20 | validated instrument | 3 months after treatment group completes intervention | 
| Geriatric Self-Efficacy for Urinary Incontinence (GSE-UI) | validated instrument | 3 months after treatment group completes intervention | 
| Barriers to Care-seeking for Accidental Bowel Leakage (BCABL) | validated instrument | 3 months after treatment group completes intervention | 
| Barriers to Incontinence Care-seeking (BICS-Q) | validated instrument | 3 months after treatment group completes intervention |