Clinical trial NCT03140852: Community-Based Continence Promotion: Sustaining Healthy Aging in Place (SHAIP) Through Mind Over Matter (MOM)
Official title: Community-Based Continence Promotion: Sustaining Healthy Aging in Place (SHAIP) Through Mind Over Matter (MOM)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fecal Incontinence in Old Age
Urinary Incontinence in Old Age
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: Wisconsin Partnership Program
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2017-05-04
Enrollment: 122
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Symptom Improvement
timeFrame: 3 months after treatment group completes intervention
Secondary outcomes:
measure: Pelvic Floor Distress Inventory-20
timeFrame: 3 months after treatment group completes intervention
measure: Geriatric Self-Efficacy for Urinary Incontinence (GSE-UI)
timeFrame: 3 months after treatment group completes intervention
measure: Barriers to Care-seeking for Accidental Bowel Leakage (BCABL)
timeFrame: 3 months after treatment group completes intervention
measure: Barriers to Incontinence Care-seeking (BICS-Q)
timeFrame: 3 months after treatment group completes intervention
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin-Madison School of Medicine and Public Health
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Heidi Brown, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brown HW, Braun EJ, Wise ME, Myers S, Li Z, Sampene E, Jansen SM, Moberg DP, Mahoney JE, Rogers RG. Small-Group, Community-Member Intervention for Urinary and Bowel Incontinence: A Randomized Controlled Trial. Obstet Gynecol. 2019 Sep;134(3):600-610. doi: 10.1097/AOG.0000000000003422.