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

Urinary Incontinence in Old Age Clinical Trial

— SHAIP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03140852
• Other study ID #: 2017-0133
• Secondary ID: A532840SMPH\OBST
• Status: Completed
• Phase: N/A
• Start date: April 25, 2017
• Est. completion date: November 1, 2017

Study information

• Verified date: December 2019
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: November 1, 2017
• Est. primary completion date: November 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fecal Incontinence
• Fecal Incontinence in Old Age
• Urinary Incontinence
• Urinary Incontinence in Old Age

Intervention

Behavioral:
• Mind Over Matter; Healthy Bowels, Healthy Bladder
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.

Locations

Country	Name	City	State
United States	University of Wisconsin-Madison School of Medicine and Public Health	Madison	Wisconsin

Sponsors (3)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Wisconsin Partnership Program

Country where clinical trial is conducted

United States, 

References & Publications (1)

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: — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptom Improvement	Patient Global Impression of Improvement (PGI-I) regarding bladder or bowel incontinence	3 months after treatment group completes intervention
Secondary	Pelvic Floor Distress Inventory-20	validated instrument	3 months after treatment group completes intervention
Secondary	Geriatric Self-Efficacy for Urinary Incontinence (GSE-UI)	validated instrument	3 months after treatment group completes intervention
Secondary	Barriers to Care-seeking for Accidental Bowel Leakage (BCABL)	validated instrument	3 months after treatment group completes intervention
Secondary	Barriers to Incontinence Care-seeking (BICS-Q)	validated instrument	3 months after treatment group completes intervention