Community-Based Continence Promotion: Sustaining Healthy Aging in Place (SHAIP) Through Mind Over Matter (MOM) (SHAIP)
Primary Purpose
Fecal Incontinence in Old Age, Urinary Incontinence in Old Age
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mind Over Matter; Healthy Bowels, Healthy Bladder
Sponsored by
About this trial
This is an interventional treatment trial for Fecal Incontinence in Old Age
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
Sites / Locations
- University of Wisconsin-Madison School of Medicine and Public Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Other
Arm Label
Treatment
Control
Arm Description
Completes the Mind Over Matter; Healthy Bowels, Healthy Bladder workshop in the spring 2017.
Completes the Mind Over Matter; Healthy Bowels, Healthy Bladder workshop in the fall 2017.
Outcomes
Primary Outcome Measures
Symptom Improvement
Patient Global Impression of Improvement (PGI-I) regarding bladder or bowel incontinence
Secondary Outcome Measures
Pelvic Floor Distress Inventory-20
validated instrument
Geriatric Self-Efficacy for Urinary Incontinence (GSE-UI)
validated instrument
Barriers to Care-seeking for Accidental Bowel Leakage (BCABL)
validated instrument
Barriers to Incontinence Care-seeking (BICS-Q)
validated instrument
Full Information
NCT ID
NCT03140852
First Posted
May 2, 2017
Last Updated
December 20, 2021
Sponsor
University of Wisconsin, Madison
Collaborators
Wisconsin Partnership Program, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1. Study Identification
Unique Protocol Identification Number
NCT03140852
Brief Title
Community-Based Continence Promotion: Sustaining Healthy Aging in Place (SHAIP) Through Mind Over Matter (MOM)
Acronym
SHAIP
Official Title
Community-Based Continence Promotion: Sustaining Healthy Aging in Place (SHAIP) Through Mind Over Matter (MOM)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
April 25, 2017 (Actual)
Primary Completion Date
November 1, 2017 (Actual)
Study Completion Date
November 1, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
Collaborators
Wisconsin Partnership Program, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fecal Incontinence in Old Age, Urinary Incontinence in Old Age
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
122 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Active Comparator
Arm Description
Completes the Mind Over Matter; Healthy Bowels, Healthy Bladder workshop in the spring 2017.
Arm Title
Control
Arm Type
Other
Arm Description
Completes the Mind Over Matter; Healthy Bowels, Healthy Bladder workshop in the fall 2017.
Intervention Type
Behavioral
Intervention Name(s)
Mind Over Matter; Healthy Bowels, Healthy Bladder
Intervention Description
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.
Primary Outcome Measure Information:
Title
Symptom Improvement
Description
Patient Global Impression of Improvement (PGI-I) regarding bladder or bowel incontinence
Time Frame
3 months after treatment group completes intervention
Secondary Outcome Measure Information:
Title
Pelvic Floor Distress Inventory-20
Description
validated instrument
Time Frame
3 months after treatment group completes intervention
Title
Geriatric Self-Efficacy for Urinary Incontinence (GSE-UI)
Description
validated instrument
Time Frame
3 months after treatment group completes intervention
Title
Barriers to Care-seeking for Accidental Bowel Leakage (BCABL)
Description
validated instrument
Time Frame
3 months after treatment group completes intervention
Title
Barriers to Incontinence Care-seeking (BICS-Q)
Description
validated instrument
Time Frame
3 months after treatment group completes intervention
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
self-representation of gender identity
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heidi Brown, MD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin-Madison School of Medicine and Public Health
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31403596
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.
Results Reference
result
Learn more about this trial
Community-Based Continence Promotion: Sustaining Healthy Aging in Place (SHAIP) Through Mind Over Matter (MOM)
We'll reach out to this number within 24 hrs