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Tailoring Online Continence Promotion (TOCP)

Primary Purpose

Urinary Incontinence in Old Age, Fecal Incontinence in Old Age

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Online Continence promotion program without tailoring
Online Continence promotion program with tailoring
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Incontinence in Old Age

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Female
  • 50 years or older
  • Can read & write English
  • Can use email
  • Has access to an Internet-connected device to use the online program

Exclusion Criteria:

  • Dementia
  • Neurologic or musculoskeletal conditions in which pelvic floor muscle exercises are contraindicated
  • Hematuria or bloody stools within last 6 months that has not been evaluated by a medical professional

Sites / Locations

  • University of Wisconsin-Madison School of Medicine and Public Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Online continence promotion program without tailoring

Online continence promotion program with tailoring

Arm Description

Participants will be allocated to the online continence promotion program without tailoring.

Participants will be allocated to the online continence promotion program with tailoring.

Outcomes

Primary Outcome Measures

User engagement with online MOM
Proportion of participants who engage with online MOM at least 4 times during weeks 0-4 in the group with (test) and without (control) tailoring.

Secondary Outcome Measures

Self-reported behavior changes: change in the frequency of pelvic floor muscle exercises
Frequency of pelvic floor muscle exercises
Differences in scores of the Geriatric Index for Urinary Incontinence (GSE-UI)
The Geriatric Index for Urinary Incontinence (GSE-UI) is a validated and clinically responsive instrument for older women with urinary incontinence. Participants select a 0-10 score for each of the 12 items, with total scores ranging from 0-120. A higher score is indicative of a higher level of self-efficacy related to urinary incontinence.
Differences in responses to the Generalized Self-Efficacy scale adapted for MOM program
Previously, in consultation with Dr. Ralf Schwarzer (Health Action Process Approach developer), the investigators adapted the Generalized Self Efficacy scale for behaviors related to continence promotion (such as pelvic floor muscle exercises).10-items are scored on a 4 point likert scale from 1 (not true at all) to 4 (exactly true) for a total range of scores from 10-40 where higher scores indicate higher self-efficacy.
Program Specific Health Action Process Approach Survey Responses reported as binary outcomes
Number of Participants who report high vs low risk perception, positive vs negative outcome expectations, specific intentions, action or coping plans, barriers and facilitators for health on the program-specific survey of other Health Action Process Approach components.
Differences in scores of the Barriers to Incontinence Care-Seeking Questionnaire (BICS-Q)
The Barriers to Incontinence Care-Seeking Questionnaire (BICS-Q) contains 14-items framed on a 4-point Likert scale and is validated in women with urinary incontinence. Mean score will be reported, ranging from 1-4 where higher scores indicate increased barriers.
Differences in scores of the Barriers to Care-seeking for Accidental Bowel Leakage (BCABL)
The Barriers to Care-seeking for Accidental Bowel Leakage (BCABL) has been validated in women with bowel incontinence. BCABL contains 16 questions framed on a 4-point Likert scale (strongly disagree, somewhat disagree, somewhat agree, strongly agree), for a total possible range of scores from 16-64 where higher scores indicate increased barriers.
Differences in scores of the International Consultation on Incontinence Questionnaire-Urinary Incontinence (ICIQ-UI)
ICIQ-UI is a subjective measure of severity of urinary loss and quality of life for those with urinary incontinence. It is scored on a scale from 0-21. Based on the score participant can be placed in four severity categories: slight (1-5), moderate (6-12), severe (13-18) and very severe (19-21)
Differences in scores of the St. Mark's Incontinence Scale (SMIS) (aka Vaizey)
St. Mark's Incontinence Scale (aka Vaizey) will be used to assess the severity and the outcome of MOM intervention Never: no episodes in the past 4 weeks rarely: 1 episode in the past 4 weeks sometimes: > 1 episode in the past 4 weeks, but,1 a week; Weekly: 1 or more episodes a week but,1 a day Daily: 1 or more episodes a day Scores will be assigned for each row (Never=0, Rarely=1, Sometimes=2, Weekly=3, Daily=4 ) Score will be added from each row. Cumulative minimum score=0 perfect continence; Cumulative maximum score will be 24= totally incontinence
Differences in scores of the Pelvic Floor Impact Questionnaire Short Form (PFIQ-7)
The Pelvic Floor Impact Questionnaire Short Form (PFIQ-7) is a widely-used validated instrument that assesses condition-specific quality of life. Scores range from 0-300 with higher scores indicating higher symptom bother.
Change in the response of Global patient satisfaction question (PSQ)
Patient satisfaction will be measured with the question: How satisfied are you with your progress in this program? (completely, some-what, not at all)
Change in patient estimated percent improvement (EPI)
For EPI, Patients will be asked to estimate how much better they were on a scale from 0% (no better) to 100%(completely better)
Change in response on global perception of improvement (GPI)
Global perception of improvement (GPI) is a tool for Global Rating of Patient Satisfaction and Perceptions of Improvement. Question asked: Overall, do you feel that you are? Response can be chosen from the options: Much Better, Better, About the same, Worse, Much worse
Differences in scores of the 12-item Short Form Health Survey (SF-12)
The 12-item Short Form Health Survey (SF-12) is a validated health-related quality of life questionnaire from which mental and physical component scores can be calculated. Scores on the PCS-12 (Physical Score): range from 23.99938 (difference from USA average: -26.00062) to 56.57706 (difference from USA average: 6.57706). Scores on the MCS-12 (Mental Score): range from 19.06444 (difference from USA average: -30.93556) to 60.75781 (difference from USA average: 10.75781). For both components, higher scores indicate better health-related quality of life.

Full Information

First Posted
December 20, 2021
Last Updated
September 27, 2023
Sponsor
University of Wisconsin, Madison
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT05183217
Brief Title
Tailoring Online Continence Promotion
Acronym
TOCP
Official Title
Tailoring Online Continence Promotion for Women
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
Collaborators
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
This project seeks to understand whether, and how, tailoring an online continence intervention can increase engagement and uptake of health behaviors known to improve bladder and bowel symptoms.
Detailed Description
The investigators will conduct a two-arm, parallel, randomized, controlled trial (RCT) comparing an online continence promotion program with standard weekly reminders (control arm) to an online continence promotion program with tailoring (treatment arm) to determine the impact of tailoring on program engagement. Women in the treatment arm will receive tailored content and digital reminders for 24 weeks based on their individual characteristics, symptoms, and behaviors assessed at baseline, with reassessment of key inputs every 2 weeks resulting in re-tailored outputs. Participants will complete electronic surveys at enrollment, 4, 12, and 24 weeks. To contextualize the findings from all 3 aims, a subset of participants will be invited to complete semi-structured qualitative interviews about their engagement with the program, their adoption of health behaviors, and their perceived barriers to and facilitators of engagement and behavior change.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence in Old Age, Fecal Incontinence in Old Age

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
348 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Online continence promotion program without tailoring
Arm Type
Active Comparator
Arm Description
Participants will be allocated to the online continence promotion program without tailoring.
Arm Title
Online continence promotion program with tailoring
Arm Type
Experimental
Arm Description
Participants will be allocated to the online continence promotion program with tailoring.
Intervention Type
Behavioral
Intervention Name(s)
Online Continence promotion program without tailoring
Other Intervention Name(s)
Mind Over Matter; Healthy Bowels, Healthy Bladder (MOM) online without tailoring
Intervention Description
The online continence promotion program has five sections (Introduction, Exercise, Bladder, Bowels, Care Seeking) that build knowledge, self-efficacy, and skills to set action and coping plans relevant to a participant's symptoms. This online program is based on an in-person, small-group program that has demonstrated effectiveness to improve both urinary and bowel incontinence in women age 50 and above. Participants will receive automated weekly reminders reminding them to re-visit the program, regardless of their individual user activity.
Intervention Type
Behavioral
Intervention Name(s)
Online Continence promotion program with tailoring
Other Intervention Name(s)
Mind Over Matter; Healthy Bowels, Healthy Bladder (MOM) online with tailoring
Intervention Description
The online continence promotion program has five sections (Introduction, Exercise, Bladder, Bowels, Care Seeking) that build knowledge, self-efficacy, and skills to set action and coping plans relevant to a participant's symptoms. This online program is based on an in-person, small-group program that has demonstrated effectiveness to improve both urinary and bowel incontinence in women age 50 and above. Participants will receive tailored "output" (personalized cues, emphasis on relevant content, individualized and tailored reminders about their goals) based on a computer algorithm incorporating unique user "inputs" (individual factors). Inputs will be reassessed every 2 weeks for retailoring so that personalization evolves over the course of the intervention.
Primary Outcome Measure Information:
Title
User engagement with online MOM
Description
Proportion of participants who engage with online MOM at least 4 times during weeks 0-4 in the group with (test) and without (control) tailoring.
Time Frame
0-4 weeks
Secondary Outcome Measure Information:
Title
Self-reported behavior changes: change in the frequency of pelvic floor muscle exercises
Description
Frequency of pelvic floor muscle exercises
Time Frame
Baseline, 4, 12, and 24 weeks
Title
Differences in scores of the Geriatric Index for Urinary Incontinence (GSE-UI)
Description
The Geriatric Index for Urinary Incontinence (GSE-UI) is a validated and clinically responsive instrument for older women with urinary incontinence. Participants select a 0-10 score for each of the 12 items, with total scores ranging from 0-120. A higher score is indicative of a higher level of self-efficacy related to urinary incontinence.
Time Frame
Baseline, 4, and 24 weeks
Title
Differences in responses to the Generalized Self-Efficacy scale adapted for MOM program
Description
Previously, in consultation with Dr. Ralf Schwarzer (Health Action Process Approach developer), the investigators adapted the Generalized Self Efficacy scale for behaviors related to continence promotion (such as pelvic floor muscle exercises).10-items are scored on a 4 point likert scale from 1 (not true at all) to 4 (exactly true) for a total range of scores from 10-40 where higher scores indicate higher self-efficacy.
Time Frame
Baseline, 4, and 24 weeks
Title
Program Specific Health Action Process Approach Survey Responses reported as binary outcomes
Description
Number of Participants who report high vs low risk perception, positive vs negative outcome expectations, specific intentions, action or coping plans, barriers and facilitators for health on the program-specific survey of other Health Action Process Approach components.
Time Frame
Baseline, 4, and 24 weeks
Title
Differences in scores of the Barriers to Incontinence Care-Seeking Questionnaire (BICS-Q)
Description
The Barriers to Incontinence Care-Seeking Questionnaire (BICS-Q) contains 14-items framed on a 4-point Likert scale and is validated in women with urinary incontinence. Mean score will be reported, ranging from 1-4 where higher scores indicate increased barriers.
Time Frame
Baseline and 24 weeks
Title
Differences in scores of the Barriers to Care-seeking for Accidental Bowel Leakage (BCABL)
Description
The Barriers to Care-seeking for Accidental Bowel Leakage (BCABL) has been validated in women with bowel incontinence. BCABL contains 16 questions framed on a 4-point Likert scale (strongly disagree, somewhat disagree, somewhat agree, strongly agree), for a total possible range of scores from 16-64 where higher scores indicate increased barriers.
Time Frame
Baseline and 24 weeks
Title
Differences in scores of the International Consultation on Incontinence Questionnaire-Urinary Incontinence (ICIQ-UI)
Description
ICIQ-UI is a subjective measure of severity of urinary loss and quality of life for those with urinary incontinence. It is scored on a scale from 0-21. Based on the score participant can be placed in four severity categories: slight (1-5), moderate (6-12), severe (13-18) and very severe (19-21)
Time Frame
Baseline, 4, 12, and 24 weeks
Title
Differences in scores of the St. Mark's Incontinence Scale (SMIS) (aka Vaizey)
Description
St. Mark's Incontinence Scale (aka Vaizey) will be used to assess the severity and the outcome of MOM intervention Never: no episodes in the past 4 weeks rarely: 1 episode in the past 4 weeks sometimes: > 1 episode in the past 4 weeks, but,1 a week; Weekly: 1 or more episodes a week but,1 a day Daily: 1 or more episodes a day Scores will be assigned for each row (Never=0, Rarely=1, Sometimes=2, Weekly=3, Daily=4 ) Score will be added from each row. Cumulative minimum score=0 perfect continence; Cumulative maximum score will be 24= totally incontinence
Time Frame
Baseline, 4, 12, and 24 weeks
Title
Differences in scores of the Pelvic Floor Impact Questionnaire Short Form (PFIQ-7)
Description
The Pelvic Floor Impact Questionnaire Short Form (PFIQ-7) is a widely-used validated instrument that assesses condition-specific quality of life. Scores range from 0-300 with higher scores indicating higher symptom bother.
Time Frame
Baseline, 4, 12, and 24 weeks
Title
Change in the response of Global patient satisfaction question (PSQ)
Description
Patient satisfaction will be measured with the question: How satisfied are you with your progress in this program? (completely, some-what, not at all)
Time Frame
4 and 24 weeks
Title
Change in patient estimated percent improvement (EPI)
Description
For EPI, Patients will be asked to estimate how much better they were on a scale from 0% (no better) to 100%(completely better)
Time Frame
4 and 24 weeks
Title
Change in response on global perception of improvement (GPI)
Description
Global perception of improvement (GPI) is a tool for Global Rating of Patient Satisfaction and Perceptions of Improvement. Question asked: Overall, do you feel that you are? Response can be chosen from the options: Much Better, Better, About the same, Worse, Much worse
Time Frame
4 and 24 weeks
Title
Differences in scores of the 12-item Short Form Health Survey (SF-12)
Description
The 12-item Short Form Health Survey (SF-12) is a validated health-related quality of life questionnaire from which mental and physical component scores can be calculated. Scores on the PCS-12 (Physical Score): range from 23.99938 (difference from USA average: -26.00062) to 56.57706 (difference from USA average: 6.57706). Scores on the MCS-12 (Mental Score): range from 19.06444 (difference from USA average: -30.93556) to 60.75781 (difference from USA average: 10.75781). For both components, higher scores indicate better health-related quality of life.
Time Frame
Baseline, 4, 12, and 24 weeks
Other Pre-specified Outcome Measures:
Title
Program use metrics
Description
Comparison of specific program use metrics (number of, minutes spent on, and average intervals between program sessions accessed weekly; number of and specific components accessed) between the two groups and patterns of program use (such as tracking and reminders).
Time Frame
Baseline to 24 weeks
Title
Self-reported behavior changes: change in body mass index (BMI)
Description
Proportion of participants in the treatment group compared to the control group with a body mass index (BMI) >25mg/kg2 at baseline who report weight loss of at least 2 kg.
Time Frame
Baseline, 4, 12, and 24 weeks
Title
Self-reported behavior changes: change in fluid intake
Description
Self-reported behavior changes: fluid intake
Time Frame
Baseline, 4, 12, and 24 weeks
Title
Self-reported behavior changes: change in fiber intake
Description
Self-reported behavior changes: change in fiber intake
Time Frame
Baseline, 4, 12, and 24 weeks
Title
Self-reported coping changes: change in types of pad used
Description
Self-reported coping changes: change in types of pad used
Time Frame
Baseline, 4, 12, and 24 weeks
Title
Self-reported coping changes: change in number of pads used
Description
Self-reported coping changes: change in number of pads used
Time Frame
Baseline, 4, 12, and 24 weeks
Title
Self-reported changes: change in the money-spent on buying products to manage their incontinence
Description
It will be measured by asking participants question that how much money have they spent on products (such as pads, undergarments, or plugs) to manage their bladder and/or bowel symptoms in the last month.
Time Frame
Baseline, 4, 12, and 24 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Female 50 years or older Can read & write English Can use email Has access to an Internet-connected device to use the online program Exclusion Criteria: Dementia Neurologic or musculoskeletal conditions in which pelvic floor muscle exercises are contraindicated Hematuria or bloody stools within last 6 months that has not been evaluated by a medical professional
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Madeline K Moureau, BS
Phone
608-417-6493
Email
moureau@wisc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Sharon Blohowiak, MS
Phone
608-417-6957
Email
sblohowiak@wisc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Megan Piper, PhD
Organizational Affiliation
University of Wisconsin Dept of Medicine
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
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Madeline K Moureau, BS
Phone
608-417-6493
Email
moureau@wisc.edu
First Name & Middle Initial & Last Name & Degree
Sharon Blohowiak, MS
Phone
608-417-6957
Email
sblohowiak@wisc.edu
First Name & Middle Initial & Last Name & Degree
Megan Piper, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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