Tailoring Online Continence Promotion

Study Overview
=================
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.

Official Title
-----------------
Tailoring Online Continence Promotion for Women

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

Intervention / Treatment
-----------------
* Behavioral: Online Continence promotion program without tailoring
* Behavioral: Online Continence promotion program with tailoring


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Online continence promotion program without tailoring<br>Participants will be allocated to the online continence promotion program without tailoring. | Behavioral: Online Continence promotion program without tailoring<br>* 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.<br>* Other names: Mind Over Matter; Healthy Bowels, Healthy Bladder (MOM) online without tailoring;|
| Experimental: Online continence promotion program with tailoring<br>Participants will be allocated to the online continence promotion program with tailoring. | Behavioral: Online Continence promotion program with tailoring<br>* 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.<br>* Other names: Mind Over Matter; Healthy Bowels, Healthy Bladder (MOM) online with tailoring;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 0-4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported behavior changes: change in the frequency of pelvic floor muscle exercises | Frequency of pelvic floor muscle exercises | Baseline, 4, 12, and 24 weeks | 
| 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. | Baseline, 4, and 24 weeks | 
| 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. | Baseline, 4, and 24 weeks | 
| 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. | Baseline, 4, and 24 weeks | 
| 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. | Baseline and 24 weeks | 
| 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. | Baseline and 24 weeks | 
| 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) | Baseline, 4, 12, and 24 weeks | 
| 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 | Baseline, 4, 12, and 24 weeks | 
| 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. | Baseline, 4, 12, and 24 weeks | 
| 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) | 4 and 24 weeks | 
| 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) | 4 and 24 weeks | 
| 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 | 4 and 24 weeks | 
| 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. | Baseline, 4, 12, and 24 weeks |