Tailoring Online Continence Promotion

Not Applicable

Completed

Conditions: Urinary Incontinence in Old Age
Fecal Incontinence in Old Age

Interventions: Behavioral: Online Continence promotion program with tailoring
Behavioral: Online Continence promotion program without tailoring

Registration Number: NCT05183217

Lead Sponsor: University of Wisconsin, Madison

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 445

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Online continence promotion program with tailoring	Online Continence promotion program with tailoring	Participants will be allocated to the online continence promotion program with tailoring.
Online continence promotion program without tailoring	Online Continence promotion program without tailoring	Participants will be allocated to the online continence promotion program without tailoring.

Primary Outcome Measures

Name	Time	Method
User Engagement With Online Mind Over Matter (MOM)	0-4 weeks	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

Name	Time	Method
Self-reported Behavior Changes: Change in the Frequency of Pelvic Floor Muscle Exercises	Baseline, 4, 12, and 24 weeks	Frequency of pelvic floor muscle exercises
Differences in Scores of the Geriatric Index for Urinary Incontinence (GSE-UI)	Baseline, 4, and 24 weeks	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	Baseline, 4, and 24 weeks	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	Baseline, 4, and 24 weeks	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)	Baseline and 24 weeks	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)	Baseline and 24 weeks	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)	Baseline, 4, 12, and 24 weeks	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)	Baseline, 4, 12, and 24 weeks	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)	Baseline, 4, 12, and 24 weeks	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)	4 and 24 weeks	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)	4 and 24 weeks	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)	4 and 24 weeks	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)	Baseline, 4, 12, and 24 weeks	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.