Tailoring Online Continence Promotion

Urinary Incontinence in Old Age Clinical Trial

— TOCP  

Official title:

Tailoring Online Continence Promotion for Women

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05183217
• Other study ID #: 2021-1555
• Secondary ID: 1R01DK128349-01A
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 30, 2023
• Est. completion date: September 30, 2024

Study information

• Verified date: April 2024
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 443
• Est. completion date: September 30, 2024
• Est. primary completion date: April 26, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Online Continence promotion program without tailoring
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.
• Online Continence promotion program with tailoring
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.

Locations

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

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Program use metrics	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).	Baseline to 24 weeks
Other	Self-reported behavior changes: change in body mass index (BMI)	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.	Baseline, 4, 12, and 24 weeks
Other	Self-reported behavior changes: change in fluid intake	Self-reported behavior changes: fluid intake	Baseline, 4, 12, and 24 weeks
Other	Self-reported behavior changes: change in fiber intake	Self-reported behavior changes: change in fiber intake	Baseline, 4, 12, and 24 weeks
Other	Self-reported coping changes: change in types of pad used	Self-reported coping changes: change in types of pad used	Baseline, 4, 12, and 24 weeks
Other	Self-reported coping changes: change in number of pads used	Self-reported coping changes: change in number of pads used	Baseline, 4, 12, and 24 weeks
Other	Self-reported changes: change in the money-spent on buying products to manage their incontinence	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.	Baseline, 4, 12, and 24 weeks
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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