Fecal Incontinence in Old Age, Urinary Incontinence in Old Age
Conditions
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.
Interventions
BEHAVIORALOnline 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.
BEHAVIORALOnline 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.
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Wisconsin, Madison
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
50 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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. |
| 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. |
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Self-reported Behavior Changes: Change in Fluid Intake | Baseline, 4, 12, and 24 weeks | Self-reported behavior changes: fluid intake |
| Self-reported Behavior Changes: Change in Fiber Intake | Baseline, 4, 12, and 24 weeks | Self-reported behavior changes: change in fiber intake |
| Self-reported Coping Changes: Change in Types of Pad Used | Baseline, 4, 12, and 24 weeks | Self-reported coping changes: change in types of pad used |
| Self-reported Coping Changes: Change in Number of Pads Used | Baseline, 4, 12, and 24 weeks | Self-reported coping changes: change in number of pads used |
| Self-reported Changes: Change in the Money-spent on Buying Products to Manage Their Incontinence | Baseline, 4, 12, and 24 weeks | 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. |
| Self-reported Behavior Changes: Change in Body Mass Index (BMI) | Baseline, 4, 12, and 24 weeks | 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. |
| Program Use Metrics | Baseline to 24 weeks | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Online Continence Promotion Program Without Tailoring Participants will be allocated to the online continence promotion program without tailoring.
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. | 226 |
| Online Continence Promotion Program With Tailoring Participants will be allocated to the online continence promotion program with tailoring.
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. | 219 |
| Total | 445 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Online Continence Promotion Program Without Tailoring | Total | Online Continence Promotion Program With Tailoring |
|---|---|---|---|
| Age, Continuous | 58 years | 58 years | 58 years |
| Body mass index | 28 kg/m^2 | 27.5 kg/m^2 | 27 kg/m^2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 9 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 219 Participants | 431 Participants | 212 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 5 Participants | 3 Participants |
| Height | 165 Centimeters | 165 Centimeters | 165 Centimeters |
| Race (NIH/OMB) American Indian or Alaska Native | 4 Participants | 6 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 6 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 41 Participants | 75 Participants | 34 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 6 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) White | 174 Participants | 349 Participants | 175 Participants |
| Region of Enrollment United States | 226 participants | 444 participants | 219 participants |
| Sex: Female, Male Female | 226 Participants | 445 Participants | 219 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Weight | 77 kilograms | 76 kilograms | 75 kilograms |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 225 | 0 / 219 |
| other Total, other adverse events | 0 / 225 | 0 / 219 |
| serious Total, serious adverse events | 0 / 225 | 0 / 219 |
Outcome results
Primary
User Engagement With Online Mind Over Matter (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.
Time frame: 0-4 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Online Continence Promotion Program Without Tailoring | User Engagement With Online Mind Over Matter (MOM) | 17 Participants |
| Online Continence Promotion Program With Tailoring | User Engagement With Online Mind Over Matter (MOM) | 37 Participants |
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)
Time frame: 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
Time frame: 4 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)
Time frame: 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.
Time frame: Baseline, 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.
Time frame: Baseline, 4, 12, 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.
Time frame: Baseline 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.
Time frame: Baseline 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.
Time frame: Baseline, 4, 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)
Time frame: 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.
Time frame: 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
Time frame: Baseline, 4, 12, 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.
Time frame: Baseline, 4, and 24 weeks
Secondary
Self-reported Behavior Changes: Change in the Frequency of Pelvic Floor Muscle Exercises
Frequency of pelvic floor muscle exercises
Time frame: Baseline, 4, 12, and 24 weeks
Other Pre-specified
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).
Time frame: Baseline to 24 weeks
Other Pre-specified
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.
Time frame: Baseline, 4, 12, and 24 weeks
Other Pre-specified
Self-reported Behavior Changes: Change in Fiber Intake
Self-reported behavior changes: change in fiber intake
Time frame: Baseline, 4, 12, and 24 weeks
Other Pre-specified
Self-reported Behavior Changes: Change in Fluid Intake
Self-reported behavior changes: fluid intake
Time frame: Baseline, 4, 12, and 24 weeks
Other Pre-specified
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.
Time frame: Baseline, 4, 12, and 24 weeks
Other Pre-specified
Self-reported Coping Changes: Change in Number of Pads Used
Self-reported coping changes: change in number of pads used
Time frame: Baseline, 4, 12, and 24 weeks
Other Pre-specified
Self-reported Coping Changes: Change in Types of Pad Used
Self-reported coping changes: change in types of pad used
Time frame: Baseline, 4, 12, and 24 weeks