Educational-Medical-Behavioral Treatment of Fecal Inconti... | NCT01717456

ID	Type	Description	Link
R01HS018695	U.S. AHRQ Grant/Contract		View source

Name	Class
Agency for Healthcare Research and Quality (AHRQ)	FED

Label	Type	Description	Intervention Names
Educational-Medical-Behavioral	Active Comparator	Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives or anti-diarrheals [Miralax 1-2 packets (17-34 g)/day or Imodium 0.5-2 tablets (1-4 mg)/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, daily diary, and protective pads or garments [as needed].	Other: Education Dietary Supplement: Fiber supplements Drug: Laxatives or anti-diarrheals Behavioral: Pelvic floor muscle exercises Behavioral: Tips on how to prevent fecal incontinence Behavioral: Daily diary Other: Protective pads or garments
Standard Care	Placebo Comparator	Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].	Dietary Supplement: Fiber supplements Behavioral: Daily diary Other: Protective pads or garments

Name	Type	Description	Arm Group Labels	Other Names
Education	Other	Patient and caregiver will be taught which muscles are used in continence and defecation through the use of a training manual and anatomical drawings.	Educational-Medical-Behavioral

Measure	Description	Time Frame
Fecal Incontinence Severity Index (FISI) at End of Treatment	At the end of treatment, the FISI requires the patient to report the frequency of occurrence of 4 types of fecal incontinence (solid, liquid, mucus, and gas incontinence) in the past month. These four responses are multiplied by empirically derived patient weights and the values are added together. Range of scores is 0-61. Higher scores show more severe fecal incontinence.	End of Treatment (Week 6)
Fecal Incontinence Severity Index (FISI) at Follow-Up (FU)	At follow up 6 months after the end of treatment, the subject reports the frequency of occurrence of 4 types of fecal incontinence (solid, liquid, mucus, and gas incontinence) in the past month. These four responses are multiplied by empirically derived patient weights and the values are added together. Range is 0-61. No data is available to interpret the scale as mild, moderate, or severe fecal incontinence.	6 months after (6-Week) treatment ends

Measure	Description	Time Frame
Adequate Relief of Fecal Incontinence at End of Treatment	At the end of treatment, the subject is asked, "Compared to before you started home health care, have you experienced adequate relief of your fecal incontinence symptoms? [Responses: yes or no]". A responder is anyone answering yes. A treatment would be judged successful if there was at least 10% more responders in the active compared to the control groups.

Measure	Description	Time Frame
Cognitive Status at End of Treatment	OASIS question M1700: Cognitive functioning: Patient's current (day of assessment) level of alertness, orientation, comprehension, concentration, and immediate memory for simple commands. Measure as treatment moderator. Response categories are: 0 - Alert/oriented, able to focus and shift attention, comprehends and recalls task directions independently. - Requires prompting (cuing, repetition, reminders) only under stressful or unfamiliar conditions. - Requires assistance and some direction in specific situations (e.g., on all tasks involving shifting of attention), or consistently requires low stimulus environment due to distractibility. - Requires considerable assistance in routine situations. Is not alert and oriented or is unable to shift attention and recall directions more than half the time. - Totally dependent due to disturbances uch as constant disorientation, coma, persistent vegetative stte, or delirium.

Name	Affiliation	Role
William E Whitehead, PhD	University of North Carolina, Chapel Hill	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
University of North Carolina at Chapel Hill		Chapel Hill	North Carolina	27599-7080	United States

ID	Title	Description
FG000	Educational-Medical-Behavioral	Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives or anti-diarrheals [Miralax 1-2 packets (17-34 g)/day or Imodium 0.5-2 tablets (1-4 mg)/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, daily diary, and protective pads or garments [as needed].

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

- ParticipantsBG00011
- ParticipantsBG0018
- ParticipantsBG00219

Title	Measurements

Sex: Female, Male

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG00011 ParticipantsBG0018 ParticipantsBG002

Race (NIH/OMB)

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG00011 ParticipantsBG0018 ParticipantsBG002

Fecal Incontinence Severity Index (FISI) at Baseline

Subjects rated the frequency of 4 types of stool leakage (gas, mucus, liquid, and solid) over the prior month on a 6-stepscale. Possible responses were never, 1-3 times/ month, once/week, 2 or more times/week, once/day, and 2 or more times/day. Based on the average quality of life impact scores assigned by a reference group of 34 subjects with fecal incontinence, weights were assigned to each of these 4 responses and added together for a sum score. Range is 0-61. No guidance on what defines mild, moderate, or severe is available. Higher scores show more severe fecal incontinence.

Mean

Standard Deviation

units on a scale

Title	Denominators	Categories
	ParticipantsBG00011 ParticipantsBG001

Manchester Health Questionnaire (MHQ) Severity Scale at Baseline

The MHQ (Br J Obstetrics & Gynecol 2001;108:1057-67) is a 32-item questionnaire that assesses the impact of anal incontinence on quality of life in women. Each item is answered on a 5-point ordinal scale. Eight of 9 subscales were used: incontinence impact, role, physical function, social function, personal function, emotional problems, sleep/energy, and severity. A total score was calculated by summing the subscales. The range of scores of each domain is 0-100, and higher scores indicate greater impairment. Means and SDs for a reference group of 154 FI patients were published.

Mean

Standard Deviation

units on a scale

Title	Denominators	Categories
	ParticipantsBG00011 ParticipantsBG001

MHQ Incontinence Impact at Baseline

The MHQ (Br J Obstetrics & Gynecol 2001;108:1057-67) is a 32-item questionnaire that assesses the impact of anal incontinence on quality of life in women. Each item is answered on a 5-point ordinal scale. Eight of 9 subscales were used: incontinence impact, role, physical function, social function, personal function, emotional problems, sleep/energy, and severity. A total score was calculated by summing the subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.

Mean

Standard Deviation

units on a scale

Title	Denominators	Categories
	ParticipantsBG00011 ParticipantsBG001

MHQ Role Limitations at Baseline

The MHQ (Br J Obstetrics & Gynecol 2001;108:1057-67) is a 32-item questionnaire that assesses the impact of anal incontinence on quality of life in women. Each item is answered on a 5-point ordinal scale. Eight of 9 subscales were used: incontinence impact, role, physical function, social function, personal function, emotional problems, sleep/energy, and severity. A total score was calculated by summing the subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.

Mean

Standard Deviation

units on a scale

Title	Denominators	Categories
	ParticipantsBG00011 ParticipantsBG001

MHQ Physical Limitations at Baseline

The MHQ (Br J Obstetrics & Gynecol 2001;108:1057-67) is a 32-item questionnaire that assesses the impact of anal incontinence on quality of life in women. Each item is answered on a 5-point ordinal scale. Eight of 9 subscales were used: incontinence impact, role, physical function, social function, personal function, emotional problems, sleep/energy, and severity. A total score was calculated by summing the subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.

Mean

Standard Deviation

units on a scale

Title	Denominators	Categories
	ParticipantsBG00011 ParticipantsBG001

MHQ Social Limitations at Baseline

The MHQ (Br J Obstetrics & Gynecol 2001;108:1057-67) is a 32-item questionnaire that assesses the impact of anal incontinence on quality of life in women. Each item is answered on a 5-point ordinal scale. Eight of 9 subscales were used: incontinence impact, role, physical function, social function, personal function, emotional problems, sleep/energy, and severity. A total score was calculated by summing the subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.

Mean

Standard Deviation

units on a scale

Title	Denominators	Categories
	ParticipantsBG00011 ParticipantsBG001

MHQ Personal Relationships at Baseline

The MHQ (Br J Obstetrics & Gynecol 2001;108:1057-67) is a 32-item questionnaire that assesses the impact of anal incontinence on quality of life in women. Each item is answered on a 5-point ordinal scale. Eight of 9 subscales were used: incontinence impact, role, physical function, social function, personal function, emotional problems, sleep/energy, and severity. A total score was calculated by summing the subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.

Mean

Standard Deviation

units on a scale

Title	Denominators	Categories
	ParticipantsBG00011 ParticipantsBG001

MHQ Emotions at Baseline

The MHQ (Br J Obstetrics & Gynecol 2001;108:1057-67) is a 32-item questionnaire that assesses the impact of anal incontinence on quality of life in women. Each item is answered on a 5-point ordinal scale. Eight of 9 subscales were used: incontinence impact, role, physical function, social function, personal function, emotional problems, sleep/energy, and severity. A total score was calculated by summing the subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.

Mean

Standard Deviation

units on a scale

Title	Denominators	Categories
	ParticipantsBG00011 ParticipantsBG001

MHQ Sleep Energy at Baseline

The MHQ (Br J Obstetrics & Gynecol 2001;108:1057-67) is a 32-item questionnaire that assesses the impact of anal incontinence on quality of life in women. Each item is answered on a 5-point ordinal scale. Eight of 9 subscales were used: incontinence impact, role, physical function, social function, personal function, emotional problems, sleep/energy, and severity. A total score was calculated by summing the subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.

Mean

Standard Deviation

units on a scale

Title	Denominators	Categories
	ParticipantsBG00011 ParticipantsBG001

Zarit Caregiver Burden Scale at Baseline

The Zarit Caregiver Burden Interview is a 22-item questionnaire to assess the perceived burden of taking care of another ill or physically impaired person. All items are answered on a 5-step ordinal scale (from never to nearly always). Higher scores depict greater burden on the family. The total score range is from 0 to 66.

Mean

Standard Deviation

units on a scale

Title	Denominators	Categories
	ParticipantsBG00011 ParticipantsBG0018 ParticipantsBG002

Frequency of fecal incontinence at Baseline

OASIS question M1620. 6-level ordinal scale.

0 = Never or rarely incontinent for stool

= Less than 1/week
= 1-3 days/week
= 4-6 days/week
= Daily stool leakage
= Multiple times per day

Higher scores represent worse outcomes.

Data were missing for 2/11 in Group A and for 6/8 in Group B.

Data were missing for 2/11 in Group A and 6/8 in Group B.

Median

Full Range

units on a scale

Title	Denominators	Categories
	ParticipantsBG0009 ParticipantsBG0012

Urinary Continence Status at Baseline

OASIS Question M1610 is a 3-level ordinal scale.

0 = No urinary incontinence

= Incontinence for urine
= Patient requires catheter

Data are missing for 2/11 in Group A and 6/8 in Group B. Having a catheter is equivalent to having urinary incontinence; therefore, the investigators treated a 2 as equivalent to a 1.

Data were missing for 2/11 in Group A and 6/8 for Group B.

Median

Full Range

units on a scale

Title	Denominators	Categories
	ParticipantsBG0009 ParticipantsBG0012

Cognitive Function at Baseline

OASIS Question M1700. 5-level ordinal scale:

0 = Alert and oriented

= Requires prompting for unfamiliar activities
= Requires assistance when task demands shifting attention
= Requires assistance for routine tasks
= Totally dependent

Data missing for 2/11 in Group A and 6/8 in Group B. A higher number indicates a greater degree of cognitive impairment.

Data were missing for 2/11 in Group A and 6/8 for Group B.

Median

Full Range

units on a scale

Title	Denominators	Categories
	ParticipantsBG0009 ParticipantsBG001

Ambulation at Baseline

OASIS Question M1860 is a 7-level ordinal scale.

0 = Walks without assistance

= Uses cane or other one-hand assistive device
= Uses walker or other two-hand assistive device
= Able to walk with assistance
= Chair-fast but can wheel self around
= Chair-fast and requires assistance
= Bedfast

Higher scores indicate a greater degree of physical impairment.

Median

Full Range

units on a scale

Title	Denominators	Categories
	ParticipantsBG00011 ParticipantsBG0018 ParticipantsBG002

Ability to use toilet at Baseline

OASIS Question M1840 is a 5 level ordinal scale. Steps are:

0 = Independent self-toileting

= Uses toilet when reminded to do so
= Unable to reach toilet but can use a bedside commode
= Limited to use of a bedpan
= Totally dependent in toileting

Missing data for 2/11 in Group A and 6/8 in Group B.

Higher scores indicate a greater degree of impairment in toileting behavior.

Data were missing for 2/11 in Group A and 6/8 for Group B.

Median

Full Range

participants

Title	Denominators	Categories
	ParticipantsBG0009 ParticipantsBG001

When is patient anxious at Baseline?

OASIS Question M1720 is a 4-level ordinal scale. Responses are:

0 = Never

= Less than every day
= Daily but not constantly
= All the time

Higher scores indicate a greater level of anxiousness.

Median

Full Range

units on a scale

Title	Denominators	Categories
	ParticipantsBG00011 ParticipantsBG0018 ParticipantsBG002

Depression Screening at Baseline

OASIS Question M1730 has 4 discrete categories. Possible responses are:

0 = Patient was not screened for depression

= Screened by PHQ2 depression scale
= Meets criteria for further screening for depression
= Does not meet criteria for further screening

Higher scores indicate a greater level of depression.

Number

participants

Title	Denominators	Categories
Not screened for depression	ParticipantsBG00011 ParticipantsBG0018 ParticipantsBG002

Living Situation at Baseline

OASIS Question M1100 has 3 discrete categories which are:

1 = Lives alone 6 = Lives with another person 11 = Lives in assisted living

Scores are labels describing the patient's living situation.

Number

participants

Title	Denominators	Categories
Lives alone	ParticipantsBG00011 ParticipantsBG0018 ParticipantsBG002

Source of Assistance with ADLs at Baseline

OASIS Question M2100 has 5 discrete categories which are:

0 = No assistance needed

= Caregiver provides assistance for activities of daily living (ADLs)
= Caregiver needs training or support
= Caregiver is not likely to provide assistance
= Unclear if caregiver will provide assistance
= Assistance needed but none is available

Higher scores indicate a greater need for assistance with ADLs.

Number

participants

Title	Denominators	Categories
No assistance needed	ParticipantsBG00011 ParticipantsBG0018

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Fecal Incontinence Severity Index (FISI) at End of Treatment

At the end of treatment, the FISI requires the patient to report the frequency of occurrence of 4 types of fecal incontinence (solid, liquid, mucus, and gas incontinence) in the past month. These four responses are multiplied by empirically derived patient weights and the values are added together. Range of scores is 0-61. Higher scores show more severe fecal incontinence.

Analysis population includes all participants who provided end of treatment data to research assistants during a home visit. One subject from the EMB treatment did not provide data, and 1 subject from the SC group did not provide these data.

Posted

Mean

Standard Deviation

units on a scale

End of Treatment (Week 6)

ID	Title	Description
OG000	Educational-Medical-Behavioral	Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives or anti-diarrheals [miralax 1-2 packets (17-34 g)/day or Imodium 0.5-2 tablets (1-4 mg)/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, daily diary, and protective pads or garments [as needed].
OG001	Standard Care	Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].

Units	Counts
Participants	OG00010 OG0015

Title

Denominators

Categories

Title	Measurements
	OG00018.00± 10.30 OG00122.00± 9.17

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		t-test, 2 sided		.05	No adjustment for multiple comparisons.	Mean Difference (Final Values)	4.0	Standard Deviation	6.72	2-Sided	95							Superiority or Other

Primary

Fecal Incontinence Severity Index (FISI) at Follow-Up (FU)

At follow up 6 months after the end of treatment, the subject reports the frequency of occurrence of 4 types of fecal incontinence (solid, liquid, mucus, and gas incontinence) in the past month. These four responses are multiplied by empirically derived patient weights and the values are added together. Range is 0-61. No data is available to interpret the scale as mild, moderate, or severe fecal incontinence.

The analysis sample consists of all patients who provided data at the 6 month FU visit.

Posted

Mean

Standard Deviation

units on a scale

6 months after (6-Week) treatment ends

ID	Title	Description
OG000	Educational-Medical-Behavioral	Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
OG001	Standard Care	Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].

Secondary

Adequate Relief of Fecal Incontinence at End of Treatment

At the end of treatment, the subject is asked, "Compared to before you started home health care, have you experienced adequate relief of your fecal incontinence symptoms? [Responses: yes or no]". A responder is anyone answering yes. A treatment would be judged successful if there was at least 10% more responders in the active compared to the control groups.

Data not available for 1/11 Educational-Medical-Behavioral group subject and for 2/8 Standard Care subjects.

Posted

Number

participants

End of Treatment (Week 6)

ID	Title	Description
OG000	Educational-Medical-Behavioral	Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
OG001	Standard Care	Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].

Secondary

Adequate Relief of Fecal Incontinence at Follow Up

At follow up 6 months after the end of treatment, the subject is asked, "Compared to before you started home health care, have you experienced adequate relief of your fecal incontinence symptoms? [Responses: yes or no]". A responder to treatment is a subject who answers "yes". When applied to group analysis, a treatment is regarded as effective if the responder rate is at least 10% greater in the active treatment arm compared to the control arm. This measure is not recorded at baseline because it is undefined until treatment has been provided.

Data not available for 3/7 Educational-Medical-Behavioral group subject and for 2/2 Standard Care subjects.

Posted

Number

participants

6 months after (6-Week) treatment ends

ID	Title	Description
OG000	Educational-Medical-Behavioral	Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
OG001	Standard Care	Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].

Secondary

MHQ Severity Scale at End of Treatment

Quality of life scale specific to fecal incontinence. Severity is one of 8 MHQ subscales. This subscale has a range of 0 to 100. Higher scores indicate greater severity of QOL impact.

All subjects completing end of treatment home visit with research assistant.

Posted

Mean

Standard Deviation

units on a scale

End of Treatment (Week 6)

ID	Title	Description
OG000	Educational-Medical-Behavioral	Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
OG001	Standard Care	Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].

Units	Counts
Participants

Secondary

MHQ Severity Scale at Follow Up

Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0 to 100. Higher scores indicate greater impact on quality of life.

All subjects completing end of treatment home visit with research assistant.

Posted

Mean

Standard Deviation

units on a scale

6 months after (6-Week) treatment ends

ID	Title	Description
OG000	Educational-Medical-Behavioral	Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
OG001	Standard Care	Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].

Units	Counts
Participants

Secondary

Zarit Caregiver Burden Scale at End of Treatment

Validated questionnaire developed to assess the psychosocial and health burden experienced by a family caregiver of the identified patient. The 22-items ask about behaviors and feelings of caregivers on a 6-step ordinal scale (never to almost always). The scale is valid for caregivers of individuals with diverse chronic disabilities (dementia, advanced cancer, acquired brain injury). The scale has good internal consistency. Total scores range 0-66, and 21 or greater is interpreted as high burden (J Clin Epidemiol 2010;63:535-42). Subscales (role and personal strain) have been described but are unreliable so total scores were used.

Family caregivers of patients completing the study. Some caregivers declined or no caregiver was available.

Posted

Mean

Standard Deviation

units on a scale

End of Treatment (Week 6)

ID	Title	Description
OG000	Educational-Medical-Behavioral	Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives or anti-diarrheals [miralax 1-2 packets (17-34 g)/day or Imodium 0.5-2 tablets (1-4 mg)/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, daily diary, and protective pads or garments [as needed].
OG001	Standard Care	Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].

Secondary

Zarit Caregiver Burden Scale at Follow Up

Validated questionnaire developed to assess the psychosocial and health burden experienced by a family caregiver of the identified patient. The total score range is from 0 to 66. Higher scores indicate greater severity of burden on the family.

Family caregivers of patients completing the study. Some caregivers declined or no caregiver was available.

Posted

Mean

Standard Deviation

units on a scale

6 months after (6-Week) treatment ends

ID	Title	Description
OG000	Educational-Medical-Behavioral	Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives or anti-diarrheals [miralax 1-2 packets (17-34 g)/day or Imodium 0.5-2 tablets (1-4 mg)/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, daily diary, and protective pads or garments [as needed].
OG001	Standard Care	Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].

Units	Counts
Participants

Secondary

Fecal Incontinence Frequency at End of Treatment

OASIS question M1620: Bowel incontinence frequency. Response options are:

0 - Very rarely or never has bowel incontinence

- Less than once weekly
- One to three times weekly
- Four to six times weekly
- On a daily basis
- More often than once daily

Analysis population consists of all patients who provided data at the end of treatment visit. Data is missing for 2/11 in Group A and 6/8 in Group B.

Posted

Median

Full Range

units on a scale

End of Treatment (Week 6)

ID	Title	Description
OG000	Educational-Medical-Behavioral	Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
OG001	Standard Care	Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].

Units	Counts

Secondary

Urinary Incontinence Status Change From Baseline to End of Treatment

OASIS question M1610: Urinary incontinence or urinary catheter presence. Response options are:

0 - No incontinence or catheter (includes anuria or ostomy for urinary drainage)

- Patient is incontinent
- Patient requires a urinary catheter (i.e., external, indwelling, intermittent, suprapubic)

Analysis population consists of all patients who provided end of treatment data. Data were missing for 2/11 in Group A and 6/8 in Group B.

Posted

Median

Full Range

units on a scale

Baseline, end of treatment (week 6)

ID	Title	Description
OG000	Educational-Medical-Behavioral	Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
OG001	Standard Care	Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].

Secondary

Admission to Nursing Home at End of Treatment

Was patient admitted to a nursing home for one or more days at any time between enrollment and follow-up 7-8 months after treatment onset.

Analysis sample was all patients who provided data at end of treatment.

Posted

Number

participants

End of Treatment (Week 6)

ID	Title	Description
OG000	Educational-Medical-Behavioral	Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
OG001	Standard Care	Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].

Units	Counts
Participants

Secondary

MHQ Incontinence Impact at End of Treatment

Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.

All subjects completing end of treatment home visit with research assistant.

Posted

Mean

Standard Deviation

units on a scale

End of Treatment (Week 6)

ID	Title	Description
OG000	Educational-Medical-Behavioral	Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
OG001	Standard Care	Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].

Units	Counts
Participants

Secondary

MHQ Incontinence Impact at Follow Up

Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.

All subjects completing end of treatment home visit with research assistant.

Posted

Mean

Standard Deviation

units on a scale

6 months after (6-Week) treatment ends

ID	Title	Description
OG000	Educational-Medical-Behavioral	Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
OG001	Standard Care	Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].

Units	Counts
Participants

Secondary

MHQ Role Limitations at End of Treatment

Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.

All subjects completing end of treatment home visit with research assistant.

Posted

Mean

Standard Deviation

units on a scale

End of Treatment (Week 6)

ID	Title	Description
OG000	Educational-Medical-Behavioral	Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
OG001	Standard Care	Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].

Units	Counts
Participants

Secondary

MHQ Role Limitations at Follow Up

Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.

All subjects completing end of treatment home visit with research assistant.

Posted

Mean

Standard Deviation

units on a scale

6 months after (6-Week) treatment ends

ID	Title	Description
OG000	Educational-Medical-Behavioral	Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
OG001	Standard Care	Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].

Units	Counts
Participants

Secondary

MHQ Physical Limitations at End of Treatment

Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.

All subjects completing end of treatment home visit with research assistant.

Posted

Mean

Standard Deviation

units on a scale

End of Treatment (Week 6)

ID	Title	Description
OG000	Educational-Medical-Behavioral	Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
OG001	Standard Care	Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].

Units	Counts
Participants

Secondary

MHQ Physical Limitations at Follow Up

Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.

All subjects completing end of treatment home visit with research assistant.

Posted

Mean

Standard Deviation

units on a scale

6 months after (6-Week) treatment ends

ID	Title	Description
OG000	Educational-Medical-Behavioral	Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
OG001	Standard Care	Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].

Units	Counts
Participants

Secondary

MHQ Social Limitations at End of Treatment

Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.

All subjects completing end of treatment home visit with research assistant.

Posted

Mean

Standard Deviation

units on a scale

End of Treatment (Week 6)

ID	Title	Description
OG000	Educational-Medical-Behavioral	Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
OG001	Standard Care	Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].

Units	Counts
Participants

Secondary

MHQ Social Limitations at Follow Up

Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.

All subjects completing end of treatment home visit with research assistant.

Posted

Mean

Standard Deviation

units on a scale

6 months after (6-Week) treatment ends

ID	Title	Description
OG000	Educational-Medical-Behavioral	Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
OG001	Standard Care	Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].

Units	Counts
Participants

Secondary

MHQ Personal Relationships at End of Treatment

Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.

All subjects completing end of treatment home visit with research assistant.

Posted

Mean

Standard Deviation

units on a scale

End of Treatment (Week 6)

ID	Title	Description
OG000	Educational-Medical-Behavioral	Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
OG001	Standard Care	Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].

Units	Counts
Participants

Secondary

MHQ Personal Relationships at Follow Up

Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.

All subjects completing end of treatment home visit with research assistant.

Posted

Mean

Standard Deviation

units on a scale

6 months after (6-Week) treatment ends

ID	Title	Description
OG000	Educational-Medical-Behavioral	Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
OG001	Standard Care	Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].

Units	Counts
Participants

Secondary

MHQ Emotions at End of Treatment

Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.

All subjects completing end of treatment home visit with research assistant.

Posted

Mean

Standard Deviation

units on a scale

End of Treatment (Week 6)

ID	Title	Description
OG000	Educational-Medical-Behavioral	Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
OG001	Standard Care	Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].

Units	Counts
Participants

Secondary

MHQ Emotions at Follow Up

Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.

All subjects completing end of treatment home visit with research assistant.

Posted

Mean

Standard Deviation

units on a scale

6 months after (6-Week) treatment ends

ID	Title	Description
OG000	Educational-Medical-Behavioral	Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
OG001	Standard Care	Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].

Units	Counts
Participants

Secondary

MHQ Sleep Energy at End of Treatment

Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.

All subjects completing end of treatment home visit with research assistant.

Posted

Mean

Standard Deviation

units on a scale

End of Treatment (Week 6)

ID	Title	Description
OG000	Educational-Medical-Behavioral	Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
OG001	Standard Care	Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].

Units	Counts
Participants

Secondary

MHQ Sleep Energy at Follow Up

Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.

All subjects completing end of treatment home visit with research assistant.

Posted

Mean

Standard Deviation

units on a scale

6 months after (6-Week) treatment ends

ID	Title	Description
OG000	Educational-Medical-Behavioral	Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
OG001	Standard Care	Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].

Units	Counts
Participants

Other Pre-specified

Cognitive Status at End of Treatment

OASIS question M1700: Cognitive functioning: Patient's current (day of assessment) level of alertness, orientation, comprehension, concentration, and immediate memory for simple commands. Measure as treatment moderator. Response categories are:

0 - Alert/oriented, able to focus and shift attention, comprehends and recalls task directions independently.

- Requires prompting (cuing, repetition, reminders) only under stressful or unfamiliar conditions.
- Requires assistance and some direction in specific situations (e.g., on all tasks involving shifting of attention), or consistently requires low stimulus environment due to distractibility.
- Requires considerable assistance in routine situations. Is not alert and oriented or is unable to shift attention and recall directions more than half the time.
- Totally dependent due to disturbances uch as constant disorientation, coma, persistent vegetative stte, or delirium.

Analysis population is all patients who provided data on this measure at end of treatment. Data were missing for 2/11 in Group A and 6/8 in Group B.

Posted

Median

Full Range

units on a scale

End of Treatment (Week 6)

ID	Title	Description
OG000	Educational-Medical-Behavioral	Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].

Other Pre-specified

Change in Ambulation From Baseline to End of Treatment

OASIS question M1860: Ambulation/locomotion: Current ability to walk safely, once in a standing position, or use a wheelchair, once in a seated position, on a variety of surfaces. Measure as a moderator of treatment effects. Responses:

0. Able to independently walk on even and uneven surfaces and negotiate stairs with or without railings (i.e., needs no human assistance or assistive device).

Requires use of a device (e.g., cane, walker) to walk alone or requires human supervision or assistance to negotiate stairs or steps or uneven surfaces.
Able to walk only with the supervision or assistance of another person at all times.
Chairfast, unable to ambulate but is able to wheel self independently.
Chairfast, unable to ambulate and is unable to wheel self.
Bedfast, unable to ambulate or be up in a chair.

Higher scores represent improvement in ability to ambulate.

Analysis sample consists of all patients who provided data for this questionnaire at the end of treatment. Two EMB subjects did not provide this data for unknown reasons, and 4 SC subjects did not provide this data for unknown reasons.

Posted

Median

Full Range

units on a scale

Baseline, End of Treatment (Week 6)

ID	Title	Description
OG000	Educational-Medical-Behavioral	Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].

Other Pre-specified

Ability to Reach Toilet at End of Treatment

OASIS question M1840: Toilet transferring: Current ability to get to and from the toilet or bedside commode safely and transfer on and off toilet/commode. Measure as moderator of treatment outcomes.

A lower score is better.

Responses:

0. Able to get to and from the toilet and transfer independently with or without a device.

When reminded, assisted, or supervised by another person, able to get to and from the toilet.
Unable to get to and from the toilet but is able to use a bedside commode (with or without assistance).
Unable to get to and from the toilet or bedside commode but is able to use a bedpan/urinal independently.
Is totally dependent in toileting.

All patients who provided data for this measure at the end of treatment.

Posted

Median

Full Range

units on a scale

End of Treatment (Week 6)

ID	Title	Description
OG000	Educational-Medical-Behavioral	Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
OG001	Standard Care	Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].

Other Pre-specified

When is Patient Anxious at End of Treatment?

OASIS question M1720: When anxious (reported or observed within the last 14 days). Measured as moderator of treatment effects on ordinal scale. Higher scores indicate a greater level of anxiousness. Responses are:

0 - None of the time

- Less often than daily
- Daily, but not constantly
- All of the time

Analysis population consists of all patients who provided end of treatment data.

Posted

Median

Full Range

units on a scale

End of Treatment (Week 6)

ID	Title	Description
OG000	Educational-Medical-Behavioral	Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
OG001	Standard Care	Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].

Units	Counts

Other Pre-specified

Depression Screening at End of Treatment

OASIS question M1730: Depression Screening. Measure as a moderator of treatment effectiveness on categorical scale. Possible responses are:

0= No screening

Screened for depression with PHQ2 measure
Screened with PHQ2 and meets criteria for further evaluation of depression
Screened and does not meet criteria for further evaluation of depression

Analysis population consists of all patients providing data at end of treatment.

Posted

Number

participants

End of Treatment (Week 6)

ID	Title	Description
OG000	Educational-Medical-Behavioral	Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
OG001	Standard Care	Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].

Units	Counts

Other Pre-specified

Patient's Living Situation at End of Treatment

OASIS question M1100: Patient living situation: This is a measure that combines who lives with the patient and the frequency that assistance is available to them throughout the day. Responses are coded on a 1-15 scale. Measure this as a moderator of treatment effectiveness.

Analysis population consists of all patients who provided data at end of treatment

Posted

Number

participants

End of Treatment (Week 6)

ID	Title	Description
OG000	Educational-Medical-Behavioral	Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
OG001	Standard Care	Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].

Units	Counts
Participants

Other Pre-specified

Caregiver's Ability and Willingness to Assist With ADLs at End of Treatment

OASIS question M2100, item A: Types and sources of assistance for ADLs. Measure as moderator of treatment effectiveness. Responses range from "No assistance needed in this area" to "Assistance needed, but no Caregivers available". Ordinal scale with 6 levels:

0= No assistance needed

Caregiver provides assistance
Caregiver needs training or support
Caregiver is unlikely to provide assistance
Unclear if caregiver will assist patient
Assistance is needed but is not available

Analysis population consists of all patients who provided data at end of treatment

Posted

Median

Full Range

units on a scale

End of Treatment (Week 6)

ID	Title	Description
OG000	Educational-Medical-Behavioral	Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
OG001	Standard Care	Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Educational-Medical-Behavioral	Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [Mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].			0	11	0	11
EG001	Standard Care	Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].			1	8	0	8

ID	Term
D012002	Rectal Diseases
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

ID	Term
D004522	Educational Status
D054368	Laxatives
D008139	Loperamide
C000595212	polyethylene glycol 3350
D011092	Polyethylene Glycols
D003020	Clothing

ID	Term
D012959	Socioeconomic Factors
D011154	Population Characteristics
D005765	Gastrointestinal Agents
D045506	Therapeutic Uses
D020228	Pharmacologic Actions
D020164	Chemical Actions and Uses
D010880	Piperidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D005026	Ethylene Glycols
D006018	Glycols
D000438	Alcohols
D009930	Organic Chemicals
D011108	Polymers
D046911	Macromolecular Substances
D001697	Biomedical and Dental Materials
D008420	Manufactured Materials
D013676	Technology, Industry, and Agriculture

ID	Title	Description
BG000	Educational-Medical-Behavioral	Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
BG001	Standard Care	Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
BG002	Total	Total of all reporting groups