Trial Outcomes & Findings for Educational-Medical-Behavioral Treatment of Fecal Incontinence (NCT NCT01717456)
NCT ID: NCT01717456
Last Updated: 2017-02-17
Results Overview
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.
TERMINATED
NA
31 participants
End of Treatment (Week 6)
2017-02-17
Participant Flow
Home Health Care (HHC) provided lists to the investigators of new patients who were screened by HHC using the OASIS Questionnaire. Research assistants identified eligible patients based on the OASIS questions and telephoned them to obtain verbal consent and to schedule a baseline assessment visit. Written consent was obtained at the baseline visit.
Baseline data collection and written consent was obtained at a home visit prior to referring the patient to HHC for randomization and initiation of treatment. Only 19/31 who gave consent to the research assistant were randomized. 3 others were judged ineligible by HHC, and 9 dropped out while awaiting treatment.
Participant milestones
| Measure |
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 \[as needed\].
|
Standard Care
Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day\], daily diary, and protective pads or garments \[as needed\].
|
|---|---|---|
|
End of Treatment
STARTED
|
11
|
8
|
|
End of Treatment
COMPLETED
|
11
|
6
|
|
End of Treatment
NOT COMPLETED
|
0
|
2
|
|
Follow-Up 6 Months After End of Tx
STARTED
|
11
|
6
|
|
Follow-Up 6 Months After End of Tx
COMPLETED
|
7
|
2
|
|
Follow-Up 6 Months After End of Tx
NOT COMPLETED
|
4
|
4
|
Reasons for withdrawal
| Measure |
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 \[as needed\].
|
Standard Care
Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day\], daily diary, and protective pads or garments \[as needed\].
|
|---|---|---|
|
End of Treatment
Physician Decision
|
0
|
1
|
|
End of Treatment
Lost to Follow-up
|
0
|
1
|
|
Follow-Up 6 Months After End of Tx
Lost to Follow-up
|
4
|
4
|
Baseline Characteristics
Data were missing for 2/11 in Group A and 6/8 in Group B.
Baseline characteristics by cohort
| Measure |
Educational-Medical-Behavioral
n=11 Participants
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 \[if needed\].
|
Standard Care
n=8 Participants
Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day\], daily diary, and protective pads or garments \[as needed\].
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
86.11 years
STANDARD_DEVIATION 4.51 • n=11 Participants
|
85.00 years
STANDARD_DEVIATION 3.61 • n=8 Participants
|
85.83 years
STANDARD_DEVIATION 4.17 • n=19 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=11 Participants
|
5 Participants
n=8 Participants
|
16 Participants
n=19 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=11 Participants
|
3 Participants
n=8 Participants
|
3 Participants
n=19 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=11 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=19 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=11 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=19 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=11 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=19 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=11 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=19 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=11 Participants
|
3 Participants
n=8 Participants
|
13 Participants
n=19 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=11 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=19 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=11 Participants
|
5 Participants
n=8 Participants
|
5 Participants
n=19 Participants
|
|
Fecal Incontinence Severity Index (FISI) at Baseline
|
24.50 units on a scale
STANDARD_DEVIATION 12.22 • n=11 Participants
|
22.75 units on a scale
STANDARD_DEVIATION 8.14 • n=8 Participants
|
23.72 units on a scale
STANDARD_DEVIATION 2.44 • n=19 Participants
|
|
Manchester Health Questionnaire (MHQ) Severity Scale at Baseline
|
48.64 units on a scale
STANDARD_DEVIATION 17.76 • n=11 Participants
|
50.00 units on a scale
STANDARD_DEVIATION 18.13 • n=8 Participants
|
49.21 units on a scale
STANDARD_DEVIATION 17.42 • n=19 Participants
|
|
MHQ Incontinence Impact at Baseline
|
52.27 units on a scale
STANDARD_DEVIATION 23.60 • n=11 Participants
|
65.63 units on a scale
STANDARD_DEVIATION 26.52 • n=8 Participants
|
57.89 units on a scale
STANDARD_DEVIATION 25.07 • n=19 Participants
|
|
MHQ Role Limitations at Baseline
|
13.64 units on a scale
STANDARD_DEVIATION 26.49 • n=11 Participants
|
50.00 units on a scale
STANDARD_DEVIATION 29.12 • n=8 Participants
|
28.95 units on a scale
STANDARD_DEVIATION 32.56 • n=19 Participants
|
|
MHQ Physical Limitations at Baseline
|
18.18 units on a scale
STANDARD_DEVIATION 21.91 • n=11 Participants
|
50.00 units on a scale
STANDARD_DEVIATION 28.35 • n=8 Participants
|
31.58 units on a scale
STANDARD_DEVIATION 28.98 • n=19 Participants
|
|
MHQ Social Limitations at Baseline
|
16.67 units on a scale
STANDARD_DEVIATION 29.11 • n=11 Participants
|
43.75 units on a scale
STANDARD_DEVIATION 35.57 • n=8 Participants
|
28.07 units on a scale
STANDARD_DEVIATION 33.93 • n=19 Participants
|
|
MHQ Personal Relationships at Baseline
|
8.33 units on a scale
STANDARD_DEVIATION 20.41 • n=11 Participants
|
20.00 units on a scale
STANDARD_DEVIATION 32.60 • n=8 Participants
|
13.64 units on a scale
STANDARD_DEVIATION 25.89 • n=19 Participants
|
|
MHQ Emotions at Baseline
|
19.70 units on a scale
STANDARD_DEVIATION 15.49 • n=11 Participants
|
51.04 units on a scale
STANDARD_DEVIATION 28.67 • n=8 Participants
|
32.89 units on a scale
STANDARD_DEVIATION 26.57 • n=19 Participants
|
|
MHQ Sleep Energy at Baseline
|
7.95 units on a scale
STANDARD_DEVIATION 14.00 • n=11 Participants
|
23.44 units on a scale
STANDARD_DEVIATION 28.69 • n=8 Participants
|
14.47 units on a scale
STANDARD_DEVIATION 22.15 • n=19 Participants
|
|
Zarit Caregiver Burden Scale at Baseline
|
36.00 units on a scale
STANDARD_DEVIATION 42.43 • n=11 Participants
|
18.33 units on a scale
STANDARD_DEVIATION 13.50 • n=8 Participants
|
22.75 units on a scale
STANDARD_DEVIATION 14.13 • n=19 Participants
|
|
Frequency of fecal incontinence at Baseline
|
2 units on a scale
n=9 Participants • Data were missing for 2/11 in Group A and 6/8 in Group B.
|
4.5 units on a scale
n=2 Participants • Data were missing for 2/11 in Group A and 6/8 in Group B.
|
2 units on a scale
n=11 Participants • Data were missing for 2/11 in Group A and 6/8 in Group B.
|
|
Urinary Continence Status at Baseline
|
1 units on a scale
n=9 Participants • Data were missing for 2/11 in Group A and 6/8 for Group B.
|
0.5 units on a scale
n=2 Participants • Data were missing for 2/11 in Group A and 6/8 for Group B.
|
1 units on a scale
n=11 Participants • Data were missing for 2/11 in Group A and 6/8 for Group B.
|
|
Cognitive Function at Baseline
|
0 units on a scale
n=9 Participants • Data were missing for 2/11 in Group A and 6/8 for Group B.
|
0 units on a scale
n=2 Participants • Data were missing for 2/11 in Group A and 6/8 for Group B.
|
0 units on a scale
n=11 Participants • Data were missing for 2/11 in Group A and 6/8 for Group B.
|
|
Ambulation at Baseline
|
0 units on a scale
n=11 Participants
|
0.5 units on a scale
n=8 Participants
|
0.2 units on a scale
n=19 Participants
|
|
Ability to use toilet at Baseline
|
0 participants
n=9 Participants • Data were missing for 2/11 in Group A and 6/8 for Group B.
|
0 participants
n=2 Participants • Data were missing for 2/11 in Group A and 6/8 for Group B.
|
0 participants
n=11 Participants • Data were missing for 2/11 in Group A and 6/8 for Group B.
|
|
When is patient anxious at Baseline?
|
0 units on a scale
n=11 Participants
|
0 units on a scale
n=8 Participants
|
0 units on a scale
n=19 Participants
|
|
Depression Screening at Baseline
Not screened for depression
|
8 participants
n=11 Participants
|
1 participants
n=8 Participants
|
9 participants
n=19 Participants
|
|
Depression Screening at Baseline
Screened by Patient Health Questionnaire 2 (PHQ2)
|
1 participants
n=11 Participants
|
1 participants
n=8 Participants
|
2 participants
n=19 Participants
|
|
Depression Screening at Baseline
Requires further evaluation
|
0 participants
n=11 Participants
|
0 participants
n=8 Participants
|
0 participants
n=19 Participants
|
|
Depression Screening at Baseline
Screened and does not need further evaluation
|
0 participants
n=11 Participants
|
0 participants
n=8 Participants
|
0 participants
n=19 Participants
|
|
Depression Screening at Baseline
Unknown
|
2 participants
n=11 Participants
|
6 participants
n=8 Participants
|
8 participants
n=19 Participants
|
|
Living Situation at Baseline
Lives alone
|
3 participants
n=11 Participants
|
0 participants
n=8 Participants
|
3 participants
n=19 Participants
|
|
Living Situation at Baseline
Lives with another adult
|
4 participants
n=11 Participants
|
2 participants
n=8 Participants
|
6 participants
n=19 Participants
|
|
Living Situation at Baseline
Lives in assisted living
|
2 participants
n=11 Participants
|
0 participants
n=8 Participants
|
2 participants
n=19 Participants
|
|
Living Situation at Baseline
Unknown
|
2 participants
n=11 Participants
|
6 participants
n=8 Participants
|
8 participants
n=19 Participants
|
|
Source of Assistance with ADLs at Baseline
No assistance needed
|
5 participants
n=11 Participants
|
2 participants
n=8 Participants
|
7 participants
n=19 Participants
|
|
Source of Assistance with ADLs at Baseline
Caregiver provides assistance
|
3 participants
n=11 Participants
|
0 participants
n=8 Participants
|
3 participants
n=19 Participants
|
|
Source of Assistance with ADLs at Baseline
Caregiver needs training or support
|
0 participants
n=11 Participants
|
0 participants
n=8 Participants
|
0 participants
n=19 Participants
|
|
Source of Assistance with ADLs at Baseline
Caregiver unlikely to provide assistance
|
0 participants
n=11 Participants
|
0 participants
n=8 Participants
|
0 participants
n=19 Participants
|
|
Source of Assistance with ADLs at Baseline
Unclear if caregiver will assist patient
|
0 participants
n=11 Participants
|
0 participants
n=8 Participants
|
0 participants
n=19 Participants
|
|
Source of Assistance with ADLs at Baseline
Assistance needed but not available
|
0 participants
n=11 Participants
|
0 participants
n=8 Participants
|
0 participants
n=19 Participants
|
|
Source of Assistance with ADLs at Baseline
Unknown
|
3 participants
n=11 Participants
|
6 participants
n=8 Participants
|
9 participants
n=19 Participants
|
PRIMARY outcome
Timeframe: End of Treatment (Week 6)Population: 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.
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.
Outcome measures
| Measure |
Standard Care
n=5 Participants
Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day\], daily diary, and protective pads or garments \[as needed\].
|
Educational-Medical-Behavioral
n=10 Participants
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 \[if needed\].
|
|---|---|---|
|
Fecal Incontinence Severity Index (FISI) at End of Treatment
|
22.00 units on a scale
Standard Deviation 9.17
|
18.00 units on a scale
Standard Deviation 10.30
|
PRIMARY outcome
Timeframe: 6 months after (6-Week) treatment endsPopulation: The analysis sample consists of all patients who provided data at the 6 month FU visit.
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.
Outcome measures
| Measure |
Standard Care
n=2 Participants
Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day\], daily diary, and protective pads or garments \[as needed\].
|
Educational-Medical-Behavioral
n=7 Participants
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 \[if needed\].
|
|---|---|---|
|
Fecal Incontinence Severity Index (FISI) at Follow-Up (FU)
|
37.00 units on a scale
Standard Deviation 21.21
|
14.86 units on a scale
Standard Deviation 12.71
|
SECONDARY outcome
Timeframe: End of Treatment (Week 6)Population: Data not available for 1/11 Educational-Medical-Behavioral group subject and for 2/8 Standard Care subjects.
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.
Outcome measures
| Measure |
Standard Care
n=6 Participants
Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day\], daily diary, and protective pads or garments \[as needed\].
|
Educational-Medical-Behavioral
n=10 Participants
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 \[if needed\].
|
|---|---|---|
|
Adequate Relief of Fecal Incontinence at End of Treatment
Yes, Adequate Relief
|
1 participants
|
5 participants
|
|
Adequate Relief of Fecal Incontinence at End of Treatment
No, No Adequate Relief
|
3 participants
|
5 participants
|
|
Adequate Relief of Fecal Incontinence at End of Treatment
Unknown
|
2 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 6 months after (6-Week) treatment endsPopulation: Data not available for 3/7 Educational-Medical-Behavioral group subject and for 2/2 Standard Care subjects.
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.
Outcome measures
| Measure |
Standard Care
n=2 Participants
Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day\], daily diary, and protective pads or garments \[as needed\].
|
Educational-Medical-Behavioral
n=7 Participants
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 \[if needed\].
|
|---|---|---|
|
Adequate Relief of Fecal Incontinence at Follow Up
Yes, Adequate Relief
|
0 participants
|
1 participants
|
|
Adequate Relief of Fecal Incontinence at Follow Up
No, no Adequate Relief
|
0 participants
|
3 participants
|
|
Adequate Relief of Fecal Incontinence at Follow Up
Unknown
|
2 participants
|
3 participants
|
SECONDARY outcome
Timeframe: End of Treatment (Week 6)Population: All subjects completing end of treatment home visit with research assistant.
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.
Outcome measures
| Measure |
Standard Care
n=8 Participants
Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day\], daily diary, and protective pads or garments \[as needed\].
|
Educational-Medical-Behavioral
n=11 Participants
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 \[if needed\].
|
|---|---|---|
|
MHQ Severity Scale at End of Treatment
|
55.00 units on a scale
Standard Deviation 23.72
|
42.50 units on a scale
Standard Deviation 28.41
|
SECONDARY outcome
Timeframe: 6 months after (6-Week) treatment endsPopulation: All subjects completing end of treatment home visit with research assistant.
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.
Outcome measures
| Measure |
Standard Care
n=2 Participants
Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day\], daily diary, and protective pads or garments \[as needed\].
|
Educational-Medical-Behavioral
n=7 Participants
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 \[if needed\].
|
|---|---|---|
|
MHQ Severity Scale at Follow Up
|
47.50 units on a scale
Standard Deviation 31.82
|
39.29 units on a scale
Standard Deviation 25.40
|
SECONDARY outcome
Timeframe: End of Treatment (Week 6)Population: Family caregivers of patients completing the study. Some caregivers declined or no caregiver was available.
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.
Outcome measures
| Measure |
Standard Care
n=2 Participants
Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day\], daily diary, and protective pads or garments \[as needed\].
|
Educational-Medical-Behavioral
n=2 Participants
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 \[if needed\].
|
|---|---|---|
|
Zarit Caregiver Burden Scale at End of Treatment
|
30.50 units on a scale
Standard Deviation 23.34
|
33.00 units on a scale
Standard Deviation 42.43
|
SECONDARY outcome
Timeframe: 6 months after (6-Week) treatment endsPopulation: Family caregivers of patients completing the study. Some caregivers declined or no caregiver was available.
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.
Outcome measures
| Measure |
Standard Care
n=2 Participants
Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day\], daily diary, and protective pads or garments \[as needed\].
|
Educational-Medical-Behavioral
n=7 Participants
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 \[if needed\].
|
|---|---|---|
|
Zarit Caregiver Burden Scale at Follow Up
|
25.50 units on a scale
Standard Deviation 20.51
|
14.00 units on a scale
Standard Deviation 14.00
|
SECONDARY outcome
Timeframe: End of Treatment (Week 6)Population: 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.
OASIS question M1620: Bowel incontinence frequency. Response options are: 0 - Very rarely or never has bowel incontinence 1. \- Less than once weekly 2. \- One to three times weekly 3. \- Four to six times weekly 4. \- On a daily basis 5. \- More often than once daily
Outcome measures
| Measure |
Standard Care
n=2 Participants
Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day\], daily diary, and protective pads or garments \[as needed\].
|
Educational-Medical-Behavioral
n=9 Participants
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 \[if needed\].
|
|---|---|---|
|
Fecal Incontinence Frequency at End of Treatment
|
2 units on a scale
Interval 0.0 to 4.0
|
1 units on a scale
Interval 0.0 to 3.0
|
SECONDARY outcome
Timeframe: Baseline, end of treatment (week 6)Population: 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.
OASIS question M1610: Urinary incontinence or urinary catheter presence. Response options are: 0 - No incontinence or catheter (includes anuria or ostomy for urinary drainage) 1. \- Patient is incontinent 2. \- Patient requires a urinary catheter (i.e., external, indwelling, intermittent, suprapubic)
Outcome measures
| Measure |
Standard Care
n=2 Participants
Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day\], daily diary, and protective pads or garments \[as needed\].
|
Educational-Medical-Behavioral
n=9 Participants
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 \[if needed\].
|
|---|---|---|
|
Urinary Incontinence Status Change From Baseline to End of Treatment
|
0.50 units on a scale
Interval 0.0 to 1.0
|
1 units on a scale
Interval 0.0 to 1.0
|
SECONDARY outcome
Timeframe: End of Treatment (Week 6)Population: Analysis sample was all patients who provided data 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.
Outcome measures
| Measure |
Standard Care
n=2 Participants
Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day\], daily diary, and protective pads or garments \[as needed\].
|
Educational-Medical-Behavioral
n=8 Participants
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 \[if needed\].
|
|---|---|---|
|
Admission to Nursing Home at End of Treatment
Admitted to nursing home
|
0 participants
|
0 participants
|
|
Admission to Nursing Home at End of Treatment
Not admitted to nursing home
|
2 participants
|
8 participants
|
SECONDARY outcome
Timeframe: End of Treatment (Week 6)Population: All subjects completing end of treatment home visit with research assistant.
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.
Outcome measures
| Measure |
Standard Care
n=5 Participants
Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day\], daily diary, and protective pads or garments \[as needed\].
|
Educational-Medical-Behavioral
n=10 Participants
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 \[if needed\].
|
|---|---|---|
|
MHQ Incontinence Impact at End of Treatment
|
70.00 units on a scale
Standard Deviation 20.92
|
42.50 units on a scale
Standard Deviation 23.72
|
SECONDARY outcome
Timeframe: 6 months after (6-Week) treatment endsPopulation: All subjects completing end of treatment home visit with research assistant.
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.
Outcome measures
| Measure |
Standard Care
n=2 Participants
Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day\], daily diary, and protective pads or garments \[as needed\].
|
Educational-Medical-Behavioral
n=7 Participants
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 \[if needed\].
|
|---|---|---|
|
MHQ Incontinence Impact at Follow Up
|
25.00 units on a scale
Standard Deviation 0.00
|
35.71 units on a scale
Standard Deviation 24.40
|
SECONDARY outcome
Timeframe: End of Treatment (Week 6)Population: All subjects completing end of treatment home visit with research assistant.
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.
Outcome measures
| Measure |
Standard Care
n=8 Participants
Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day\], daily diary, and protective pads or garments \[as needed\].
|
Educational-Medical-Behavioral
n=11 Participants
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 \[if needed\].
|
|---|---|---|
|
MHQ Role Limitations at End of Treatment
|
57.50 units on a scale
Standard Deviation 34.91
|
16.25 units on a scale
Standard Deviation 28.90
|
SECONDARY outcome
Timeframe: 6 months after (6-Week) treatment endsPopulation: All subjects completing end of treatment home visit with research assistant.
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.
Outcome measures
| Measure |
Standard Care
n=2 Participants
Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day\], daily diary, and protective pads or garments \[as needed\].
|
Educational-Medical-Behavioral
n=7 Participants
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 \[if needed\].
|
|---|---|---|
|
MHQ Role Limitations at Follow Up
|
12.50 units on a scale
Standard Deviation 17.68
|
14.29 units on a scale
Standard Deviation 19.67
|
SECONDARY outcome
Timeframe: End of Treatment (Week 6)Population: All subjects completing end of treatment home visit with research assistant.
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.
Outcome measures
| Measure |
Standard Care
n=8 Participants
Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day\], daily diary, and protective pads or garments \[as needed\].
|
Educational-Medical-Behavioral
n=11 Participants
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 \[if needed\].
|
|---|---|---|
|
MHQ Physical Limitations at End of Treatment
|
60.00 units on a scale
Standard Deviation 32.36
|
18.75 units on a scale
Standard Deviation 31.87
|
SECONDARY outcome
Timeframe: 6 months after (6-Week) treatment endsPopulation: All subjects completing end of treatment home visit with research assistant.
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.
Outcome measures
| Measure |
Standard Care
n=2 Participants
Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day\], daily diary, and protective pads or garments \[as needed\].
|
Educational-Medical-Behavioral
n=7 Participants
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 \[if needed\].
|
|---|---|---|
|
MHQ Physical Limitations at Follow Up
|
31.25 units on a scale
Standard Deviation 8.84
|
7.14 units on a scale
Standard Deviation 18.90
|
SECONDARY outcome
Timeframe: End of Treatment (Week 6)Population: All subjects completing end of treatment home visit with research assistant.
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.
Outcome measures
| Measure |
Standard Care
n=8 Participants
Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day\], daily diary, and protective pads or garments \[as needed\].
|
Educational-Medical-Behavioral
n=11 Participants
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 \[if needed\].
|
|---|---|---|
|
MHQ Social Limitations at End of Treatment
|
48.33 units on a scale
Standard Deviation 43.46
|
15.83 units on a scale
Standard Deviation 26.77
|
SECONDARY outcome
Timeframe: 6 months after (6-Week) treatment endsPopulation: All subjects completing end of treatment home visit with research assistant.
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.
Outcome measures
| Measure |
Standard Care
n=2 Participants
Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day\], daily diary, and protective pads or garments \[as needed\].
|
Educational-Medical-Behavioral
n=7 Participants
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 \[if needed\].
|
|---|---|---|
|
MHQ Social Limitations at Follow Up
|
4.17 units on a scale
Standard Deviation 5.89
|
2.38 units on a scale
Standard Deviation 6.30
|
SECONDARY outcome
Timeframe: End of Treatment (Week 6)Population: All subjects completing end of treatment home visit with research assistant.
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.
Outcome measures
| Measure |
Standard Care
n=6 Participants
Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day\], daily diary, and protective pads or garments \[as needed\].
|
Educational-Medical-Behavioral
n=11 Participants
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 \[if needed\].
|
|---|---|---|
|
MHQ Personal Relationships at End of Treatment
|
25.00 units on a scale
Standard Deviation 35.36
|
0 units on a scale
Standard Deviation 0
|
SECONDARY outcome
Timeframe: 6 months after (6-Week) treatment endsPopulation: All subjects completing end of treatment home visit with research assistant.
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.
Outcome measures
| Measure |
Standard Care
n=2 Participants
Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day\], daily diary, and protective pads or garments \[as needed\].
|
Educational-Medical-Behavioral
n=7 Participants
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 \[if needed\].
|
|---|---|---|
|
MHQ Personal Relationships at Follow Up
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0
|
SECONDARY outcome
Timeframe: End of Treatment (Week 6)Population: All subjects completing end of treatment home visit with research assistant.
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.
Outcome measures
| Measure |
Standard Care
n=8 Participants
Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day\], daily diary, and protective pads or garments \[as needed\].
|
Educational-Medical-Behavioral
n=11 Participants
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 \[if needed\].
|
|---|---|---|
|
MHQ Emotions at End of Treatment
|
50.00 units on a scale
Standard Deviation 38.64
|
24.17 units on a scale
Standard Deviation 29.52
|
SECONDARY outcome
Timeframe: 6 months after (6-Week) treatment endsPopulation: All subjects completing end of treatment home visit with research assistant.
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.
Outcome measures
| Measure |
Standard Care
n=2 Participants
Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day\], daily diary, and protective pads or garments \[as needed\].
|
Educational-Medical-Behavioral
n=7 Participants
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 \[if needed\].
|
|---|---|---|
|
MHQ Emotions at Follow Up
|
12.50 units on a scale
Standard Deviation 5.89
|
13.10 units on a scale
Standard Deviation 13.49
|
SECONDARY outcome
Timeframe: End of Treatment (Week 6)Population: All subjects completing end of treatment home visit with research assistant.
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.
Outcome measures
| Measure |
Standard Care
n=8 Participants
Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day\], daily diary, and protective pads or garments \[as needed\].
|
Educational-Medical-Behavioral
n=11 Participants
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 \[if needed\].
|
|---|---|---|
|
MHQ Sleep Energy at End of Treatment
|
32.50 units on a scale
Standard Deviation 20.92
|
10.00 units on a scale
Standard Deviation 17.48
|
SECONDARY outcome
Timeframe: 6 months after (6-Week) treatment endsPopulation: All subjects completing end of treatment home visit with research assistant.
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.
Outcome measures
| Measure |
Standard Care
n=2 Participants
Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day\], daily diary, and protective pads or garments \[as needed\].
|
Educational-Medical-Behavioral
n=7 Participants
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 \[if needed\].
|
|---|---|---|
|
MHQ Sleep Energy at Follow Up
|
0 units on a scale
Standard Deviation 0
|
3.57 units on a scale
Standard Deviation 6.10
|
OTHER_PRE_SPECIFIED outcome
Timeframe: End of Treatment (Week 6)Population: 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.
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. 1. \- Requires prompting (cuing, repetition, reminders) only under stressful or unfamiliar conditions. 2. \- 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. 3. \- 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. 4. \- Totally dependent due to disturbances uch as constant disorientation, coma, persistent vegetative stte, or delirium.
Outcome measures
| Measure |
Standard Care
n=2 Participants
Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day\], daily diary, and protective pads or garments \[as needed\].
|
Educational-Medical-Behavioral
n=9 Participants
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 \[if needed\].
|
|---|---|---|
|
Cognitive Status at End of Treatment
|
0 units on a scale
Interval 0.0 to 0.0
|
0 units on a scale
Interval 0.0 to 1.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, End of Treatment (Week 6)Population: 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.
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). 1. 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. 2. Able to walk only with the supervision or assistance of another person at all times. 3. Chairfast, unable to ambulate but is able to wheel self independently. 4. Chairfast, unable to ambulate and is unable to wheel self. 5. Bedfast, unable to ambulate or be up in a chair. Higher scores represent improvement in ability to ambulate.
Outcome measures
| Measure |
Standard Care
n=2 Participants
Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day\], daily diary, and protective pads or garments \[as needed\].
|
Educational-Medical-Behavioral
n=9 Participants
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 \[if needed\].
|
|---|---|---|
|
Change in Ambulation From Baseline to End of Treatment
|
0 units on a scale
Interval 0.0 to 0.0
|
0 units on a scale
Interval 0.0 to 2.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: End of Treatment (Week 6)Population: All patients who provided data for this measure at the 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. 1. When reminded, assisted, or supervised by another person, able to get to and from the toilet. 2. Unable to get to and from the toilet but is able to use a bedside commode (with or without assistance). 3. Unable to get to and from the toilet or bedside commode but is able to use a bedpan/urinal independently. 4. Is totally dependent in toileting.
Outcome measures
| Measure |
Standard Care
n=2 Participants
Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day\], daily diary, and protective pads or garments \[as needed\].
|
Educational-Medical-Behavioral
n=9 Participants
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 \[if needed\].
|
|---|---|---|
|
Ability to Reach Toilet at End of Treatment
|
0 units on a scale
Interval 0.0 to 0.0
|
0 units on a scale
Interval 0.0 to 0.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: End of Treatment (Week 6)Population: Analysis population consists of all patients who provided end of treatment data.
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 1. \- Less often than daily 2. \- Daily, but not constantly 3. \- All of the time
Outcome measures
| Measure |
Standard Care
n=2 Participants
Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day\], daily diary, and protective pads or garments \[as needed\].
|
Educational-Medical-Behavioral
n=9 Participants
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 \[if needed\].
|
|---|---|---|
|
When is Patient Anxious at End of Treatment?
|
0 units on a scale
Interval 0.0 to 0.0
|
0 units on a scale
Interval 0.0 to 0.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: End of Treatment (Week 6)Population: Analysis population consists of all patients providing data 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 1. Screened for depression with PHQ2 measure 2. Screened with PHQ2 and meets criteria for further evaluation of depression 3. Screened and does not meet criteria for further evaluation of depression
Outcome measures
| Measure |
Standard Care
n=2 Participants
Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day\], daily diary, and protective pads or garments \[as needed\].
|
Educational-Medical-Behavioral
n=9 Participants
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 \[if needed\].
|
|---|---|---|
|
Depression Screening at End of Treatment
No screening
|
2 participants
|
7 participants
|
|
Depression Screening at End of Treatment
Screened by PHQ2
|
0 participants
|
2 participants
|
|
Depression Screening at End of Treatment
Meets criteria for further evaluation of depressio
|
0 participants
|
0 participants
|
|
Depression Screening at End of Treatment
Does not meet criteria for further evaluation
|
0 participants
|
0 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: End of Treatment (Week 6)Population: Analysis population consists of all patients who provided data 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.
Outcome measures
| Measure |
Standard Care
n=2 Participants
Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day\], daily diary, and protective pads or garments \[as needed\].
|
Educational-Medical-Behavioral
n=9 Participants
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 \[if needed\].
|
|---|---|---|
|
Patient's Living Situation at End of Treatment
Lives alone
|
0 participants
|
3 participants
|
|
Patient's Living Situation at End of Treatment
Lives with another adult
|
2 participants
|
3 participants
|
|
Patient's Living Situation at End of Treatment
Lives in assisted living
|
0 participants
|
3 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: End of Treatment (Week 6)Population: Analysis population consists of all patients who provided data 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 1. Caregiver provides assistance 2. Caregiver needs training or support 3. Caregiver is unlikely to provide assistance 4. Unclear if caregiver will assist patient 5. Assistance is needed but is not available
Outcome measures
| Measure |
Standard Care
n=2 Participants
Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day\], daily diary, and protective pads or garments \[as needed\].
|
Educational-Medical-Behavioral
n=9 Participants
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 \[if needed\].
|
|---|---|---|
|
Caregiver's Ability and Willingness to Assist With ADLs at End of Treatment
|
0 units on a scale
Interval 0.0 to 0.0
|
0 units on a scale
Interval 0.0 to 1.0
|
Adverse Events
Educational-Medical-Behavioral
Standard Care
Serious adverse events
| Measure |
Educational-Medical-Behavioral
n=11 participants at risk
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 \[if needed\].
|
Standard Care
n=8 participants at risk
Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day\], daily diary, and protective pads or garments \[as needed\].
|
|---|---|---|
|
Nervous system disorders
Disability
|
0.00%
0/11 • 7 month period from baseline visit to 6 month follow-up visit
Adverse events were reported to the study team by the home health care nurses, often as a reason for discontinuation of treatment.
|
12.5%
1/8 • Number of events 1 • 7 month period from baseline visit to 6 month follow-up visit
Adverse events were reported to the study team by the home health care nurses, often as a reason for discontinuation of treatment.
|
Other adverse events
Adverse event data not reported
Additional Information
William E. Whitehead, PhD, Professor of Medicine
University of North Carolina at Chapel Hill
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place