Fecal Incontinence
Conditions
Keywords
Fecal incontinence, Frail elders, Home health care, Nurse, Patient education
Brief summary
In previous studies at a university referral center the investigators demonstrated that a multicomponent conservative treatment for fecal incontinence was effective. The treatment combines patient education with medical management of diarrhea and constipation plus behavioral training. The purpose of this study is to determine whether this treatment is effective when delivered by home health care nurses to frail elderly patients.
Detailed description
Fecal incontinence (FI) affects 9% of U.S. adults and occurs weekly or more often in 2.7%. Prevalence increases with age reaching 15% by 70 years. FI has a devastating impact on quality of life and substantially increases caregiver burden when patients have comorbid conditions requiring caregiver assistance. The investigators propose an effectiveness trial whose overall goal is to determine whether a conservative intervention which has been shown to be effective in single-site studies will sustain its efficacy when disseminated to a home bound population by home health care nurses. The treatment includes patient education about the physiology of how continence is maintained, pelvic floor exercises, behavioral strategies for preventing FI, and use of fiber or nonprescription medication to treat diarrhea or constipation. To minimize drift when the treatment is disseminated to a large group of providers, patient education and other basic components of treatment are included in a printed training manual and are available to nurse providers on a website; however, nurse supervision to individualize treatment remains important. The study will be carried out in 8 counties in central North Carolina which are served by the University of North Carolina Home Health Care and Rex Home Health Care agencies (partners in this study). Nurses in these agencies will be randomly assigned to two groups. For the first two years all patients of the nurses in one group will receive the active intervention while all patients of nurses in the other group will receive usual care plus a training manual and symptom monitoring to control for expectancy. After two years, all patients in these home health care agencies will receive the active intervention. After excluding patients with severe cognitive impairment and those with stomas, the investigators estimate 252 - 340 patients with FI who are over age 50 will receive treatment (at least 189 in active treatment and 63 controls). Specific aims are (1) to show that the active treatment is more effective than the control treatment for improving FI severity, patient quality of life, and caregiver burden, and that improvements are maintained for at least 6 months; (2) to identify moderators of treatment effectiveness (candidate variables are cognitive status, mobility impairment, willingness of family caregiver to assist with treatment, anxiety, depression, age, and race); and (3) to explore whether successful treatment of FI reduces the risk of nursing home referral.
Interventions
OTHEREducation
Patient and caregiver will be taught which muscles are used in continence and defecation through the use of a training manual and anatomical drawings.
DIETARY_SUPPLEMENTFiber supplements
Patients and caregivers will be taught to use fiber supplements to normalize stool consistency if patient reports diarrhea or constipation. Fiber supplements will be in the form of Metamucil beginning with 3.4 grams per day and increasing up to 13.6 grams per day if needed to control stool consistency.
DRUGLaxatives or anti-diarrheals
Miralax at a dose of one packet (17 grams) daily may be used for constipation if unresponsive to fiber. Dose may be titrated up to two packets (34 grams) daily if needed. Imodium at a starting dose of 2 mg/day may be used for diarrhea if unresponsive to fiber. Dose of Imodium may be titrated down to 1 mg or up to 4 mg if needed.
BEHAVIORALPelvic floor muscle exercises
Patients will be taught how to perform pelvic floor muscle contractions during digital rectal examination by a nurse. They will be asked to squeeze 100 times daily.
BEHAVIORALTips on how to prevent fecal incontinence
Examples of behavioral tips are Walk, don't run to the toilet and Squeeze before you lift objects or sneeze.
BEHAVIORALDaily diary
Both groups will keep a daily diary, but amount of detail differs: Active comparator group records bowel accidents, bowel movements, Bristol Stool ratings of stool consistency, number of times they do pelvic floor exercises, study medications, and comments for the nurse to read. Placebo comparator group records only bowel accidents, bowel movements, and Bristol Stool scores.
OTHERProtective pads or garments
In both groups, patients will be permitted to use pads or protective garments to avoid embarrassment. They will be told that fecal leakage that is stopped by a pad or protective garment should still be recorded as fecal incontinence.
Sponsors
Agency for Healthcare Research and Quality (AHRQ)
University of North Carolina, Chapel Hill
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Self-reported fecal incontinence at least once a month * Family caregiver available and willing to participate in treatment sessions and willing to assist patient with study procedures * Patients and caregivers willing to be interviewed by a research assistant in their home on three occasions * Onset of fecal incontinence more than 3 months previously (i.e., not transient fecal incontinence)
Exclusion criteria
* Has a stoma or fecal incontinence status is unknown * Has fecal incontinence less than monthly * Severe cognitive impairment (response of 4 on OASIS question M1700)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fecal Incontinence Severity Index (FISI) at End of Treatment | End of Treatment (Week 6) | 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. |
| Fecal Incontinence Severity Index (FISI) at Follow-Up (FU) | 6 months after (6-Week) treatment ends | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MHQ Incontinence Impact at End of Treatment | End of Treatment (Week 6) | 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. |
| MHQ Social Limitations at Follow Up | 6 months after (6-Week) treatment ends | 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. |
| MHQ Personal Relationships at End of Treatment | End of Treatment (Week 6) | 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. |
| MHQ Personal Relationships at Follow Up | 6 months after (6-Week) treatment ends | 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. |
| MHQ Emotions at End of Treatment | End of Treatment (Week 6) | 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. |
| MHQ Emotions at Follow Up | 6 months after (6-Week) treatment ends | 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. |
| MHQ Sleep Energy at End of Treatment | End of Treatment (Week 6) | 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. |
| MHQ Sleep Energy at Follow Up | 6 months after (6-Week) treatment ends | 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. |
| Adequate Relief of Fecal Incontinence at End of Treatment | End of Treatment (Week 6) | 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. |
| Adequate Relief of Fecal Incontinence at Follow Up | 6 months after (6-Week) treatment ends | 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. |
| MHQ Severity Scale at End of Treatment | End of Treatment (Week 6) | 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. |
| MHQ Severity Scale at Follow Up | 6 months after (6-Week) treatment ends | 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. |
| Zarit Caregiver Burden Scale at End of Treatment | End of Treatment (Week 6) | 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. |
| Zarit Caregiver Burden Scale at Follow Up | 6 months after (6-Week) treatment ends | 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. |
| Fecal Incontinence Frequency at End of Treatment | End of Treatment (Week 6) | 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 |
| Urinary Incontinence Status Change From Baseline to End of Treatment | Baseline, end of treatment (week 6) | 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) |
| Admission to Nursing Home at End of Treatment | End of Treatment (Week 6) | 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. |
| MHQ Incontinence Impact at Follow Up | 6 months after (6-Week) treatment ends | 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. |
| MHQ Role Limitations at End of Treatment | End of Treatment (Week 6) | 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. |
| MHQ Role Limitations at Follow Up | 6 months after (6-Week) treatment ends | 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. |
| MHQ Physical Limitations at End of Treatment | End of Treatment (Week 6) | 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. |
| MHQ Physical Limitations at Follow Up | 6 months after (6-Week) treatment ends | 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. |
| MHQ Social Limitations at End of Treatment | End of Treatment (Week 6) | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Ability to Reach Toilet at End of Treatment | End of Treatment (Week 6) | 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. |
| When is Patient Anxious at End of Treatment? | End of Treatment (Week 6) | 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 |
| Depression Screening at End of Treatment | End of Treatment (Week 6) | 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 |
| Patient's Living Situation at End of Treatment | End of Treatment (Week 6) | 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. |
| Cognitive Status at End of Treatment | End of Treatment (Week 6) | 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. |
| Caregiver's Ability and Willingness to Assist With ADLs at End of Treatment | End of Treatment (Week 6) | 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 |
| Change in Ambulation From Baseline to End of Treatment | Baseline, End of Treatment (Week 6) | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 \[if needed\]. | 11 |
| Standard Care Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day\], daily diary, and protective pads or garments \[as needed\]. | 8 |
| Total | 19 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| End of Treatment | Lost to Follow-up | 0 | 1 |
| End of Treatment | Physician Decision | 0 | 1 |
| Follow-Up 6 Months After End of Tx | Lost to Follow-up | 4 | 4 |
Baseline characteristics
| Characteristic | Total | Educational-Medical-Behavioral | Standard Care |
|---|---|---|---|
| Ability to use toilet at Baseline | 0 participants | 0 participants | 0 participants |
| Age, Continuous | 85.83 years STANDARD_DEVIATION 4.17 | 86.11 years STANDARD_DEVIATION 4.51 | 85.00 years STANDARD_DEVIATION 3.61 |
| Ambulation at Baseline | 0.2 units on a scale | 0 units on a scale | 0.5 units on a scale |
| Cognitive Function at Baseline | 0 units on a scale | 0 units on a scale | 0 units on a scale |
| Depression Screening at Baseline Not screened for depression | 9 participants | 8 participants | 1 participants |
| Depression Screening at Baseline Requires further evaluation | 0 participants | 0 participants | 0 participants |
| Depression Screening at Baseline Screened and does not need further evaluation | 0 participants | 0 participants | 0 participants |
| Depression Screening at Baseline Screened by Patient Health Questionnaire 2 (PHQ2) | 2 participants | 1 participants | 1 participants |
| Depression Screening at Baseline Unknown | 8 participants | 2 participants | 6 participants |
| Fecal Incontinence Severity Index (FISI) at Baseline | 23.72 units on a scale STANDARD_DEVIATION 2.44 | 24.50 units on a scale STANDARD_DEVIATION 12.22 | 22.75 units on a scale STANDARD_DEVIATION 8.14 |
| Frequency of fecal incontinence at Baseline | 2 units on a scale | 2 units on a scale | 4.5 units on a scale |
| Living Situation at Baseline Lives alone | 3 participants | 3 participants | 0 participants |
| Living Situation at Baseline Lives in assisted living | 2 participants | 2 participants | 0 participants |
| Living Situation at Baseline Lives with another adult | 6 participants | 4 participants | 2 participants |
| Living Situation at Baseline Unknown | 8 participants | 2 participants | 6 participants |
| Manchester Health Questionnaire (MHQ) Severity Scale at Baseline | 49.21 units on a scale STANDARD_DEVIATION 17.42 | 48.64 units on a scale STANDARD_DEVIATION 17.76 | 50.00 units on a scale STANDARD_DEVIATION 18.13 |
| MHQ Emotions at Baseline | 32.89 units on a scale STANDARD_DEVIATION 26.57 | 19.70 units on a scale STANDARD_DEVIATION 15.49 | 51.04 units on a scale STANDARD_DEVIATION 28.67 |
| MHQ Incontinence Impact at Baseline | 57.89 units on a scale STANDARD_DEVIATION 25.07 | 52.27 units on a scale STANDARD_DEVIATION 23.6 | 65.63 units on a scale STANDARD_DEVIATION 26.52 |
| MHQ Personal Relationships at Baseline | 13.64 units on a scale STANDARD_DEVIATION 25.89 | 8.33 units on a scale STANDARD_DEVIATION 20.41 | 20.00 units on a scale STANDARD_DEVIATION 32.6 |
| MHQ Physical Limitations at Baseline | 31.58 units on a scale STANDARD_DEVIATION 28.98 | 18.18 units on a scale STANDARD_DEVIATION 21.91 | 50.00 units on a scale STANDARD_DEVIATION 28.35 |
| MHQ Role Limitations at Baseline | 28.95 units on a scale STANDARD_DEVIATION 32.56 | 13.64 units on a scale STANDARD_DEVIATION 26.49 | 50.00 units on a scale STANDARD_DEVIATION 29.12 |
| MHQ Sleep Energy at Baseline | 14.47 units on a scale STANDARD_DEVIATION 22.15 | 7.95 units on a scale STANDARD_DEVIATION 14 | 23.44 units on a scale STANDARD_DEVIATION 28.69 |
| MHQ Social Limitations at Baseline | 28.07 units on a scale STANDARD_DEVIATION 33.93 | 16.67 units on a scale STANDARD_DEVIATION 29.11 | 43.75 units on a scale STANDARD_DEVIATION 35.57 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants | 0 Participants | 5 Participants |
| Race (NIH/OMB) White | 13 Participants | 10 Participants | 3 Participants |
| Sex: Female, Male Female | 16 Participants | 11 Participants | 5 Participants |
| Sex: Female, Male Male | 3 Participants | 0 Participants | 3 Participants |
| Source of Assistance with ADLs at Baseline Assistance needed but not available | 0 participants | 0 participants | 0 participants |
| Source of Assistance with ADLs at Baseline Caregiver needs training or support | 0 participants | 0 participants | 0 participants |
| Source of Assistance with ADLs at Baseline Caregiver provides assistance | 3 participants | 3 participants | 0 participants |
| Source of Assistance with ADLs at Baseline Caregiver unlikely to provide assistance | 0 participants | 0 participants | 0 participants |
| Source of Assistance with ADLs at Baseline No assistance needed | 7 participants | 5 participants | 2 participants |
| Source of Assistance with ADLs at Baseline Unclear if caregiver will assist patient | 0 participants | 0 participants | 0 participants |
| Source of Assistance with ADLs at Baseline Unknown | 9 participants | 3 participants | 6 participants |
| Urinary Continence Status at Baseline | 1 units on a scale | 1 units on a scale | 0.5 units on a scale |
| When is patient anxious at Baseline? | 0 units on a scale | 0 units on a scale | 0 units on a scale |
| Zarit Caregiver Burden Scale at Baseline | 22.75 units on a scale STANDARD_DEVIATION 14.13 | 36.00 units on a scale STANDARD_DEVIATION 42.43 | 18.33 units on a scale STANDARD_DEVIATION 13.5 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 11 | 0 / 8 |
| serious Total, serious adverse events | 0 / 11 | 1 / 8 |
Outcome results
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Educational-Medical-Behavioral | Fecal Incontinence Severity Index (FISI) at End of Treatment | 18.00 units on a scale | Standard Deviation 10.3 |
| Standard Care | Fecal Incontinence Severity Index (FISI) at End of Treatment | 22.00 units on a scale | Standard Deviation 9.17 |
p-value: 0.05t-test, 2 sided
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.
Time frame: 6 months after (6-Week) treatment ends
Population: The analysis sample consists of all patients who provided data at the 6 month FU visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Educational-Medical-Behavioral | Fecal Incontinence Severity Index (FISI) at Follow-Up (FU) | 14.86 units on a scale | Standard Deviation 12.71 |
| Standard Care | Fecal Incontinence Severity Index (FISI) at Follow-Up (FU) | 37.00 units on a scale | Standard Deviation 21.21 |
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.
Time frame: End of Treatment (Week 6)
Population: Data not available for 1/11 Educational-Medical-Behavioral group subject and for 2/8 Standard Care subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Educational-Medical-Behavioral | Adequate Relief of Fecal Incontinence at End of Treatment | Yes, Adequate Relief | 5 participants |
| Educational-Medical-Behavioral | Adequate Relief of Fecal Incontinence at End of Treatment | No, No Adequate Relief | 5 participants |
| Educational-Medical-Behavioral | Adequate Relief of Fecal Incontinence at End of Treatment | Unknown | 0 participants |
| Standard Care | Adequate Relief of Fecal Incontinence at End of Treatment | Yes, Adequate Relief | 1 participants |
| Standard Care | Adequate Relief of Fecal Incontinence at End of Treatment | No, No Adequate Relief | 3 participants |
| Standard Care | Adequate Relief of Fecal Incontinence at End of Treatment | Unknown | 2 participants |
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.
Time frame: 6 months after (6-Week) treatment ends
Population: Data not available for 3/7 Educational-Medical-Behavioral group subject and for 2/2 Standard Care subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Educational-Medical-Behavioral | Adequate Relief of Fecal Incontinence at Follow Up | Yes, Adequate Relief | 1 participants |
| Educational-Medical-Behavioral | Adequate Relief of Fecal Incontinence at Follow Up | No, no Adequate Relief | 3 participants |
| Educational-Medical-Behavioral | Adequate Relief of Fecal Incontinence at Follow Up | Unknown | 3 participants |
| Standard Care | Adequate Relief of Fecal Incontinence at Follow Up | Yes, Adequate Relief | 0 participants |
| Standard Care | Adequate Relief of Fecal Incontinence at Follow Up | No, no Adequate Relief | 0 participants |
| Standard Care | Adequate Relief of Fecal Incontinence at Follow Up | Unknown | 2 participants |
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.
Time frame: End of Treatment (Week 6)
Population: Analysis sample was all patients who provided data at end of treatment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Educational-Medical-Behavioral | Admission to Nursing Home at End of Treatment | Admitted to nursing home | 0 participants |
| Educational-Medical-Behavioral | Admission to Nursing Home at End of Treatment | Not admitted to nursing home | 8 participants |
| Standard Care | Admission to Nursing Home at End of Treatment | Admitted to nursing home | 0 participants |
| Standard Care | Admission to Nursing Home at End of Treatment | Not admitted to nursing home | 2 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 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
Time frame: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Educational-Medical-Behavioral | Fecal Incontinence Frequency at End of Treatment | 1 units on a scale |
| Standard Care | Fecal Incontinence Frequency at End of Treatment | 2 units on a scale |
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.
Time frame: End of Treatment (Week 6)
Population: All subjects completing end of treatment home visit with research assistant.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Educational-Medical-Behavioral | MHQ Emotions at End of Treatment | 24.17 units on a scale | Standard Deviation 29.52 |
| Standard Care | MHQ Emotions at End of Treatment | 50.00 units on a scale | Standard Deviation 38.64 |
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.
Time frame: 6 months after (6-Week) treatment ends
Population: All subjects completing end of treatment home visit with research assistant.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Educational-Medical-Behavioral | MHQ Emotions at Follow Up | 13.10 units on a scale | Standard Deviation 13.49 |
| Standard Care | MHQ Emotions at Follow Up | 12.50 units on a scale | Standard Deviation 5.89 |
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.
Time frame: End of Treatment (Week 6)
Population: All subjects completing end of treatment home visit with research assistant.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Educational-Medical-Behavioral | MHQ Incontinence Impact at End of Treatment | 42.50 units on a scale | Standard Deviation 23.72 |
| Standard Care | MHQ Incontinence Impact at End of Treatment | 70.00 units on a scale | Standard Deviation 20.92 |
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.
Time frame: 6 months after (6-Week) treatment ends
Population: All subjects completing end of treatment home visit with research assistant.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Educational-Medical-Behavioral | MHQ Incontinence Impact at Follow Up | 35.71 units on a scale | Standard Deviation 24.4 |
| Standard Care | MHQ Incontinence Impact at Follow Up | 25.00 units on a scale | Standard Deviation 0 |
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.
Time frame: End of Treatment (Week 6)
Population: All subjects completing end of treatment home visit with research assistant.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Educational-Medical-Behavioral | MHQ Personal Relationships at End of Treatment | 0 units on a scale | Standard Deviation 0 |
| Standard Care | MHQ Personal Relationships at End of Treatment | 25.00 units on a scale | Standard Deviation 35.36 |
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.
Time frame: 6 months after (6-Week) treatment ends
Population: All subjects completing end of treatment home visit with research assistant.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Educational-Medical-Behavioral | MHQ Personal Relationships at Follow Up | 0 units on a scale | Standard Deviation 0 |
| Standard Care | MHQ Personal Relationships at Follow Up | 0 units on a scale | Standard Deviation 0 |
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.
Time frame: End of Treatment (Week 6)
Population: All subjects completing end of treatment home visit with research assistant.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Educational-Medical-Behavioral | MHQ Physical Limitations at End of Treatment | 18.75 units on a scale | Standard Deviation 31.87 |
| Standard Care | MHQ Physical Limitations at End of Treatment | 60.00 units on a scale | Standard Deviation 32.36 |
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.
Time frame: 6 months after (6-Week) treatment ends
Population: All subjects completing end of treatment home visit with research assistant.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Educational-Medical-Behavioral | MHQ Physical Limitations at Follow Up | 7.14 units on a scale | Standard Deviation 18.9 |
| Standard Care | MHQ Physical Limitations at Follow Up | 31.25 units on a scale | Standard Deviation 8.84 |
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.
Time frame: End of Treatment (Week 6)
Population: All subjects completing end of treatment home visit with research assistant.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Educational-Medical-Behavioral | MHQ Role Limitations at End of Treatment | 16.25 units on a scale | Standard Deviation 28.9 |
| Standard Care | MHQ Role Limitations at End of Treatment | 57.50 units on a scale | Standard Deviation 34.91 |
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.
Time frame: 6 months after (6-Week) treatment ends
Population: All subjects completing end of treatment home visit with research assistant.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Educational-Medical-Behavioral | MHQ Role Limitations at Follow Up | 14.29 units on a scale | Standard Deviation 19.67 |
| Standard Care | MHQ Role Limitations at Follow Up | 12.50 units on a scale | Standard Deviation 17.68 |
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.
Time frame: End of Treatment (Week 6)
Population: All subjects completing end of treatment home visit with research assistant.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Educational-Medical-Behavioral | MHQ Severity Scale at End of Treatment | 42.50 units on a scale | Standard Deviation 28.41 |
| Standard Care | MHQ Severity Scale at End of Treatment | 55.00 units on a scale | Standard Deviation 23.72 |
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.
Time frame: 6 months after (6-Week) treatment ends
Population: All subjects completing end of treatment home visit with research assistant.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Educational-Medical-Behavioral | MHQ Severity Scale at Follow Up | 39.29 units on a scale | Standard Deviation 25.4 |
| Standard Care | MHQ Severity Scale at Follow Up | 47.50 units on a scale | Standard Deviation 31.82 |
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.
Time frame: End of Treatment (Week 6)
Population: All subjects completing end of treatment home visit with research assistant.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Educational-Medical-Behavioral | MHQ Sleep Energy at End of Treatment | 10.00 units on a scale | Standard Deviation 17.48 |
| Standard Care | MHQ Sleep Energy at End of Treatment | 32.50 units on a scale | Standard Deviation 20.92 |
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.
Time frame: 6 months after (6-Week) treatment ends
Population: All subjects completing end of treatment home visit with research assistant.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Educational-Medical-Behavioral | MHQ Sleep Energy at Follow Up | 3.57 units on a scale | Standard Deviation 6.1 |
| Standard Care | MHQ Sleep Energy at Follow Up | 0 units on a scale | Standard Deviation 0 |
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.
Time frame: End of Treatment (Week 6)
Population: All subjects completing end of treatment home visit with research assistant.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Educational-Medical-Behavioral | MHQ Social Limitations at End of Treatment | 15.83 units on a scale | Standard Deviation 26.77 |
| Standard Care | MHQ Social Limitations at End of Treatment | 48.33 units on a scale | Standard Deviation 43.46 |
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.
Time frame: 6 months after (6-Week) treatment ends
Population: All subjects completing end of treatment home visit with research assistant.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Educational-Medical-Behavioral | MHQ Social Limitations at Follow Up | 2.38 units on a scale | Standard Deviation 6.3 |
| Standard Care | MHQ Social Limitations at Follow Up | 4.17 units on a scale | Standard Deviation 5.89 |
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) 1. \- Patient is incontinent 2. \- Patient requires a urinary catheter (i.e., external, indwelling, intermittent, suprapubic)
Time frame: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Educational-Medical-Behavioral | Urinary Incontinence Status Change From Baseline to End of Treatment | 1 units on a scale |
| Standard Care | Urinary Incontinence Status Change From Baseline to End of Treatment | 0.50 units on a scale |
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.
Time frame: End of Treatment (Week 6)
Population: Family caregivers of patients completing the study. Some caregivers declined or no caregiver was available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Educational-Medical-Behavioral | Zarit Caregiver Burden Scale at End of Treatment | 33.00 units on a scale | Standard Deviation 42.43 |
| Standard Care | Zarit Caregiver Burden Scale at End of Treatment | 30.50 units on a scale | Standard Deviation 23.34 |
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.
Time frame: 6 months after (6-Week) treatment ends
Population: Family caregivers of patients completing the study. Some caregivers declined or no caregiver was available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Educational-Medical-Behavioral | Zarit Caregiver Burden Scale at Follow Up | 14.00 units on a scale | Standard Deviation 14 |
| Standard Care | Zarit Caregiver Burden Scale at Follow Up | 25.50 units on a scale | Standard Deviation 20.51 |
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. 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.
Time frame: End of Treatment (Week 6)
Population: All patients who provided data for this measure at the end of treatment.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Educational-Medical-Behavioral | Ability to Reach Toilet at End of Treatment | 0 units on a scale |
| Standard Care | Ability to Reach Toilet at End of Treatment | 0 units on a scale |
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 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
Time frame: End of Treatment (Week 6)
Population: Analysis population consists of all patients who provided data at end of treatment
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Educational-Medical-Behavioral | Caregiver's Ability and Willingness to Assist With ADLs at End of Treatment | 0 units on a scale |
| Standard Care | Caregiver's Ability and Willingness to Assist With ADLs at End of Treatment | 0 units on a scale |
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). 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.
Time frame: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Educational-Medical-Behavioral | Change in Ambulation From Baseline to End of Treatment | 0 units on a scale |
| Standard Care | Change in Ambulation From Baseline to End of Treatment | 0 units on a scale |
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. 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.
Time frame: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Educational-Medical-Behavioral | Cognitive Status at End of Treatment | 0 units on a scale |
| Standard Care | Cognitive Status at End of Treatment | 0 units on a scale |
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 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
Time frame: End of Treatment (Week 6)
Population: Analysis population consists of all patients providing data at end of treatment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Educational-Medical-Behavioral | Depression Screening at End of Treatment | No screening | 7 participants |
| Educational-Medical-Behavioral | Depression Screening at End of Treatment | Screened by PHQ2 | 2 participants |
| Educational-Medical-Behavioral | Depression Screening at End of Treatment | Meets criteria for further evaluation of depressio | 0 participants |
| Educational-Medical-Behavioral | Depression Screening at End of Treatment | Does not meet criteria for further evaluation | 0 participants |
| Standard Care | Depression Screening at End of Treatment | Does not meet criteria for further evaluation | 0 participants |
| Standard Care | Depression Screening at End of Treatment | No screening | 2 participants |
| Standard Care | Depression Screening at End of Treatment | Meets criteria for further evaluation of depressio | 0 participants |
| Standard Care | Depression Screening at End of Treatment | Screened by PHQ2 | 0 participants |
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.
Time frame: End of Treatment (Week 6)
Population: Analysis population consists of all patients who provided data at end of treatment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Educational-Medical-Behavioral | Patient's Living Situation at End of Treatment | Lives alone | 3 participants |
| Educational-Medical-Behavioral | Patient's Living Situation at End of Treatment | Lives with another adult | 3 participants |
| Educational-Medical-Behavioral | Patient's Living Situation at End of Treatment | Lives in assisted living | 3 participants |
| Standard Care | Patient's Living Situation at End of Treatment | Lives alone | 0 participants |
| Standard Care | Patient's Living Situation at End of Treatment | Lives in assisted living | 0 participants |
| Standard Care | Patient's Living Situation at End of Treatment | Lives with another adult | 2 participants |
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 1. \- Less often than daily 2. \- Daily, but not constantly 3. \- All of the time
Time frame: End of Treatment (Week 6)
Population: Analysis population consists of all patients who provided end of treatment data.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Educational-Medical-Behavioral | When is Patient Anxious at End of Treatment? | 0 units on a scale |
| Standard Care | When is Patient Anxious at End of Treatment? | 0 units on a scale |