Educational-Medical-Behavioral Treatment of Fecal Incontinence

Study Overview
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Brief Summary
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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
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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.

Official Title
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Conservative Treatment of Fecal Incontinence: Community-Based Effectiveness Trial

Conditions
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Fecal Incontinence

Intervention / Treatment
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* Other: Education
* Dietary Supplement: Fiber supplements
* Drug: Laxatives or anti-diarrheals
* Behavioral: Pelvic floor muscle exercises
* Behavioral: Tips on how to prevent fecal incontinence
* Behavioral: Daily diary
* Other: Protective pads or garments


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Educational-Medical-Behavioral<br>Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives or anti-diarrheals [Miralax 1-2 packets (17-34 g)/day or Imodium 0.5-2 tablets (1-4 mg)/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, daily diary, and protective pads or garments [as needed]. | Other: Education<br>* Patient and caregiver will be taught which muscles are used in continence and defecation through the use of a training manual and anatomical drawings.<br>Dietary Supplement: Fiber supplements<br>* 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.<br>Drug: Laxatives or anti-diarrheals<br>* 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.<br>* Other names: Imodium (loperamide);Behavioral: Pelvic floor muscle exercises<br>* 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.<br>Behavioral: Tips on how to prevent fecal incontinence<br>* Examples of behavioral tips are Walk, don't run to the toilet and Squeeze before you lift objects or sneeze.<br>Behavioral: Daily diary<br>* 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.<br>Other: Protective pads or garments<br>* 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.<br>* Other names: Continence pads;|
| Placebo Comparator: Standard Care<br>Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed]. | Dietary Supplement: Fiber supplements<br>* 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.<br>Behavioral: Daily diary<br>* 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.<br>Other: Protective pads or garments<br>* 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.<br>* Other names: Continence pads;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adequate Relief of Fecal Incontinence at End of Treatment | At the end of treatment, the subject is asked, Compared to before you started home health care, have you experienced adequate relief of your fecal incontinence symptoms? [Responses: yes or no]. A responder is anyone answering yes. A treatment would be judged successful if there was at least 10% more responders in the active compared to the control groups. | End of Treatment (Week 6) | 
| 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. | 6 months after (6-Week) treatment ends | 
| 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. | End of Treatment (Week 6) | 
| 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. | 6 months after (6-Week) treatment ends | 
| 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. | End of Treatment (Week 6) | 
| 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. | 6 months after (6-Week) treatment ends | 
| Fecal Incontinence Frequency at End of Treatment | OASIS question M1620: Bowel incontinence frequency. Response options are: 0 - Very rarely or never has bowel incontinence - Less than once weekly - One to three times weekly - Four to six times weekly - On a daily basis - More often than once daily | End of Treatment (Week 6) | 
| Urinary Incontinence Status Change From Baseline to End of Treatment | OASIS question M1610: Urinary incontinence or urinary catheter presence. Response options are: 0 - No incontinence or catheter (includes anuria or ostomy for urinary drainage) - Patient is incontinent - Patient requires a urinary catheter (i.e., external, indwelling, intermittent, suprapubic) | Baseline, end of treatment (week 6) | 
| 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. | End of Treatment (Week 6) | 
| 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. | End of Treatment (Week 6) | 
| 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. | 6 months after (6-Week) treatment ends | 
| 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. | End of Treatment (Week 6) | 
| 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. | 6 months after (6-Week) treatment ends | 
| 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. | End of Treatment (Week 6) | 
| 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. | 6 months after (6-Week) treatment ends | 
| 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. | End of Treatment (Week 6) | 
| 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. | 6 months after (6-Week) treatment ends | 
| 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. | End of Treatment (Week 6) | 
| 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. | 6 months after (6-Week) treatment ends | 
| 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. | End of Treatment (Week 6) | 
| 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. | 6 months after (6-Week) treatment ends | 
| 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. | End of Treatment (Week 6) | 
| 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. | 6 months after (6-Week) treatment ends | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fecal incontinence, Frail elders, Home health care, Nurse, Patient education