Educational-Medical-Behavioral Treatment of Fecal Incontinence

Not Applicable

Terminated

Conditions: Fecal Incontinence

Interventions: 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

Registration Number: NCT01717456

Lead Sponsor: University of North Carolina, Chapel Hill

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 31

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)

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Educational-Medical-Behavioral	Laxatives or anti-diarrheals	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 \[as needed\].
Educational-Medical-Behavioral	Pelvic floor muscle exercises	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 \[as needed\].
Educational-Medical-Behavioral	Education	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 \[as needed\].
Educational-Medical-Behavioral	Fiber supplements	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 \[as needed\].
Educational-Medical-Behavioral	Tips on how to prevent fecal incontinence	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 \[as needed\].
Educational-Medical-Behavioral	Daily diary	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 \[as needed\].
Educational-Medical-Behavioral	Protective pads or garments	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	Fiber supplements	Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day\], daily diary, and protective pads or garments \[as needed\].
Standard Care	Daily diary	Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day\], daily diary, and protective pads or garments \[as needed\].
Standard Care	Protective pads or garments	Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day\], daily diary, and protective pads or garments \[as needed\].

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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 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.
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)
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.
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.
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 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 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 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 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 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.

Trial Locations

Locations (1): University of North Carolina at Chapel Hill
🇺🇸
Chapel Hill, North Carolina, United States

Educational-Medical-Behavioral Treatment of Fecal Incontinence

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