Educational-Medical-Behavioral Treatment of Fecal Incontinence

NCT ID: NCT01717456

Last Updated: 2017-02-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2015-03-31

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.

Conditions

Fecal Incontinence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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 \[as needed\].

Group Type: ACTIVE_COMPARATOR

Education

Intervention Type: OTHER

Patient and caregiver will be taught which muscles are used in continence and defecation through the use of a training manual and anatomical drawings.

Fiber supplements

Intervention Type: DIETARY_SUPPLEMENT

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.

Laxatives or anti-diarrheals

Intervention Type: DRUG

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.

Pelvic floor muscle exercises

Intervention Type: BEHAVIORAL

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.

Tips on how to prevent fecal incontinence

Intervention Type: BEHAVIORAL

Examples of behavioral tips are "Walk, don't run to the toilet" and "Squeeze before you lift objects or sneeze".

Daily diary

Intervention Type: BEHAVIORAL

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.

Protective pads or garments

Intervention Type: OTHER

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.

Standard Care

Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day\], daily diary, and protective pads or garments \[as needed\].

Group Type: PLACEBO_COMPARATOR

Fiber supplements

Intervention Type: DIETARY_SUPPLEMENT

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.

Daily diary

Intervention Type: BEHAVIORAL

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.

Protective pads or garments

Intervention Type: OTHER

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.

Interventions

Education

Patient and caregiver will be taught which muscles are used in continence and defecation through the use of a training manual and anatomical drawings.

Intervention Type: OTHER

Fiber 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.

Intervention Type: DIETARY_SUPPLEMENT

Laxatives 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.

Intervention Type: DRUG

Pelvic 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.

Intervention Type: BEHAVIORAL

Tips 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".

Intervention Type: BEHAVIORAL

Daily 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.

Intervention Type: BEHAVIORAL

Protective 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.

Intervention Type: OTHER

Other Intervention Names

Miralax (polyethylene glycol); Imodium (loperamide); Continence pads

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Agency for Healthcare Research and Quality (AHRQ)

FED

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

William (Bill) Whitehead, PhD

Professor of Medicine and Adjunct Professor of OBGYN

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

William E Whitehead, PhD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Countries

United States

Other Identifiers

R01HS018695

Identifier Type: AHRQ

Identifier Source: secondary_id

View Link

11-1569

Identifier Type: -

Identifier Source: org_study_id