Educational-Medical-Behavioral Treatment of Fecal Incontinence

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.

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)