Educational-Medical-Behavioral Treatment of Fecal Incontinence — FIX  

Fecal Incontinence Clinical Trial

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

Status Terminated

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Fecal Incontinence

• NCT number: NCT01717456
• Study type: Interventional
• Source: University of North Carolina, Chapel Hill
• Status: Terminated
• Phase: N/A
• Start date: January 2013
• Completion date: March 2015