Clinical trial NCT01717456: Educational-Medical-Behavioral Treatment of Fecal Incontinence
Official title: Conservative Treatment of Fecal Incontinence: Community-Based Effectiveness Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Fecal Incontinence
Keywords: Fecal incontinence
Frail elders
Home health care
Nurse
Patient education
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2012-10-30
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Fecal Incontinence Severity Index (FISI) at End of Treatment
timeFrame: End of Treatment (Week 6)
measure: Fecal Incontinence Severity Index (FISI) at Follow-Up (FU)
timeFrame: 6 months after (6-Week) treatment ends
Secondary outcomes:
measure: Adequate Relief of Fecal Incontinence at End of Treatment
timeFrame: End of Treatment (Week 6)
measure: Adequate Relief of Fecal Incontinence at Follow Up
timeFrame: 6 months after (6-Week) treatment ends
measure: MHQ Severity Scale at End of Treatment
timeFrame: End of Treatment (Week 6)
measure: MHQ Severity Scale at Follow Up
timeFrame: 6 months after (6-Week) treatment ends
measure: Zarit Caregiver Burden Scale at End of Treatment
timeFrame: End of Treatment (Week 6)
measure: Zarit Caregiver Burden Scale at Follow Up
timeFrame: 6 months after (6-Week) treatment ends
measure: Fecal Incontinence Frequency at End of Treatment
timeFrame: End of Treatment (Week 6)
measure: Urinary Incontinence Status Change From Baseline to End of Treatment
timeFrame: Baseline, end of treatment (week 6)
measure: Admission to Nursing Home at End of Treatment
timeFrame: End of Treatment (Week 6)
measure: MHQ Incontinence Impact at End of Treatment
timeFrame: End of Treatment (Week 6)
measure: MHQ Incontinence Impact at Follow Up
timeFrame: 6 months after (6-Week) treatment ends
measure: MHQ Role Limitations at End of Treatment
timeFrame: End of Treatment (Week 6)
measure: MHQ Role Limitations at Follow Up
timeFrame: 6 months after (6-Week) treatment ends
measure: MHQ Physical Limitations at End of Treatment
timeFrame: End of Treatment (Week 6)
measure: MHQ Physical Limitations at Follow Up
timeFrame: 6 months after (6-Week) treatment ends
measure: MHQ Social Limitations at End of Treatment
timeFrame: End of Treatment (Week 6)
measure: MHQ Social Limitations at Follow Up
timeFrame: 6 months after (6-Week) treatment ends
measure: MHQ Personal Relationships at End of Treatment
timeFrame: End of Treatment (Week 6)
measure: MHQ Personal Relationships at Follow Up
timeFrame: 6 months after (6-Week) treatment ends
measure: MHQ Emotions at End of Treatment
timeFrame: End of Treatment (Week 6)
measure: MHQ Emotions at Follow Up
timeFrame: 6 months after (6-Week) treatment ends
measure: MHQ Sleep Energy at End of Treatment
timeFrame: End of Treatment (Week 6)
measure: MHQ Sleep Energy at Follow Up
timeFrame: 6 months after (6-Week) treatment ends
Other outcomes:
measure: Cognitive Status at End of Treatment
timeFrame: End of Treatment (Week 6)
measure: Change in Ambulation From Baseline to End of Treatment
timeFrame: Baseline, End of Treatment (Week 6)
measure: Ability to Reach Toilet at End of Treatment
timeFrame: End of Treatment (Week 6)
measure: When is Patient Anxious at End of Treatment?
timeFrame: End of Treatment (Week 6)
measure: Depression Screening at End of Treatment
timeFrame: End of Treatment (Week 6)
measure: Patient's Living Situation at End of Treatment
timeFrame: End of Treatment (Week 6)
measure: Caregiver's Ability and Willingness to Assist With ADLs at End of Treatment
timeFrame: End of Treatment (Week 6)
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: William E Whitehead, PhD
role: PRINCIPAL_INVESTIGATOR
References: