Educational-Medical-Behavioral Treatment of Fecal Incontinence (FIX)

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
William (Bill) Whitehead, PhD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01717456
First received: September 15, 2012
Last updated: November 8, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Fecal Incontinence
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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Conservative Treatment of Fecal Incontinence: Community-Based Effectiveness Trial

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Fecal Incontinence Severity Index [ Time Frame: Change from baseline to 6 weeks after treatment onset ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Zarit Caregiver Burden Interview [ Time Frame: Change from baseline to 6 weeks after treatment onset ] [ Designated as safety issue: No ]
    Validated questionnaire developed to assess the psychosocial and health burden experienced by a family caregiver of the identified patient.

  • Manchester Health Questionnaire [ Time Frame: Change from baseline to 6 weeks after treatment onset ] [ Designated as safety issue: No ]
    Quality of life scale specific to fecal incontinence. This scale was validated for interviewer administration.

  • Adequate relief of fecal incontinence [ Time Frame: 6 weeks after treatment onset ] [ Designated as safety issue: No ]

    "Compared to before you started home health care, have you experienced adequate relief of your fecal incontinence symptoms? [Responses: yes or no]".

    (This is the same secondary outcome measure that was used in a previous trial of conservative treatment of fecal incontinence.)


  • Fecal incontinence frequency [ Time Frame: Change from baseline to 6 weeks after treatment onset ] [ Designated as safety issue: No ]

    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 [ Time Frame: Change from baseline to 6 weeks after treatment onset ] [ Designated as safety issue: No ]

    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)

  • Admission to nursing home [ Time Frame: Change from baseline to follow-up 7-8 months following treatment onset ] [ Designated as safety issue: No ]
    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.

  • Hospitalizations [ Time Frame: Change from baseline to follow up 7-8 months after treatment onset ] [ Designated as safety issue: No ]
    Extracted from medical record by research assistant

  • Emergency department visits [ Time Frame: Change from baseline to follow up 7-8 months after treatment onset ] [ Designated as safety issue: No ]
    Extracted from medical record by research assistant.

  • Outpatient clinic visits [ Time Frame: Change from baseline to follow up 7-8 months after treatment onset ] [ Designated as safety issue: No ]
    Extracted from medical record by research assistant

  • Fecal Incontinence Severity Index (FISI) [ Time Frame: Change from baseline to follow-up 7-8 months after treatment.onset ] [ Designated as safety issue: No ]
    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.

  • Zarit Caregiver Burden Interview [ Time Frame: Change from baseline to follow up 7-8 months after treatment onset ] [ Designated as safety issue: No ]
    Validated questionnaire developed to assess the psychosocial and health burden experienced by a family caregiver of the identified patient.

  • Manchester Health Questionnaire [ Time Frame: Change from baseline to follow up 7-8 months following treatment onset ] [ Designated as safety issue: No ]
    Quality of life scale specific to fecal incontinence. This scale was validated for interviewer administration.

  • Fecal incontinence frequency [ Time Frame: Change from baseline to follow up 7-8 months after treatment onset ] [ Designated as safety issue: No ]

    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


Other Outcome Measures:
  • Cognitive status [ Time Frame: Baseline ] [ Designated as safety issue: No ]

    OASIS question M1700: Cognitive functioning: Patient's current (day of assessment) level of alertness, orientation, comprehension, concentration, and immediate memory for simple commands. Measure as treatment moderator. Response categories are:

    0 - Alert/oriented, able to focus and shift attention, comprehends and recalls task directions independently.

    1. - Requires prompting (cuing, repetition, reminders) only under stressful or unfamiliar conditions.
    2. - Requires assistance and some direction in specific situations (e.g., on all tasks involving shifting of attention), or consistently requires low stimulus environment due to distractibility.
    3. - Requires considerable assistance in routine situations. Is not alert and oriented or is unable to shift attention and recall directions more than half the time.
    4. - Totally dependent due to disturbances uch as constant disorientation, coma, persistent vegetative stte, or delirium.

  • Ambulation/locomotion [ Time Frame: Change from baseline to 6 weeks after treatment onset ] [ Designated as safety issue: No ]

    OASIS question M1860: Ambulation/locomotion: Current ability t walk safely, once in a standing position, or use a wheelchair, once in a seated position, on a variety of surfaces. Measure as a moderator of treatment effects. Responses:

    0 - Able to independently walk on even and uneven surfaces and negotiate stairs with or without railings (i.e., needs no human assistance or assistive device).

    ... 6 - Bedfast, unable to ambulate or be up in a chair.


  • Ability to reach toilet [ Time Frame: Change from baseline to 6 weeks after treatment onset ] [ Designated as safety issue: No ]

    OASIS question M1840: Toilet transferring: Current ability to get to and from the toilet or bedside commode safely and transfer on and off toilet/commode. Measure as moderator of treatment outcomes. Responses:

    0 - Able to get to and from teh toilet and transfer independently with or without a device.

    ... 4 - Is totally dependent in toileting.


  • Anxiety [ Time Frame: Change from baseline to end of 6 weeks after treatment onset ] [ Designated as safety issue: No ]

    OASIS question M1720: When anxious (reported or observed within the last 14 days). Measure as moderator of treatment effects. Responses are:

    0 - None of the time

    1. - Less often than daily
    2. - Daily, but not constantly
    3. - All of the time

  • Depression [ Time Frame: Change from baseline to 6 weeks after treatment onset ] [ Designated as safety issue: No ]
    OASIS question M1730: Depression Screening. Measure as a moderator of treatment effectiveness.

  • Patient's living situation [ Time Frame: Change from baseline to 6 weeks after treatment onset ] [ Designated as safety issue: No ]
    OASIS question M1100: Patient living situation: This is a measure that combines who lives with the patient and the frequency that assistance is available to them throughout the day. Responses are coded on a 1-15 scale. Measure this as a moderator of treatment effectiveness.

  • Caregiver's ability and willingness to assist with ADLs [ Time Frame: Change from baseline to 6 weeks after treatment onset ] [ Designated as safety issue: No ]
    OASIS question M2100, item A: Types and sources of assistance for ADLs. Measure as moderator of treatment effectiveness. Responses range from "No assistance needed in this area" to "Assistance needed, but no Caregivers available".


Estimated Enrollment: 252
Study Start Date: January 2013
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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].
Other: 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.
Dietary Supplement: 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.
Drug: 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.

Other Names:
  • Miralax (polyethylene glycol)
  • Imodium (loperamide)
Behavioral: 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.
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".
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.
Other: Protective pads or garments
Other Name: Continence pads
Placebo Comparator: 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].
Dietary Supplement: 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.
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.
Other: Protective pads or garments
Other Name: Continence pads

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01717456

Locations
United States, North Carolina
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7080
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
Principal Investigator: William E Whitehead, PhD University of North Carolina, Chapel Hill
  More Information

No publications provided

Responsible Party: William (Bill) Whitehead, PhD, Professor of Medicine and Adjunct Professor of OBGYN, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01717456     History of Changes
Other Study ID Numbers: 11-1569, R01HS018695
Study First Received: September 15, 2012
Last Updated: November 8, 2013
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by University of North Carolina, Chapel Hill:
Fecal incontinence
Frail elders
Home health care
Nurse
Patient education

Additional relevant MeSH terms:
Fecal Incontinence
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Antidiarrheals
Loperamide
Laxatives
Cathartics
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014