Fecal incontinence (FI), affects 9% of non-institutionalized U.S. adults (15% of those over age 70). Frequent or large volume FI often leads to emotional distress, social isolation and job loss, and increases the likelihood of admission to a nursing home. Effective treatments are available in the form of biofeedback and sacral nerve stimulation, but these are expensive and not widely available. Moreover, more than 70% of patients with FI do not report it to a physician but attempt to manage on their own. Our team has developed a conservative treatment protocol involving patient education, pelvic floor exercises, and normalization of stool consistency with fiber or medication which reduces FI episode frequency by 60-80% and enables as many as 66% of patients to become continent. This degree of improvement may be enough to enable most patients to remain independent.
Aims : Our long-term goal is to develop a self-management website based on this conservative treatment protocol which persons with FI can use as an adjunct to medical management. The following modifications are needed to change the current nurse-led treatment protocol into an effective self-management tool: (1) Redesign the patient education component into 15-20 minute modules followed by quizzes and retraining to insure mastery. (2) Develop an interactive patient diary which adjusts treatment targets based on the frequency of accidents and consistency of stools during the previous week, with graphical feedback of training progress and symptom change. (3) Develop a bank of frequently asked questions with answers. (4) Design the website so that family caregivers can assist patients with cognitive deficits or other disabilities to adhere to the treatment program.
The aims of this R21 application are (a) to design the website to address the 4 subgoals listed above, and (b) to collect preliminary outcome data which will be used to design a randomized controlled trial (future R01). Methods: To address the first aim, small groups of 6-10 FI patients recruited from informational websites including www.aboutincontinence.org, www.med.unc.edu IBS and from physician referrals will be asked to complete each educational module and to rate on a 0-10 scale the understandability of instructions, performance difficulty, and relevance of the website content. The process will be iterative such that, when a small group completes an educational module, the website will be modified based on their ratings, and new groups will be asked to test the modified website content until the average rating of understandability and relevance are >7/10 and their rating of difficulty is <3/10 for each educational module and for the interactive diary.
Aim 2 will be addressed by recruiting a new group of 60 FI patients in North Carolina and Virginia who will complete the self-management protocol. We will evaluate FI frequency, FI severity and FI quality of life before and after treatment, and will ask these patients to provide feedback on the understandability, difficulty, and relevance of the program.

Public Health Relevance

Fecal incontinence affects 9% of non-institutionalized U.S. adults (15% of those over age 70) and contributes to impaired quality of life, emotional distress, social isolation, and increased likelihood of admission to a nursing home. Fewer than 10% of affected patients receive medical diagnosis and treatment, and effective treatments are expensive and not widely available. Moreover, more than 70% of patients with FI do not report this to a physician but attempt to manage on their own. This study will test whether a conservative treatment protocol that yields 80% reductions in the frequency of fecal incontinence in laboratory studies will work equally well when disseminated through a self-management website which persons with FI can use for education toward self-treatment or as an adjunct to medical management.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Exploratory/Developmental Grants (R21)
Project #
1R21DK096545-01A1
Application #
8637226
Study Section
Behavioral Medicine, Interventions and Outcomes Study Section (BMIO)
Program Officer
Hamilton, Frank A
Project Start
2013-09-19
Project End
2015-08-31
Budget Start
2013-09-19
Budget End
2014-08-31
Support Year
1
Fiscal Year
2013
Total Cost
$228,000
Indirect Cost
$78,000
Name
University of North Carolina Chapel Hill
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
608195277
City
Chapel Hill
State
NC
Country
United States
Zip Code
27599