Back to resultsStandard Versus Mnemonic Counseling for Fecal Incontinence (FIT)
Primary Purpose
Fecal Incontinence, Counselling, Patient Satisfaction
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Type of Counselling (Mnemonic)
Standard
Sponsored by
About this trial
This is an interventional treatment trial for Fecal Incontinence focused on measuring Fecal Incontinence, Treatment options, Patient Satisfaction
Eligibility Criteria
Inclusion Criteria:
- Over 18 years of age
- Diagnosed with fecal incontinence by on of the attending physicians
- Bothersome fecal incontinence symptoms for at least 3 months
- Able to give informed consent
- Able to speak, read and comprehend English
Exclusion Criteria:
- Younger than 18 years
- Fecal Incontinence <3 months
- Unable to give informed consent
- Unable to speak, read and comprehend English
- Diagnosis of active colorectal or anal malignancy, inflammatory bowel disease, recto-vaginal fistula, and rectal prolapse
Sites / Locations
- University of New Mexico
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Standard Counselling
Mnemonic Counselling
Arm Description
Patients in this arm are randomised to standard counselling.
Patients in this arm are randomised to counselling with the aid of a mnemonic.
Outcomes
Primary Outcome Measures
Recall
Patients will be asked to recall treatments recommended for fecal incontinence.
Secondary Outcome Measures
Questionare on the Quality of the Physician and Patient Interaction
Modified Manchester
Full Information
NCT ID
NCT01778660
First Posted
January 16, 2013
Last Updated
April 4, 2014
Sponsor
University of New Mexico
1. Study Identification
Unique Protocol Identification Number
NCT01778660
Brief Title
Standard Versus Mnemonic Counseling for Fecal Incontinence
Acronym
FIT
Official Title
Standard Versus Mnemonic Counseling for Fecal Incontinence: a Pilot Randomised Control Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of New Mexico
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study compares standard versus mnemonic counseling for the treatment of fecal incontinence. A mnemonic is a word or rhyme used to aid memory. Our hypothesis is that women randomised to mnemonic counseling will higher recall of treatments, satisfaction with the physician visit and greater improvement in their quality of life when compared to women who received standard counseling.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fecal Incontinence, Counselling, Patient Satisfaction
Keywords
Fecal Incontinence, Treatment options, Patient Satisfaction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard Counselling
Arm Type
Active Comparator
Arm Description
Patients in this arm are randomised to standard counselling.
Arm Title
Mnemonic Counselling
Arm Type
Experimental
Arm Description
Patients in this arm are randomised to counselling with the aid of a mnemonic.
Intervention Type
Other
Intervention Name(s)
Type of Counselling (Mnemonic)
Intervention Type
Other
Intervention Name(s)
Standard
Primary Outcome Measure Information:
Title
Recall
Description
Patients will be asked to recall treatments recommended for fecal incontinence.
Time Frame
We are measuring the difference in recall the day of the physician counseling and 2 months after physician counselling
Secondary Outcome Measure Information:
Title
Questionare on the Quality of the Physician and Patient Interaction
Time Frame
Patients will complete this questionnaire following the physician counseling on day 1 of enrollment.
Title
Modified Manchester
Time Frame
We are comparing the score change from after the physician counselling on day 1 of enrollment and at 2 month follow-up.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Over 18 years of age
Diagnosed with fecal incontinence by on of the attending physicians
Bothersome fecal incontinence symptoms for at least 3 months
Able to give informed consent
Able to speak, read and comprehend English
Exclusion Criteria:
Younger than 18 years
Fecal Incontinence <3 months
Unable to give informed consent
Unable to speak, read and comprehend English
Diagnosis of active colorectal or anal malignancy, inflammatory bowel disease, recto-vaginal fistula, and rectal prolapse
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sara Cichowski, M.D.
Organizational Affiliation
University of New Mexico
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of New Mexico
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
25932833
Citation
Cichowski SB, Dunivan GC, Rogers RG, Murrietta AM, Komesu YM. Standard compared with mnemonic counseling for fecal incontinence: a randomized controlled trial. Obstet Gynecol. 2015 May;125(5):1063-1070. doi: 10.1097/AOG.0000000000000755.
Results Reference
derived
Learn more about this trial
Standard Versus Mnemonic Counseling for Fecal Incontinence
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