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Standard Versus Mnemonic Counseling for Fecal Incontinence (FIT)

This study is currently recruiting participants.
Verified January 2013 by University of New Mexico
Sponsor:
Information provided by (Responsible Party):
Sara Cichowski, University of New Mexico
ClinicalTrials.gov Identifier:
NCT01778660
First received: January 16, 2013
Last updated: February 21, 2013
Last verified: January 2013
History of Changes

January 16, 2013
February 21, 2013
February 2013
December 2013   (final data collection date for primary outcome measure)
Recall [ Time Frame: We are measuring the difference in recall the day of the physician counseling and 2 months after physician counselling ] [ Designated as safety issue: No ]
Patients will be asked to recall treatments recommended for fecal incontinence.
Same as current
Complete list of historical versions of study NCT01778660 on ClinicalTrials.gov Archive Site
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Standard Versus Mnemonic Counseling for Fecal Incontinence
Standard Versus Mnemonic Counseling for Fecal Incontinence: a Pilot Randomised Control Trial

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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Fecal Incontinence
  • Counselling
  • Patient Satisfaction
  • Other: Type of Counselling (Mnemonic)
  • Other: Standard
  • Active Comparator: Standard Counselling
    Patients in this arm are randomised to standard counselling.
    Intervention: Other: Standard
  • Experimental: Mnemonic Counselling
    Patients in this arm are randomised to counselling with the aid of a mnemonic.
    Intervention: Other: Type of Counselling (Mnemonic)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
90
May 2014
December 2013   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact: Sara Cichowski, M.D. 505 272 6337 scichowski@salud.unm.edui
Contact: Gena Dunivan, M.D. 505 272 6337 gdunivan@salud.unm.edu
United States
 
NCT01778660
CTSC-12-429, CTSTC025-3
No
Sara Cichowski, University of New Mexico
University of New Mexico
Not Provided
Principal Investigator: Sara Cichowski, M.D. University of New Mexico
University of New Mexico
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP