Standard Versus Mnemonic Counseling for Fecal Incontinence (FIT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sara Cichowski, University of New Mexico
ClinicalTrials.gov Identifier:
NCT01778660
First received: January 16, 2013
Last updated: April 4, 2014
Last verified: January 2013
  Purpose

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.


Condition Intervention
Fecal Incontinence
Counselling
Patient Satisfaction
Other: Type of Counselling (Mnemonic)
Other: Standard

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Standard Versus Mnemonic Counseling for Fecal Incontinence: a Pilot Randomised Control Trial

Resource links provided by NLM:


Further study details as provided by University of New Mexico:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Enrollment: 90
Study Start Date: February 2013
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard Counselling
Patients in this arm are randomised to standard counselling.
Other: Standard
Experimental: Mnemonic Counselling
Patients in this arm are randomised to counselling with the aid of a mnemonic.
Other: Type of Counselling (Mnemonic)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  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: NCT01778660

Locations
United States, New Mexico
University of New Mexico
Albuquerque, New Mexico, United States, 87131
Sponsors and Collaborators
University of New Mexico
Investigators
Principal Investigator: Sara Cichowski, M.D. University of New Mexico
  More Information

No publications provided

Responsible Party: Sara Cichowski, Principal Investigator, University of New Mexico
ClinicalTrials.gov Identifier: NCT01778660     History of Changes
Other Study ID Numbers: CTSC-12-429, CTSTC025-3
Study First Received: January 16, 2013
Last Updated: April 4, 2014
Health Authority: United States: Clinical and Translational Sciences Center University of New Mexico

Keywords provided by University of New Mexico:
Fecal Incontinence
Treatment options
Patient Satisfaction

Additional relevant MeSH terms:
Fecal Incontinence
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on September 16, 2014