Standard Versus Mnemonic Counseling for Fecal Incontinence

Patient Satisfaction Clinical Trial

— FIT  

Official title:

Standard Versus Mnemonic Counseling for Fecal Incontinence: a Pilot Randomised Control Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01778660
• Other study ID #: CTSC-12-429
• Secondary ID: CTSTC025-3
• Status: Completed
• Phase: N/A
• First received: January 16, 2013
• Last updated: April 4, 2014
• Start date: February 2013
• Est. completion date: February 2014

Study information

• Verified date: January 2013
• Source: University of New Mexico
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Clinical and Translational Sciences Center University of New Mexico
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Counselling
• Fecal Incontinence
• Patient Satisfaction

Intervention

Other:
• Type of Counselling (Mnemonic)

• Standard

Locations

Country	Name	City	State
United States	University of New Mexico	Albuquerque	New Mexico

Sponsors (1)

Lead Sponsor	Collaborator
University of New Mexico

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recall	Patients will be asked to recall treatments recommended for fecal incontinence.	We are measuring the difference in recall the day of the physician counseling and 2 months after physician counselling	No
Secondary	Questionare on the Quality of the Physician and Patient Interaction		Patients will complete this questionnaire following the physician counseling on day 1 of enrollment.	No
Secondary	Modified Manchester		We are comparing the score change from after the physician counselling on day 1 of enrollment and at 2 month follow-up.	No