Standard Versus Mnemonic Counseling for Fecal Incontinence (FIT)

April 4, 2014 updated by: Sara Cichowski, University of New Mexico

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
        • University of New Mexico

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recall
Time Frame: We are measuring the difference in recall the day of the physician counseling and 2 months after physician counselling
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

Secondary Outcome Measures

Outcome Measure
Time Frame
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.
Patients will complete this questionnaire following the physician counseling on day 1 of enrollment.
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.
We are comparing the score change from after the physician counselling on day 1 of enrollment and at 2 month follow-up.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of New Mexico

Investigators

  • Principal Investigator: Sara Cichowski, M.D., University of New Mexico

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

January 16, 2013

First Submitted That Met QC Criteria

January 28, 2013

First Posted (Estimate)

January 29, 2013

Study Record Updates

Last Update Posted (Estimate)

April 8, 2014

Last Update Submitted That Met QC Criteria

April 4, 2014

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTSC-12-429
  • CTSTC025-3 (Other Identifier: CTSC)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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