Intermittent Catheterization Acceptance Test (I-CAT)
|ClinicalTrials.gov Identifier: NCT01651546|
Recruitment Status : Completed
First Posted : July 27, 2012
Last Update Posted : June 15, 2015
The aim of the study is to create and validate a specific test named Intermittent Catheterization Acceptance Test (I-CAT), assessing "the acceptance" of clean intermittent self catheterization (CISC) in a neurological and no neurological population with indication to self catheterization.
CISC avoids urological complications in bladder with chronic and improves quality of life. Despite theses challenges, the learning of CISC can face some physical, cognitive and psychological difficulties. Recently, we have validate a new test for predicting the physical and cognitive abilities to practice CISC named "PP-Test". Meanwhile, psychological factors are not explored in this test. To our knowledge, no study has been conducted in order to demonstrate in a prospective trial, which kind of psychological barriers can exist. Likewise it would be interesting to create a new test assessing the psychological "acceptance" of the patients to CISC before learning (I-CAT). Based on the results of this self-assessment test, the specific nurse could then change her speech by playing down the importance of some fear and anxiety described by the patients. The learning of CISC would be facilitated.
|Condition or disease||Intervention/treatment||Phase|
|Intermittent Self Catheterization||Behavioral: Intermittent catheterization test||Not Applicable|
The first version of the questionnaire (I-CAT) has already been elaborated from some neuro-urology experts and patients's comments.
The final version will be validated after a feasibility study. The psychometric criteria will be validated.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Development and Psychometric Validation of a Scale Assessing "the Acceptance" of Clean Intermittent Self Catheterization in a Neurological and no Neurological Population With Indication to Self Catheterization.|
|Study Start Date :||March 2013|
|Actual Primary Completion Date :||March 2015|
|Actual Study Completion Date :||March 2015|
Patients with dysvoiding function and chronic urinary retention, with an indication to CISC.
Behavioral: Intermittent catheterization test
I-CAT will be a self assessment questionnaire and a simple, comprehensive and quickly passed questionnaire.
- Intermittent catheterization acceptance test (I-CAT) [ Time Frame: 2 years ]
In order to validate the questionnaire, the patients will have to respond to I-CAT at 3 times:
- the day the CISC's indication is decided
- at the learning'CISC consultation about 8 days later
- during the verification's CISC consultation about 15 days later
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01651546
|Paris, France, 75012|
|Principal Investigator:||Gérard Amarenco, PU/PH||Assistance Publique|