Viewing Study NCT06429631



Ignite Creation Date: 2024-06-16 @ 11:48 AM
Last Modification Date: 2024-10-26 @ 3:30 PM
Study NCT ID: NCT06429631
Status: ENROLLING_BY_INVITATION
Last Update Posted: 2024-05-28
First Post: 2024-05-18

Brief Title: The Effect of CIC Education on QOL and Compliance With Mobile Application in Individuals With Spinal Cord Injury
Sponsor: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Organization: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Study Overview

Official Title: The Effect of CIC Education on Quality of Life and Compliance With Mobile Application After Discharge in Individuals With Spinal Cord Injury CIC Clean Intermittent Catheterization
Status: ENROLLING_BY_INVITATION
Status Verified Date: 2024-05
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Neurogenic bladder is a condition that occurs due to nerve damage or congenital problems and causes urination disorders Nowadays in individuals diagnosed with neurogenic bladder Clean Intermittent Catheterization is often used to evacuate the urine accumulated in the bladder Clean Intermittent CatheterizationCIC is a simple safe and effective method in which the catheter is placed through the meatus In this application the catheter is removed without waiting after urine drainage is achieved This process is usually performed on its own Since ICIntermittent Catheterization is a procedure performed on the bladder it may cause some complications IC application must be performed successfully to prevent or reduce complications The success of the technique largely depends on patient education and follow-up Sometimes patients may not be able to come to the hospital for follow-up and feedback after IC training

Innovations are needed to ensure the continuation of distance education so that the education of patients who cannot come to the hospital is not incomplete The literature includes brochures videos websites and some mobile applications for IC training However no application has been found that monitors patients urine amounts

This research was planned to examine the effect of clean intermittent catheterization training given via mobile application to individuals with spinal cord injury on their quality of life and compliance
Detailed Description: scales

1 Information form Authors will ask to patients age weight height gender marital status education level diagnosis time of injury cause of injury independence level working or not working presence of spasticity presence of complications
2 WHOQOL-BREFWorld Health Organization Quality of Life ScaleThe WHO Quality of Life Assessment WHOQOL is a generic quality of life instrument that was designed to be applicable to people living under different circumstances conditions and cultures The short version known as WHOQOL-BREF with 26 items It is based on a Likert-type scale and is scored from 1 to 5 with higher scores indicating a better quality of life
3 Intermittent Self-Catheterization Questionnaire ISC-Q This is a 24-item self-administered questionnaire Each item is scored on a 5-point Likert-type scale ranging from 0 strongly disagree to 4 strongly agree and after the conversion of the 14 reverse-coded items to give a common range of 0-100 the scores are calculated by multiplying the mean value of all items within each domain by 25 The total ISC-Q score is then calculated from the simple average from across the four domains 0-100 with higher scores indicating a higher quality of life
4 Intermittent Catheterization Adherence Scale ICAS ICAS IntermittentCatheterization Adherence Scale is used to assess long-term patient adherence to prescribed ISC treatment Binary answers were used for the first seven questionsyes 1 no 0 whereas the response options for the eighth question were graded on a 5-point Likert-type scale 0 indicating never 025 sometimes 05 often075 regularly and 1 always leading to a maximum possible score of 8 A patients score is empirically classified into three intervals strong adherence 0 average adherence 1-2 low adherence 3-8
5 Mobile Application Usability Scale MAUS The scale measures mobile application usability which is formed with 10 constructsfactors which includes four items each 40 items at total The scale measures using a 7-point Likert-type scale 1strongly disagree7strongly agree

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None