The Effect of CIC Education on QOL and Compliance With Mobile Application in Individuals With Spinal Cord Injury.

Spinal Cord Injury Clinical Trial

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)

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06429631
• Other study ID #: 77082166-302.08.01-424987
• Status: Enrolling by invitation
• Phase: N/A
• Start date: September 15, 2023
• Est. completion date: August 31, 2024

Study information

• Verified date: May 2024
• Source: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 Catheterization(CIC) 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 IC(Intermittent 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.

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-BREF(World Health Organization Quality of Life Scale):The 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 questions:yes = 1, no = 0, whereas the response options for the eighth question were graded on a 5-point Likert-type scale: 0 indicating "never," 0.25 "sometimes," 0.5 "often,"0.75 "regularly," and 1 "always," leading to a maximum possible score of 8. A patient's 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 constructs/factors which includes four items each (40 items at total). The scale measures using a 7-point Likert-type scale (1=strongly disagree…7=strongly agree)

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 42
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• spinal cord injury patients,

• The doctor has decided that the patient should undergo intermittent catheterization

• Having received CIC training within the last month,

• Having a phone with IOS/Android features,

• Sending the surveys in the 12th week, the participants must be using the WhatsApp application to send the surveys.

• being able to communicate,

• sufficient manual dexterity,

• having a body mass index below 30,

• no vision problems,

• turkish speech,

• using single-use catheter

Exclusion Criteria:

• Having received IC training more than 1 month ago,

• Individuals in the experimental group did not use the mobile application,

• incompletely filled out forms,

Related Conditions & MeSH terms

• Intermittent Catheterization
• Mobile Application
• Neurogenic Bladder
• Spinal Cord Injuries
• Spinal Cord Injury
• Urinary Bladder, Neurogenic
• Wounds and Injuries

Intervention

Device:
• mobile application on telephone
when patient discharge from the hospital, mobile application downloaded their telephone. then researcher give feedback about patients CIC outputs. also mobile application include 2 animations, videos, "frequently asked questions" and "ask the expert" section.

Locations

Country	Name	City	State
Turkey	Ankara Gaziler Physical Therapy and Rehabilitation Training and Research Hospital	Ankara	Çankaya
Turkey	Ankara Gaziler Physical Therapy and Rehabilitation Training and Research Hospital	Ankara	Çankaya

Sponsors (2)

Lead Sponsor	Collaborator
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital	Gazi University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mobile Application Usability Scale (MAUS)	The scale measures mobile application usability which is formed with 10 constructs/factors which includes four items each (40 items at total). The scale measures using a 7-point Likert-type scale (1=strongly disagree…7=strongly agree)	Only the experimental group completes this scale 12 weeks after discharge.
Primary	1. WHOQOL-BREF(World Health Organization Quality of Life questionnaire),	This study want to evaluate quality of life with 2 scales. WHOQOL-BREF(World Health Organization Quality of Life Scale):The 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. Turkish version is 27 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.	Patients fill the scale "before discharge" and 12 weeks after discharge.
Primary	2. 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.	Patients fill the scale "before discharge" and 12 weeks after discharge.
Secondary	Intermittent Catheterization Adherence Scale (ICAS)	This study want to evaluate compliance with one scale. ICAS (IntermittentCatheterization Adherence Scale) is used to assess long-term patient adherence to prescribed ISC treatment. Binary answers were used for the first seven questions:yes = 1, no = 0, whereas the response options for the eighth question were graded on a 5-point Likert-type scale: 0 indicating "never," 0.25 "sometimes," 0.5 "often,"0.75 "regularly," and 1 "always," leading to a maximum possible score of 8. A patient's score is empirically classified in to three intervals: strong adherence = 0; average adherence = 1-2; low adherence = 3-8.	Patients fill the scale "before discharge" and 12 weeks after discharge.