## Protocol Section
### Identification Module
**NCT ID:** NCT06429631

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

**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)

#### Organization Study ID Info
**ID:** 77082166-302.08.01-424987
#### Organization
**Class:** OTHER
**Full Name:** Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
### Status Module
#### Completion Date
**Date:** 2024-08-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-23

**Overall Status:** ENROLLING_BY_INVITATION

#### Primary Completion Date
**Date:** 2024-08-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2023-09-15

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-18
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Gazi University

#### Lead Sponsor

**Class:** OTHER

**Name:** Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

#### Responsible Party

**Investigator Affiliation:** Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

**Investigator Full Name:** Nilgün Aras

**Investigator Title:** Nurse, MSN

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**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 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.

**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-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)

### Conditions Module

**Conditions:**

- Neurogenic Bladder

- Spinal Cord Injury

- Intermittent Catheterization

- Mobile Application

**Keywords:**

- neurogenic bladder

- education

- mobil application

- compliance

- quality of life

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** parallel group single-blind randomized control trial

##### Masking Info

**Masking:** SINGLE

**Masking Description:** The person doing the statistical analysis will not know which is the experiment and which is the control group.

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** SUPPORTIVE_CARE

#### Enrollment Info

**Count:** 42

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** This group has routine CIC education. They fill the scales before discharge and 12. week after discharge.

**Label:** control group(routine CIC education)

**Type:** NO_INTERVENTION

#### Arm Group 2

**Description:** This group has routine CIC education. Also mobile application uploaded their telephone before discharge.

They fill the scales before discharge and 12. week after discharge.

**Intervention Names:**

- Device: mobile application on telephone

**Label:** experimental group(routine CIC education+mobile application on telephone)

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- experimental group(routine CIC education+mobile application on telephone)

**Description:** 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.

**Name:** mobile application on telephone

**Type:** DEVICE

### Outcomes Module

#### Other Outcomes

**Description:** 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)

**Measure:** Mobile Application Usability Scale (MAUS)

**Time Frame:** Only the experimental group completes this scale 12 weeks after discharge.

#### Primary Outcomes

**Description:** 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.

**Measure:** 1. WHOQOL-BREF(World Health Organization Quality of Life questionnaire),

**Time Frame:** Patients fill the scale "before discharge" and 12 weeks after discharge.

**Description:** 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.

**Measure:** 2. Intermittent Self-Catheterization Questionnaire (ISC-Q)

**Time Frame:** Patients fill the scale "before discharge" and 12 weeks after discharge.

#### Secondary Outcomes

**Description:** 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.

**Measure:** Intermittent Catheterization Adherence Scale (ICAS)

**Time Frame:** Patients fill the scale "before discharge" and 12 weeks after discharge.

### Eligibility Module

**Eligibility Criteria:** 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,

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Ankara

**Country:** Turkey

**Facility:** Ankara Gaziler Physical Therapy and Rehabilitation Training and Research Hospital

**State:** Çankaya

**Zip:** 0000000

**Location 2:**

**City:** Ankara

**Country:** Turkey

**Facility:** Ankara Gaziler Physical Therapy and Rehabilitation Training and Research Hospital

**State:** Çankaya

**Zip:** 680000

#### Overall Officials

**Official 1:**

**Affiliation:** Gazi University

**Name:** NURCAN ÇALIŞKAN, Prof. Dr

**Role:** PRINCIPAL_INVESTIGATOR

**Official 2:**

**Affiliation:** SBÜ GAZİLER FİZİK TEDAVİ VE REHABİLİTASYON EĞİTİM VE ARAŞTIRMA HASTANESİ

**Name:** BİLGE YILMAZ, Prof. Dr.

**Role:** PRINCIPAL_INVESTIGATOR

**Official 3:**

**Affiliation:** SBÜ GAZİLER FİZİK TEDAVİ VE REHABİLİTASYON EĞİTİM VE ARAŞTIRMA HASTANESİ

**Name:** Nilgün Aras, Phd student

**Role:** STUDY_CHAIR

### IPD Sharing Statement Module

**Description:** Since the study is still not finished, it was decided not to share it.

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000013118

- Term: Spinal Cord Diseases

- ID: D000002493

- Term: Central Nervous System Diseases

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000020196

- Term: Trauma, Nervous System

- ID: D000009461

- Term: Neurologic Manifestations

- ID: D000001745

- Term: Urinary Bladder Diseases

- ID: D000014570

- Term: Urologic Diseases

- ID: D000052776

- Term: Female Urogenital Diseases

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000052801

- Term: Male Urogenital Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC26

- Name: Wounds and Injuries

- Abbrev: All

- Name: All Conditions

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

### Condition Browse Module - Browse Leaves

- ID: M15916

- Name: Spinal Cord Injuries

- Relevance: HIGH

- As Found: Spinal Cord Injury

- ID: M5031

- Name: Urinary Bladder, Neurogenic

- Relevance: HIGH

- As Found: Neurogenic Bladder

- ID: M17685

- Name: Wounds and Injuries

- Relevance: HIGH

- As Found: Injury

- ID: M15915

- Name: Spinal Cord Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5742

- Name: Central Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M22023

- Name: Trauma, Nervous System

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: M5026

- Name: Urinary Bladder Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17319

- Name: Urologic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M27095

- Name: Male Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T6034

- Name: Quality of Life

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000013119

- Term: Spinal Cord Injuries

- ID: D000001750

- Term: Urinary Bladder, Neurogenic

- ID: D000014947

- Term: Wounds and Injuries

### Misc Info Module

- Version Holder: 2024-05-31
