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NCT Number: NCT06429631

The Effects of CIC Training With a Mobile Application on Quality of Life and Compliance in Spinal Cord Injury Patients: a Single Blind Randomized Controlled Study

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.

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Key information

Conditions

Neurogenic Bladder Behavior Central Nervous System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Health Behavior Intermittent Catheterization Male Urogenital Diseases Mobile Application Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Patient Acceptance of Health Care Patient Compliance Signs and Symptoms Spinal Cord Diseases Spinal Cord Injuries Spinal Cord Injury Trauma, Nervous System Treatment Adherence and Compliance Urinary Bladder Diseases Urinary Bladder, Neurogenic Urogenital Diseases Urologic Diseases Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ankara Gaziler Physical Therapy and Rehabilitation Training and Research Hospital, Ankara, Çankaya, Turkey (Türkiye)

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About this study

scales:

  • 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
  • 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 27 itemsin Turkish version. It is based on a Likert-type scale and is scored from 1 to 5, with higher scores indicating a better quality of life.
  • 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.
  • 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.
  • 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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

The study inclusion criteria were (1) 18-65 years of age, (2) receiving CIC training for the first time, (3) having sufficient manual dexterity, (4) using a single-use hydrophilic catheter, (5) having an IOS/Android phone and internet access, (6) having no vision problems, (7) having a Body Mass Index (BMI) <30, (8) speaking Turkish.

Participants were excluded if (1) they wanted to withdraw from the study, (2) they did not complete the data collection forms, (3) the doctor decided they should stop CIC, (4) they did not use the mobile application in the intervention group, and (5) they had received CIC training more than one month ago.

Treatment and study plan

mobile application on telephone

Device

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.

Primary outcomes

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

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

    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.

  2. 2. Intermittent Self-Catheterization Questionnaire (ISC-Q)

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

    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.

Secondary outcomes

  1. Intermittent Catheterization Adherence Scale (ICAS)

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

    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.

Other outcomes

  1. Mobile Application Usability Scale (MAUS)

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

    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)

Sponsors and collaborators

Lead sponsor

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Other

Collaborators

  • Gazi University

Registry information

Official study title

The Effects of CIC Training With a Mobile Application on Quality of Life and Compliance in Spinal Cord Injury Patients: a Single Blind Randomized Controlled Study (CIC: Clean Intermittent Catheterization)

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 28, 2024
Registry last updated
Mar 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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