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

NCT06429631 | Completed DMC

• 1 other identifier: 77082166-302.08.01-424987
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 2

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.

Conditions

Neurogenic Bladder; Spinal Cord Injury; Intermittent Catheterization; Mobile Application

Keywords

neurogenic bladder; education; mobil application; compliance; quality of life

Outcome Measures

Primary Outcomes (2)

• 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.

• 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 Outcomes (1)

• Intermittent Catheterization Adherence Scale (ICAS)

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

Other Outcomes (1)

• Mobile Application Usability Scale (MAUS)

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

Study Arms (2)

control group(routine CIC education)

NO INTERVENTION

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

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

EXPERIMENTAL

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.

Device: mobile application on telephone

Interventions

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.

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Gaziler Physical Medicine and Rehabilitation Education and Research Hospital: lead
• Gazi University: collaborator

Study Sites (2)

Ankara Gaziler Physical Therapy and Rehabilitation Training and Research Hospital

Ankara, Çankaya, 0000000, Turkey (Türkiye)

Location

Ankara Gaziler Physical Therapy and Rehabilitation Training and Research Hospital

Ankara, Çankaya, 680000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Urinary Bladder, Neurogenic; Spinal Cord Injuries; Patient Compliance

Condition Hierarchy (Ancestors)

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

Study Officials

• NURCAN ÇALIŞKAN, Prof. Dr

  Gazi University

  PRINCIPAL INVESTIGATOR

• BİLGE YILMAZ, Prof. Dr.

  SBÜ GAZİLER FİZİK TEDAVİ VE REHABİLİTASYON EĞİTİM VE ARAŞTIRMA HASTANESİ

  PRINCIPAL INVESTIGATOR

• Nilgün Aras, Phd student

  SBÜ GAZİLER FİZİK TEDAVİ VE REHABİLİTASYON EĞİTİM VE ARAŞTIRMA HASTANESİ

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The person doing the statistical analysis will not know which is the experiment and which is the control group.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nurse, RN, MSN, Phd

Model Details: parallel group single-blind randomized control trial

Study Record Dates

• First Submitted: May 18, 2024
• First Posted: May 28, 2024
• Study Start: August 1, 2023
• Primary Completion: August 15, 2024
• Study Completion: November 15, 2024
• Last Updated: March 6, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)