An interventional study of Web-based education in Noninvasive Ventilation and COPD, sponsored by KTO Karatay University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-02.
Sponsored by KTO Karatay University · Not applicable, Interventional, and Health services research
Home use of the NIV device, which is used to manage respiratory failure, one of the most disturbing symptoms due to COPD, will continue to increase. There is a need for studies evaluating the effectiveness of the use of WEB-based training programs in making patients and their families independent in the use of this device. This study will produce evidence for this effect and contribute to the awareness of healthcare professionals working in this field. The WEB-based training module to be developed aims to increase compliance with NIV in patients using NIV at home for a long time and to manage symptoms such as insomnia that may develop due to NIV.
Support will be received from a software expert in mobile application development. The Mobile Application will be given the short name "Breathe", which indicates that it is an application application. The mobile application is planned to consist of 7 interfaces. 1.Interface: Training on Living with NIV - Password and Information General information about Living with NIV Training will be included. It is an interface where individuals can log in to the system with their password and information.
2.Interface: What is BIPAP? This interface will include general information about individuals' intended use of NIV, what it does, and how to select equipment.
3.Interface: Maintenance and cleaning of the device This interface will contain information on when and how the NIV device and equipment should be cleaned.
4.Interface: Most frequently asked questions about BIPAP treatment This interface will include the problems that individuals frequently experience when using NIV and tips on how to solve these problems.
Interface 5: Insomnia and coping methods This interface will contain information about insomnia and what techniques to use to cope with insomnia. It will also include sleep exercise to help you fall asleep.
6.Interface: Trainings This interface; It will consist of educational content such as breathing exercise, lung cleaning technique, breathing control in daily life activities (walking, bathing, climbing stairs, etc.), personal hygiene and dressing, and communication and special situations while using NIV.
7.Interface: Communication It is an interface where individuals can communicate with the researcher and ask questions.
Individuals assigned to the experimental group Individuals in the experimental group will be informed about the mobile application. The web-based mobile application called "Training for Living with NIV" prepared by the researcher will be installed on the mobile phone of the individual or his caregiver. They will be asked to log in to the web-based "NIV Living Training" mobile application once a week to consolidate their knowledge, and text message alerts will be sent via mobile phone. S³-NIV Questionnaire and ISI forms will be applied to the experimental group again in the first week, 4th week and 8th week.
Individuals assigned to the control group Written educational material was sent to individuals in the control group. S³-NIV Questionnaire and ISI forms will be applied again to the control group in the first week, 4th week and 8th week. After the 8th week data collection, web-based "NIV Survival Training" will also be given to individuals in the control group.
4,131 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 697 are open to participants now.
This study's enrollment of 80 is above the median of 70 across 2,926 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →KTO Karatay University is the lead sponsor of 126 studies on the registry; 16 are open to participants now.
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Individuals in the experimental group will be informed about the mobile application. The web-based mobile application called "Training for Living with NIV" prepared by the researcher will be installed on the mobile phone of the individual or his caregiver. They will be asked to log in to the web-based "NIV Living Training" mobile application twice a week to reinforce their knowledge, and text message alerts will be sent via mobile phone. Patient Descriptive Characteristics Form, S³-NIV Questionnaire and Insomnia Severity Index scales will be applied to the experimental group as pre-test data. The scales will be applied again to the experimental group, which continues education for 8 weeks, in the 4th week and the 8th week.
Behavioral: Web-based education
Written educational material was sent to individuals in the control group. Patient Descriptive Characteristics Form, S³-NIV Questionnaire and Insomnia Severity Index scales will be applied as pre-test data to the control group, which is not given any training other than written material. During the 8-week period, the scales will be applied to the control group again in the 4th week and the 8th week. After the 8th week data collection, web-based "NIV Survival Training" will also be given to individuals in the control group.
Patients using noninvasive ventilation at home will receive detailed information about accessing, logging in and using web-based training. Pretest data will be collected, then week 4 and week 8 data will be collected.
S³-NIV Questionnaire Total Score
Description: The questionnaire was developed to evaluate noninvasive ventilation at home. The survey consists of 10 items and two sub-dimensions. A five-point Likert scale is used to rate the items: always yes (0), mostly yes (1), sometimes yes (2), mostly no (3), completely no (4). The Cronbach alpha reliability coefficient of the survey was found to be 0.77. Score of the survey total and sub-dimensions; It is obtained by taking the average of the total score of the items and multiplying the result by 2.5. The lowest possible score (0) corresponds to the highest impact of disease and treatment, while the highest possible score (10) corresponds to the lowest impact of disease and treatment.
Time frame: Baseline, Week 4, and Week 8
Insomnia Severity Index (ISI) Total Score
This scale is used for routine screening and the clinical assessment of insomnia to identify sleep disturbances. It consists of seven items and two sub-dimensions. It is a 5-point Likert-type scale where each item is scored from 0 to 4, resulting in a total score ranging from 0 to 28. Scores of 0-7 indicate subclinical insomnia, 8-14 indicate mild insomnia, 15-21 indicate moderate insomnia, and 22-28 indicate severe insomnia. The scale's internal consistency is 0.79.
Time frame: Baseline, Week 4, and Week 8
S³-NIV Respiratory Symptoms Subscale Score
Evaluated using the Respiratory Symptoms subscale of the S³-NIV Questionnaire. This subscale comprises 4 items (items 1, 4, 5, and 6) rated on a 5-point Likert scale ranging from 0 (always yes) to 4 (completely no). The total score ranges from 0 to 16 points. Lower scores indicate more severe respiratory symptoms, while higher scores reflect fewer respiratory symptoms and better patient adaptation to noninvasive ventilation (NIV) use.
Time frame: Baseline, Week 4, and Week 8
S³-NIV Sleep/NIV-Related Side Effects Subscale Score
Evaluated using the Sleep and NIV-Related Side Effects subscale of the S³-NIV Questionnaire. This subscale comprises 6 items (items 2, 3, 7, 8, 9, and 10) rated on a 5-point Likert scale ranging from 0 (always yes) to 4 (completely no). The total score ranges from 0 to 24 points. Lower scores indicate more severe side effects and sleep disturbances related to ventilation, while higher scores reflect fewer symptoms and better adaptation to home NIV treatment.
Time frame: Baseline, Week 4, and Week 8
Plan to share: No — The data will be collected by the researcher at the University of Health Sciences Konya Beyhekim Training and Research Hospital.
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Pulmonary Disease, Chronic Obstructive→
KTO Karatay University