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Completed

NCT Number: NCT06343324

Effect of Web-Based Adaptation and Insomnia Severity in Individuals Using Noninvasive Ventilators at Home

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.

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Key information

Conditions

Noninvasive Ventilation COPD Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Microcephaly, Primary Autosomal Recessive, 6 Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Health Sciences University Konya Beyhekim Training and Research Hospital

Konya, Selçuklu, 42060, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Individuals who have used NIV at home for at least 4 months or more,
  • Adults over the age of 18
  • No communication barrier,
  • Whether the caregiver or the individual himself is using a smart phone,
  • Having internet access,
  • Ability to read and understand Turkish.

Exclusion criteria

  • Myocardial infarction or cerebrovascular accident, schizophrenia, etc. in the last 3 months. Individuals who cannot provide their own self-care due to illness,
  • Being diagnosed with cancer,
  • Being hospitalized with acute exacerbation,

Treatment and study plan

Web-based education

Behavioral

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.

Primary outcomes

  1. S³-NIV Questionnaire Total Score

    Time frame: Baseline, Week 4, and Week 8

    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.

  2. Insomnia Severity Index (ISI) Total Score

    Time frame: Baseline, Week 4, and Week 8

    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.

Secondary outcomes

  1. S³-NIV Respiratory Symptoms Subscale Score

    Time frame: Baseline, Week 4, and Week 8

    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.

  2. S³-NIV Sleep/NIV-Related Side Effects Subscale Score

    Time frame: Baseline, Week 4, and Week 8

    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.

Sponsors and collaborators

Lead sponsor

KTO Karatay University

Other

Registry information

Official study title

The Effect of Web-Based "NIV Living Training" on NIV Compliance and Insomnia Severity in Individuals Using Noninvasive Ventilators (NIV) at Home: Randomized Controlled Study

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 2, 2024
Registry last updated
Sep 2, 2026

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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