Clinical trial NCT06343324: Effect of Web-Based Adaptation and Insomnia Severity in Individuals Using Noninvasive Ventilators at Home
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Noninvasive Ventilation
COPD
Keywords: copd
bıpap
cpap
noninvasive ventilation
home type non invasive ventilation
web-based education
Lead sponsor: KTO Karatay University
Sponsor class: OTHER
First posted: 2024-04-02
Enrollment: 80
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Individuals who have used NIV at home for at least 4 months or more,
* Individuals between the ages of 50-75,
* 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,

Primary outcomes:
measure: Patient Identifiable Characteristics Form
timeFrame: 1 minute
Secondary outcomes:
measure: S³-NIV Questionnaire
timeFrame: 3 minute
Other outcomes:
measure: insomnia severity index
timeFrame: 5 minute
measure: Expected behavioral changes in the individual survey
timeFrame: 1 minute
Locations:
city: Konya
country: Turkey
facility: Health Sciences University Konya Beyhekim Training and Research Hospital
state: Selçuklu
Study officials:
affiliation: study principal investigator
name: Şahabettin ERİŞ, MScN
role: PRINCIPAL_INVESTIGATOR
References: