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

NCT06343324 | Completed

• 1 other identifier: 2023/012
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Noninvasive Ventilation; COPD

Keywords

copd; bıpap; cpap; noninvasive ventilation; home type non invasive ventilation; web-based education

Outcome Measures

Primary Outcomes (1)

• Patient Identifiable Characteristics Form

  This form, prepared by the researcher using the literature, consists of 8 questions regarding the patients' sociodemographic (age, gender, education, etc.) and clinical characteristics (disease type, etc.).

  1 minute

Secondary Outcomes (1)

• S³-NIV Questionnaire

  3 minute

Other Outcomes (2)

• insomnia severity index

  5 minute

• Expected behavioral changes in the individual survey

  1 minute

Study Arms (2)

Experimental

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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.

Interventions

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.

Experimental

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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,

Sponsors & Collaborators

• KTO Karatay University: lead

Study Sites (1)

Health Sciences University Konya Beyhekim Training and Research Hospital

Konya, Selçuklu, 42060, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Microcephaly, Primary Autosomal Recessive, 6

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Şahabettin ERİŞ, MScN

  study principal investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nurse

Study Record Dates

• First Submitted: March 24, 2024
• First Posted: April 2, 2024
• Study Start: January 1, 2024
• Primary Completion: February 1, 2024
• Study Completion: July 1, 2024
• Last Updated: August 12, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)