Video Extradition of Continuous Positive Airway Pressure - Influence on Compliance

Confirming or denying it in the future is an opportunity for certain patient groups to have the option of video delivery. So that in calm circumstances and possibly. several times can review the video and equipment in the home and hopefully achieve the same or better compliance with the ongoing treatment.

Study Overview

• Status: Unknown
• Conditions: Patient Engagement; Patient Empowerment; Patient Compliance
• Intervention / Treatment: Behavioral: Videoeducation

Detailed Description

Due to increasing age, BMI and increased focus on obstructive sleep apnea syndrome (OSAS) in the background population, an increasing number of obstructive sleep apnea (OSA) patients are expected to occur in the coming years. This is accompanied by a need for multiple deliveries of CPAP equipment, which is the recommended treatment. A large proportion of patients are young and healthy with their OSA. There is an increased focus on telemedicine and much of the control of patients has been transferred to ambuflex, where treatment effect or treatment problems can be more easily detected. Socioeconomically, the deliveries, together with the medical examination, are resource-intensive and they also take up a lot of the patient's time and often at distant times. The quality of disclosure and information varies greatly in both time and amount of information. The large amount of information can be difficult to remember for patients and relatives. Most investigations require more visits to the hospital and therefore potentially provide several days away from work.

A similar trial has never been made, but randomized studies have been made in the past where the delivery of CPAP or low compliance patients has been supported by a motivational video or teaching with good effect. Studies have also been conducted that have attempted to identify CPAP dropout and compliance based on gender, age, educational level and personality, with unemployment being the only contributing prognostic factor in the negative direction. It is well-studied that if patients suffer from insomnia, the onset of CPAP can be difficult and this patient group should be monitored more closely and possibly. have additional help for startup.

The video in this study provides a brief review of illness and treatment, instruction on assembling and adapting equipment, and answers to the most frequently asked questions. Both groups are given the same telephone numbers as usual, for questions and here it will be included in the study if there is a difference in the amount of contacts to the ambulatory. The video has been tested in the relevant setting before starting the project. M Gaglianos made in 1988 is a literature review showing that video teaching is good and more effective than traditional teaching methods, with effects on short-term but not long-term memory.

• Study Type: Interventional
• Enrollment (Anticipated): 1234
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jesper Bille, MD; Phone Number: 0045+61651750; Email: doctor.bille@gmail.com
• Study Contact Backup: Name: Milos Fuglsang, MD; Phone Number: 0045+24463040; Email: milosfuglsang@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• candidate to CPAP
• over age of 18

Exclusion Criteria:

• Language issues
• sight or hearing handicap
• kognitive issues
• if drivers license is confiscated

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: nurse instruction of CPAP; Normal extradition. 45 minutes face to face with a nurse.
Experimental: Video extradition; Access to 7 min video - explaining how to start CPAP and how to adjust the mask.	Behavioral: Videoeducation; No drugs used. The only difference in the to arms is the way the extradition is.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
compliance in percentage	Compliance at one month follow up. Minimum 0 % maximum 100 % compliance.	one month.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression	Depression measured by major depression index (MDI) questionnaire.MDI total score < 20 being normal and not depressed. MDI total score > 29 indicating severe depression.	one month.
Influencer	Education level registered by ISCED 2011 levels of education. Level 0-8. 8 being doctoral or equivalent. 0 being Early childhood Education (01 Early childhood educational development)	one month.
Insomnia	Insomnia measured by insomnia severity index (questionnaire). 0-12 points. 0 being no problems facing a sleep. 12 having lots og trouble falling a sleep.	One month .

Collaborators and Investigators

• Sponsor: University of Aarhus
• Investigators: Principal Investigator: Jesper Bille, MD, University Aarhus

Study record dates

Study Major Dates

• Study Start (Anticipated): May 15, 2020
• Primary Completion (Anticipated): February 15, 2022
• Study Completion (Anticipated): February 15, 2023

Study Registration Dates

• First Submitted: January 17, 2020
• First Submitted That Met QC Criteria: January 28, 2020
• First Posted (Actual): January 31, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2020
• Last Update Submitted That Met QC Criteria: March 24, 2020
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 15022020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No