Video Extradition of Continuous Positive Airway Pressure - Influence on Compliance

NCT ID: NCT04249518

Last Updated: 2020-03-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

1234 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-15

Study Completion Date

2023-02-15

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Patient Empowerment Patient Engagement Patient Compliance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

RCT
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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nurse instruction of CPAP

Normal extradition. 45 minutes face to face with a nurse.

Group Type NO_INTERVENTION

No interventions assigned to this group

Video extradition

Access to 7 min video - explaining how to start CPAP and how to adjust the mask.

Group Type EXPERIMENTAL

Videoeducation

Intervention Type BEHAVIORAL

No drugs used. The only difference in the to arms is the way the extradition is.

Interventions

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Videoeducation

No drugs used. The only difference in the to arms is the way the extradition is.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* candidate to CPAP
* over age of 18

Exclusion Criteria

* Language issues
* sight or hearing handicap
* kognitive issues
* if drivers license is confiscated
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jesper Bille, MD

Role: PRINCIPAL_INVESTIGATOR

University Aarhus

Central Contacts

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Jesper Bille, MD

Role: CONTACT

0045+61651750

Milos Fuglsang, MD

Role: CONTACT

0045+24463040

Other Identifiers

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15022020

Identifier Type: -

Identifier Source: org_study_id

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