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Video Extradition of Continuous Positive Airway Pressure - Influence on Compliance

24. marts 2020 opdateret af: University of Aarhus
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.

Studieoversigt

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

1234

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 99 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • candidate to CPAP
  • over age of 18

Exclusion Criteria:

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: nurse instruction of CPAP
Normal extradition. 45 minutes face to face with a nurse.
Eksperimentel: Video extradition
Access to 7 min video - explaining how to start CPAP and how to adjust the mask.
No drugs used. The only difference in the to arms is the way the extradition is.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
compliance in percentage
Tidsramme: one month.
Compliance at one month follow up. Minimum 0 % maximum 100 % compliance.
one month.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Depression
Tidsramme: one month.
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
Tidsramme: one month.
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
Tidsramme: One month .
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 .

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Jesper Bille, MD, University Aarhus

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Forventet)

15. maj 2020

Primær færdiggørelse (Forventet)

15. februar 2022

Studieafslutning (Forventet)

15. februar 2023

Datoer for studieregistrering

Først indsendt

17. januar 2020

Først indsendt, der opfyldte QC-kriterier

28. januar 2020

Først opslået (Faktiske)

31. januar 2020

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

25. marts 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. marts 2020

Sidst verificeret

1. oktober 2019

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 15022020

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

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Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Patientengagement

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