- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT04249518
Video Extradition of Continuous Positive Airway Pressure - Influence on Compliance
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Förväntat)
Fas
- Inte tillämpbar
Kontakter och platser
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Inget ingripande: nurse instruction of CPAP
Normal extradition.
45 minutes face to face with a nurse.
|
|
|
Experimentell: 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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
compliance in percentage
Tidsram: one month.
|
Compliance at one month follow up.
Minimum 0 % maximum 100 % compliance.
|
one month.
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Depression
Tidsram: 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
Tidsram: 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
Tidsram: 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 .
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Jesper Bille, MD, University Aarhus
Studieavstämningsdatum
Studera stora datum
Studiestart (Förväntat)
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- 15022020
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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