Viewing Study NCT04691479



Ignite Creation Date: 2024-05-06 @ 3:37 PM
Last Modification Date: 2024-10-26 @ 1:53 PM
Study NCT ID: NCT04691479
Status: COMPLETED
Last Update Posted: 2020-12-31
First Post: 2020-12-21

Brief Title: Adherence and Quality of Life of CPAP for Obstructive Sleep Apnea
Sponsor: Air Liquide Healthcare Spain
Organization: Air Liquide Healthcare Spain

Study Overview

Official Title: Adherence and Quality of Life of CPAP for Obstructive Sleep Apnea With an Intervention Based on Stratification and Personalization of Care Plans a Randomized Controlled Trial
Status: COMPLETED
Status Verified Date: 2020-12
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: PIMA1-JO-PR
Brief Summary: A multicentre randomized controlled trial RCT designThe control group followed the usual treatment while the intervention group PIMA followed the treatment with an adapted and flexible care plan depending on socio-demographic clinical and psychological variables The treatment plan includes different channels home telephone care center a continuous evaluation and the use of the motivational interview in each of the interventions with the patient The main outcome was adherence Secondary outcomes were quality of life emotional state activities social relationships perceived competence and motivation
Detailed Description: The aim of this trial was to determine adherence to CPAP and health- related outcomes in patients with OSA via a comprehensive and multidisciplinary program based on stratification and individualized care plans including the motivational interview

A multicentre randomized controlled trial RCT design was used The control group followed the usual treatment while the intervention group PIMA followed the treatment with an adapted and flexible care plan depending on socio-demographic clinical and psychological variables The treatment plan includes different channels home telephone care center a continuous evaluation and the use of the motivational interview in each of the interventions with the patient The main outcome was adherence Secondary outcomes were quality of life emotional state activities social relationships perceived competence and motivation

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
3450 REGISTRY Ethics Committee for Clinical Research None