Clinical trial NCT04691479: Adherence and Quality of Life of CPAP for Obstructive Sleep Apnea
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Apnea, Obstructive
Keywords: CPAP
Sleep Apnea
Adherence
Quality of Life
Lead sponsor: Air Liquide Healthcare Spain
Sponsor class: INDUSTRY
Collaborators: name: Hospital Universitari Joan XXIII de Tarragona.
name: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
First posted: 2020-12-31
Enrollment: 129
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A multicentre, randomized controlled trial (RCT) design.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.

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.

Eligibility criteria: Inclusion Criteria:

* Older than 18 years
* Diagnosis of OSA confirmed by sleep studies with polygraphy (PS) and / or polysomnography (PSG)

Exclusion Criteria:

* Subjects with obesity-related hypoventilation
* Severe COPD (chronic obstructive pulmonary disease)
* Cognitive disorders and those unable to understand the consent to participate

Primary outcomes:
measure: Adherence (changes)
timeFrame: Day 90, Day 180
measure: Somnolence (changes)
timeFrame: Day 1, Day 90, Day 180
measure: Perceived Competence (changes)
timeFrame: Day 1, Day 90, Day 180
Secondary outcomes:
measure: Quality of Life (Changes)
timeFrame: Day 1, Day 90, Day 180
measure: Mood (Changes)
timeFrame: Day 1, Day 90, Day 180
measure: Activities (Changes)
timeFrame: Day 1, Day 90, Day 180
measure: Social Relations (Changes)
timeFrame: Day 1, Day 90, Day 180
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: David Rudilla
Study officials:
affiliation: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
name: Pedro Landete, PhD
role: PRINCIPAL_INVESTIGATOR
References: