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CompletedNCT07258264

MEntA Program Based on Motivational Interview to Improve Adherence to Treatment of Obstructive Sleep Apnea With Continuous Positive Airway Pressure (CPAP)

Programa Educativo y Formativo Basado en la Entrevista Motivacional Para Pacientes Con SAHS en Tratamiento Con CPAP: MEntA

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
100 (actual)
Sponsor
Air Liquide Healthcare Spain · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

A randomized, controlled, single-centre trial design was performed. The interventions were standard of care vs MEntA Program based on motivational interview for adherence. The main outcome was the adherence with the CPAP therapy after 90 days of treatment. Secondary outcomes were the motivation, perceived competence, quality of life, sleepiness, emotional state, activities and social relations.

Detailed description

The subjects enrolled in the study were required to have a diagnosis of OSA confirmed by polysomnography (PSG), be recommended for treatment with CPAP and be naïve to this type of intervention. The study excluded subjects requiring bi-level ventilation, such as those with central sleep apnoea syndrome, a CPAP assessment study, those with severe chronic obstructive pulmonary disease (COPD), cognitive disorders and those unable to understand the consent form to participate. Prior to enrolment in the study, all patients were informed in detail about the study and signed the consent form to participate. Standard of Care Group: subjects undergoing this training intervention follow the standard procedure. It consists of a CPAP School for the initiation of therapy, and follow-up visits (in person and/or by telephone) that follow the frequencies indicated by the Spanish Society of Pulmonology and Thoracic Surgery (SEPAR). The CPAP School consists of a single session lasting around 80 minutes. The theoretical training includes the importance of adherence, as well as handling the equipment and accessories, cleaning and maintenance of the equipment, and prevention of complications and possible side effects. The practical training consists of showing patients how to carry out the technique themselves. MEntA Group: subjects in this group underwent an intervention based on the motivational interviewing (MI) technique in CPAP School format for the initiation of therapy, and follow-up as indicated by SEPAR. MEntA CPAP School intervention consists of one session lasting approximately 90 minutes, which is divided into two blocks: educational activity and training activity. In the first block, an expert explains the concepts of sleep apnoea and the symptoms, while a patient shows the CPAP treatment and how to optimize this to the fullest. This block was reinforced with documentation in hard copy and digital format. The second block on training activity was based on working with the treatment, equipment, safety, hygiene and advice. MEntA has the specific contents but the key is in how these contents are treated with the patients, using the MI to the treatment of OSA with CPAP. For perceived competence was used the validated Questionnaire of Evaluation of Perceived Competence in Adherence to CPAP in OSA (CEPCA)9. This questionnaire consists of 3 categories and 13 items: knowledge of OSA and its associated risk; expectations regarding CPAP treatment; and confidence in overcoming obstacles associated with the use of this type of treatment. The scores obtained in the CEPCA imply they are positively related to quality of life and motivation and negatively related to daytime sleepiness. The quality of life was assessed using the Visual Analogical Well-being Scale for apnoea10 and sleepiness was assessed using the Epworth Sleepiness Scale (ESS)11,12. Finally, emotional state, daily activities and social relationships were also measured using the following ad hoc question "Taking into account your sleep problems, how would say you are in terms of mood / activities / social relationships?". The answer alternatives are: Good, Normal / no change, Bad.

Conditions

Interventions

TypeNameDescription
BEHAVIORALMotivational Interviewing (MI)Collaborative and person-centered counseling style designed to help people explore and resolve their ambivalence about change, thereby strengthening their intrinsic motivation to make positive behavioral changes
BEHAVIORALCompetency-based learningConsists of exposing the contents in a "classroom" format and promoting the acquisition of the contents of each aspect through practice. The training focuses on the skills of handling and use of CPAP

Timeline

Start date
2019-05-30
Primary completion
2019-10-21
Completion
2019-10-21
First posted
2025-12-02
Last updated
2025-12-02

Locations

1 site across 1 country: Spain

Source: ClinicalTrials.gov record NCT07258264. Inclusion in this directory is not an endorsement.