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

NCT ID: NCT07258264

Last Updated: 2025-12-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-30
• Study Completion Date: 2019-10-21

Brief 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

Apnea (Central and Obstructive)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Motivational Interviewing - MEntA

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.

Group Type: EXPERIMENTAL

Motivational Interviewing (MI)

Intervention Type: BEHAVIORAL

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

Competency-based learning - Control

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.

Group Type: ACTIVE_COMPARATOR

Competency-based learning

Intervention Type: BEHAVIORAL

Consists 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

Interventions

Motivational 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

Intervention Type: BEHAVIORAL

Competency-based learning

Consists 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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• To have a diagnosis of OSA confirmed by polysomnography (PSG)
• CPAP treatment prescription
• First time with this type of intervention.

Exclusion Criteria

• Subjects requiring bi-level ventilation
• Pacients with central sleep apnoea syndrome
• Patients with severe chronic obstructive pulmonary disease (COPD)
• Patients with cognitive disorders and those unable to understand the consent form to participate.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Air Liquide Healthcare Spain

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospital Universitario de La Princesa

Madrid, Madrid, Spain

Countries

Spain

References

Rudilla D, Landete P, Zamora E, Roman A, Vergara I, Ancochea J. MEntA Program Based on Motivational Interview to Improve Adherence to Treatment of Obstructive Sleep Apnea With Continuous Positive Airway Pressure (CPAP): A Randomized Controlled Trial. Open Respir Arch. 2021 Mar 16;3(2):100088. doi: 10.1016/j.opresp.2021.100088. eCollection 2021 Apr-Jun.

Reference Type: RESULT

PMID: 37497068 (View on PubMed)

Other Identifiers

3687

Identifier Type: -

Identifier Source: org_study_id