Clinical trial NCT05767190: The MotivAir Study to Improve CPAP Adherence in OSAS Patients
Official title: The MotivAir Study: a Randomized Controlled Trial of Motivational Interviewing-Based Intervention to Improve Adherence to CPAP in Patients With Obstructive Sleep Apnea Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sleep Apnea, Obstructive
Motivational Interviewing
Lead sponsor: Istituto Auxologico Italiano
Sponsor class: OTHER
First posted: 2023-03-14
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the effectiveness of the MotivAir program an intervention based on Motivational Interviewing (MI) principles and techniques - in enhancing adherence to Continuous Positive Airway Pressure (CPAP) therapy among patients with Obstructive Sleep Apnea Syndrome (OSAS).

Methods. A multicenter randomized controlled trial (RCT) design with random allocation at the level of the individual will be conducted to compare the impact of the experimental program (usual care plus MI) with a control group receiving usual care only in improving selected clinical and psychological parameters in the patients.

A minimum sample of 80 participants (40 patients per group) will be recruited in each center according to the inclusion criteria. After the initial screening, participants will be randomly assigned to either the experimental group or the control condition. The program will last 180 days and will be delivered by a trained nurse. The impact of the MotivAir program on selected primary (adherence to CPAP in terms of average hours of usage per night and the Apnea-Hypopnea Index, AHI) and secondary (motivation, perceived competence, quality of life, sleepiness, as well as the emotional state, daily life activities, and quality of the social relationships of the person) outcomes will be measured at baseline, and after 1-, 3-, and 6-month from CPAP initiation

Detailed description: Socio-demographic (age, level of studies, presence of caregiver at home), psychological (motivation and perceived competence) clinical variables (somnolence and apnoea-hypopnea index), and variables concerning the time the patient spends from home to the care center and the confidence in using electronic applications will be used to classify patients' adherence to treatment as low, moderate or high, and to create a tailored motivational treatment plan for the subjects assigned to the experimental group. Patients showing low adherence will receive a more intensive care plan, than those recognized as highly compliant with CPAP use. The results are patients with the "a" profile (characterized by autonomy and mobility, predisposition to remote-controlled follow-up), patients with the "b" profile (need for more intensity in follow-up), or patients with the "c" profile (more difficulties to move around and require more intensive treatment). Profile "d" was applied to patients who were professional drivers, as they require specific interventions based on their occupation (see Rudilla et al., 2021a).

Participants assigned to the control group will receive a usual pulmonary rehabilitation program for patients with OSAS receiving CPAP therapy, which is a standard technical training comprising information regarding the use, maintenance and safety measures of the device, plus a home inspection delivered by a technician who has the only task of doing maintenance to the machinery.

In addition, subjects in the MotivAir group will follow a telephone-based intervention - lasting approximately 45 minutes - based on MI principles and techniques delivered by a nurse. For the specific purpose of the study, the nurse will preliminarily receive 8 hours of MI training provided by two psychologists experts in the MI approach (authors GR and GP). During the training, the nurse will learn about the collaborative, evocative, and client-centered spirit of MI, and the characteristics that define each stage of change and will be instructed to apply the basic communication and listening skills of this approach (open-ended questions, affirmations, reflective listening, summarizing). Then she will learn to reinforce and elicit change talk, while also responding in ways that reduce counter-change talk and to roll with the patients' inner resistance to change by affirming the patients' autonomy and reflecting their resistant speech with empathy. Next, the issues of how and when to introduce the development of a change plan, and enhance the individuals' commitment to change will be addressed.

The treatment plan will be implemented based on each patient's level of adherence. To low adherence (score below 16 on the ESS and CEPCA questionnaires) a more intensive telephone-based assistance (day 1, 8, 16, 30, 90, 120, 180 from the end of the rehabilitation period) will follow. In the case of high adherence (score greater than or equal to 16 on the ESS and CEPCA questionnaires), phone encounters will be set on days 1, 8, 30, 90, and 180 after treatment termination.

At 1-, 3- and 6-month follow-up, adherence to the device will be assessed by automatedly recorded CPAP usage (hours/night) and AHI. Changes in the selected psychological variable will be also examined.

Eligibility criteria: Inclusion Criteria:

* having a diagnosis of OSAS confirmed by polysomnography;
* being recommended for treatment with CPAP;
* being naïve to this type of intervention

Exclusion Criteria:

* use of oxygen therapy \> 2 l/min;
* history of severe cognitive disorders;
* history of COPD: FEV1/FVC (Tiffeneau Index) ≤ 60% with FEV1 ≤ 50%;
* dyspnea on exertion (Borg \> 6);
* diagnosis of Long Covid or Covid-19 infection \< 4 months;
* chronic heart failure (NYHA: Grade III and IV);
* unstable ischemic heart disease;
* inability to understand the consent to participate;
* patient refusal.

Primary outcomes:
measure: Change from Baseline adherence to CPAP at 6 months
timeFrame: 6 months from CPAP initiation
measure: Change from baseline Apnea-Hypopnea Index (AHI) at 6 months
timeFrame: 6 months from CPAP initiation
Secondary outcomes:
measure: Change from baseline Motivation to change at 6 months
timeFrame: 6 months from CPAP initiation
measure: Change from baseline of Evaluation of Perceived Competence in Adherence to CPAP in OSAS at 3 and 6 months
timeFrame: 6 months from CPAP initiation
measure: Change from Baseline of Visual Analogical Well-being Scale for apnea at 6 months
timeFrame: 6 months from CPAP initiation
Other outcomes:
Locations:
city: Verbania
country: Italy
facility: San Giuseppe Hospital, Istituto Auxologico Italiano IRCSS
Study officials:
affiliation: Istututo Auxologico Italiano
name: Gianluca Castelnuovo, PhD
role: PRINCIPAL_INVESTIGATOR
References: