Clinical trial NCT05385302: Sociological Determinants of Positive Airway Pressure Adherence in OSA Patients
Official title: Sociological Determinants of Adherence to Continuous Positive Airway Pressure In the Management of Sleep Apnea Syndrome - A Transdisciplinary Approach.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Adherence, Treatment
Health Literacy
Obstructive Sleep Apnea
Keywords: Adherence
treatment refusal
CPAP
Obstructive sleep apnea
Health literacy
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: ODENORE
name: HP2 Laboratory
First posted: 2022-05-23
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Obstructive Sleep Apnea patients with cPAP indication

Brief summary: Multicentric, prospective, opened study to evaluate the impact of Health Literacy Levels on CPAP withdrawal in Obstructive Sleep Apnea patients within 6 months of inclusion.

Detailed description: Obstructive sleep apnea syndrome (OSA) is a chronic multi-organ pathology and heterogeneous in its presentation and phenotypes.

To date, continuous positive airway pressure (CPAP) is the first-line treatment for OSA. In France, 1.2 million patients are treated with CPAP but 15% of patients refused the device at the time of diagnosis and the rate of non-adherence reach 43% 3 years after CPAP initiation.

Both in terms of sleepiness and cardiovascular symptoms, clinical improvement is correlated with normalization of ventilation and therefore with the use of CPAP throughout the sleep period by the patients. Adherence to CPAP is nowadays achieved by the contribution of tele-observance, which provides prescribers, home health care providers and patients with daily feedback on the effectiveness and compliance of the therapy.

To date, studies targeting the predictive factors of CPAP compliance in OSA patients mainly include clinical data (age, sex, severity of OSAS, symptoms, etc.), or technical factors directly related to CPAP treatment (type of mask, residual apnea hypopnea index (AHI) under treatment, leakage, side effects, etc.).

The social, socioeconomic and psychological approaches are far less studied and frankly underestimated, although they are gradually gaining interest, representing the submerged part of the iceberg. Some studies have shown an association between poor socioeconomic status and poor compliance with CPAP, while others have focused on psychological factors. Finally, in the work of our team, we have recently looked at the impact of the marital on compliance and the perception of the associated benefit. However, each study targets a specific area, without taking into account the clinical and individual determinants. Therefore, there is a lack of knowledge about individual determinants of CPAP adherence.

Health literacy, defined as "the ability to access, understand, evaluate, and communicate information in ways that promote, maintain, and improve one's health in a variety of settings across the lifespan" is a possible important limitation for a patient to understand the need for PAP treatment and was never explored in view to explain CPAP adherence.

This project aims to exploit a unique transdisciplinary approach to characterize refusal, discontinuation, and nonadherence to CPAP in patients with diagnosed OSA newly managed on CPAP.

The main hypothesis of the study is that a patient with an insufficient level of health literacy (LS) (score from 0 to 8 defined from the European Health Literacy Survey questionnaire) has a greater probability of stopping treatment early or of being non-compliant than a patient with better performance in terms of health literacy.

Eligibility criteria: Inclusion Criteria:

* Patient newly diagnosed with OSA
* Patient with indication for CPAP
* Voluntary patient with informed consent and no objection to participation
* Patient affiliated with or benefiting from a social security plan

Non-Inclusion Criteria:

* Person deprived of liberty by judicial or administrative decision, person subject to a legal protection measure (patient under guardianship or curators) according to articles L1121-5 to L1121-8
* Refusal of participation by the patient
* Patient refusing telemonitoring

Primary outcomes:
measure: To study the impact of health literacy levels on CPAP discontinuation in newly fitted OSA patients
timeFrame: Between initiation of CPAP (day 7 to 15 after inclusion) to V2 (6 months after inclusion)
Secondary outcomes:
measure: To study the impact of health literacy levels on CPAP refusal after diagnosis.
timeFrame: At V1 (inclusion)
measure: To investigate the impact of health literacy levels on adherence status. With adherence status defined here in several ways (≥4h vs <4h; adherence quartiles or adherence clusters).
timeFrame: At 6 month (V2)
measure: To study the interactions between the different socio-economic factors studied and their influence on adherence to the CPAP treatment
timeFrame: At 6 month
measure: Define the relationship between various clinical, social, economic, environmental determinants and adherence in addition to health literacy.
timeFrame: At 6 months
measure: Identify profiles of patients who refuse CPAP or are non- adherent or who have stopped CPAP according to personal determinants
timeFrame: At 6 months
measure: Determine adherence trajectories as a function of health literacy and specifically study the specific determinants of adherence.
timeFrame: Over 6 months
measure: To decipher the links made by people in treatment discontinuation or qualified as non-observant from the medical point of view, between the different factors of non-observance identified.
timeFrame: within 15 days of refusal of CPAP treatment, or within 15 days of discontinuation of treatment during the 6-month follow-up, or within 15 days of visit 2 for both non-adherent and adherent patients at 6 months.
measure: Understand how people explain these situations based on their life contexts, representations of the disease and treatment, particularly their understanding of the issues involved.
timeFrame: Within 15 days of refusal of treatment for patients refusing CPAP, or within 15 days of discontinuation of treatment for patients who stopped treatment during the 6-month follow-up, or within 15 days of visit 2 for non-adherent patients at 6 month
measure: Analyze people's perceptions of their health information practices, their relationship with the medical profession and the role of those involved in their pathology to understanding CPAP treatment
timeFrame: Within 15 days of refusal of treatment for patients refusing CPAP, or within 15 days of discontinuation of treatment during the 6-month follow-up, or within 15 days of visit 2 for all patients at 6 month
measure: Identify the change in adherent patient's relationship to their treatment and the perceived benefits
timeFrame: Within 6 months of the first interview
measure: Describe the evolution of non-adherent patient's situation, the health and potential compensation strategies or alternatives that they have implemented to limit the impact of their untreated OSAS
timeFrame: Within 6 months of the first interview for non-adherent patients
Other outcomes:
Locations:
city: La Tronche
country: France
facility: CHUGA
city: Saint-Martin-d'Hères
country: France
facility: Centre du Sommeil de Grenoble
Study officials:
affiliation: Sleep and respiratory diseases Lab, CHU Grenoble Alpes
name: Sébastien Bailly, PharmD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Benjafield AV, Ayas NT, Eastwood PR, Heinzer R, Ip MSM, Morrell MJ, Nunez CM, Patel SR, Penzel T, Pepin JL, Peppard PE, Sinha S, Tufik S, Valentine K, Malhotra A. Estimation of the global prevalence and burden of obstructive sleep apnoea: a literature-based analysis. Lancet Respir Med. 2019 Aug;7(8):687-698. doi: 10.1016/S2213-2600(19)30198-5. Epub 2019 Jul 9.