Sociological Determinants of Adherence to Continuous Positive Airway Pressure In the Management of Sleep Apnea Syndrome - A Transdisciplinary Approach.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- To study the impact of health literacy levels on CPAP discontinuation in newly fitted OSA patients
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
结局指标
主要结局
To study the impact of health literacy levels on CPAP discontinuation in newly fitted OSA patients
时间窗: Between initiation of CPAP (day 7 to 15 after inclusion) to V2 (6 months after inclusion)
Proportion of CPAP treatment discontinuation without switch to mandibular advancement orthosis treatment
次要结局
- To study the impact of health literacy levels on CPAP refusal after diagnosis.(At V1 (inclusion))
- Define the relationship between various clinical, social, economic, environmental determinants and adherence in addition to health literacy.(At 6 months)
- Identify profiles of patients who refuse CPAP or are non- adherent or who have stopped CPAP according to personal determinants(At 6 months)
- Understand how people explain these situations based on their life contexts, representations of the disease and treatment, particularly their understanding of the issues involved.(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)
- 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(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)
- 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.(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.)
- 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).(At 6 month (V2))
- To study the interactions between the different socio-economic factors studied and their influence on adherence to the CPAP treatment(At 6 month)
- 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(Within 6 months of the first interview for non-adherent patients)
- Determine adherence trajectories as a function of health literacy and specifically study the specific determinants of adherence.(Over 6 months)
- Identify the change in adherent patient's relationship to their treatment and the perceived benefits(Within 6 months of the first interview)