跳至主要内容
临床试验/NCT01552083
NCT01552083Unknown不适用

A Community Pharmacist-led Intervention to Improve Screening of Sleep Apnea in Primary Care

Institut National de la Santé Et de la Recherche Médicale, France2 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2012年1月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
400
试验地点
2
主要终点
Proportion of patients referred by the general practitioner to sleep specialist for SAS diagnosis test

研究概览

简要总结

The purpose of this study is to evaluate the feasibility and the effectiveness of sleep apnea screening program for patients at risk in community pharmacies.

详细描述

Background: The sleep apnea syndrome (SAS) is a common disease but unknown. According to epidemiological studies, approximately 5% to 10% of the general population is living with SAS. Untreated sleep apnea has an important individual impact: it is accompanied by sleep disturbances and vigilance and frequent co-morbidities such as hypertension, diabetes or other cardiovascular diseases. Also, it has a cost to the community due to significant traffic accidents and work accidents more frequent in this population and weight for health insurance for cardiovascular diseases. However, its screening and its management remain largely insufficient. The report of the Ministry of Health in 2006 estimated that only 15% of subjects with a SAS would be diagnosed.

The Law "Hospital, Patients, Health and Territories" (HPST) in 2009 provides pharmacists with new responsibilities in the health screening, care coordination, or in therapeutic education (Article 38 of Law HPST).

Objective

In this dual context, this study aims to assess the feasibility and effectiveness of an information campaign and screening of SAS in patients at risk in the community pharmacies. The investigators analyze whether the involvement of community pharmacists in the care pathway of a patient at risk is effective, that is to say if it improves the detection rate and diagnostic the disease in this population.

Project Description: 400 patients at risk of SAS will be recruited by the participating pharmacists. Screening intervention consists in 2 validated questionnaires which evaluate SAS risk (Berlin Questionnaire, Epworth Sleepiness Scale). Pharmacist distributes also an information leaflet about SAS, and refers patient to general practitioner with questionnaires results. Patients are followed by the pharmacists for 6 months.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Screening
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Taking 1 or more anti-hypertension drugs
  • Overweight (BMI > 25)
  • Signed informed consent

排除标准

  • To have a sleep apnea treatment
  • Not to have a referent doctor
  • To have a long-term illness
  • Did not sign informed consent

结局指标

主要结局

Proportion of patients referred by the general practitioner to sleep specialist for SAS diagnosis test

时间窗: 6 months after the intervention of pharmacists.

次要结局

  • Satisfaction of patients and pharmacists(6 months after the intervention of pharmacist)
  • Proportion of patients with sleep apnea(6 months after the intervention of pharmacists)

研究者

发起方
Institut National de la Santé Et de la Recherche Médicale, France
申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验