A Community Pharmacist-led Intervention to Improve Screening of Sleep Apnea in Primary Care
Recruitment status was: Recruiting
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
|Official Title:||A Community Pharmacist-led Intervention to Improve Screening of Sleep Apnea in Primary Care|
- Proportion of patients referred by the general practitioner to sleep specialist for SAS diagnosis test [ Time Frame: 6 months after the intervention of pharmacists. ] [ Designated as safety issue: No ]
- Satisfaction of patients and pharmacists [ Time Frame: 6 months after the intervention of pharmacist ] [ Designated as safety issue: No ]
- Proportion of patients with sleep apnea [ Time Frame: 6 months after the intervention of pharmacists ] [ Designated as safety issue: No ]
|Study Start Date:||January 2012|
|Estimated Study Completion Date:||December 2012|
|Estimated Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
Other: screening of sleep apnea
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01552083
|Cermes3, CNRS UMR8211 - Inserm U988|
|Villejuif, France, 94800|
|Principal Investigator:||Nathalise Pelletier-Fleury||Institut National de la Santé Et de la Recherche Médicale, France|