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Clinical Trials/NCT01552083
NCT01552083UnknownNot Applicable

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 sites in 1 country400 target enrollmentStarted: January 1, 2012Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
400
Locations
2
Primary Endpoint
Proportion of patients referred by the general practitioner to sleep specialist for SAS diagnosis test

Study Overview

Brief Summary

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.

Detailed Description

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Screening
Masking
None

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: 6 months after the intervention of pharmacists.

Secondary Outcomes

  • 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)

Investigators

Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
Sponsor Class
Other Gov
Responsible Party
Sponsor

Study Sites (2)

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