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

NCT ID: NCT01552083

Last Updated: 2012-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2012-12-31

Brief Summary

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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

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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.

Conditions

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Sleep Apnea

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Interventions

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screening of sleep apnea

2 validated screening questionnaires (Berlin questionnaire, Epworth scale)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Taking 1 or more anti-hypertension drugs
* Overweight (BMI \> 25)
* Snoring
* 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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Centre National de la Recherche Scientifique, France

OTHER

Sponsor Role collaborator

Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nathalise Pelletier-Fleury

Role: PRINCIPAL_INVESTIGATOR

Institut National de la Santé Et de la Recherche Médicale, France

Locations

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Cermes3, CNRS UMR8211 - Inserm U988

Villejuif, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Nathalie Pelletier-Fleury

Role: CONTACT

+33149583325

Clémence Perraudin

Role: CONTACT

+33149583486

Facility Contacts

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Nathalie Pelletier-Fleury

Role: primary

+33149583325

Clémence Perraudin

Role: backup

+33149583486

Other Identifiers

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Etude SAS

Identifier Type: -

Identifier Source: org_study_id

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