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

Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01552083
• Other study ID #: Etude SAS
• Status: Recruiting
• Phase: N/A
• First received: January 27, 2012
• Last updated: March 12, 2012
• Start date: January 2012
• Est. completion date: December 2012

Study information

• Verified date: March 2012
• Source: Institut National de la Santé Et de la Recherche Médicale, France
• Contact: Nathalie Pelletier-Fleury
• Phone: +33149583325
• Email: npfleury[@]vjf.cnrs.fr
• Is FDA regulated: No
• Health authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Apnea
• Sleep Apnea
• Sleep Apnea Syndromes

Intervention

Other:
• screening of sleep apnea
2 validated screening questionnaires (Berlin questionnaire, Epworth scale)

Locations

Country	Name	City	State
France	Cermes3, CNRS UMR8211 - Inserm U988	Villejuif

Sponsors (2)

Lead Sponsor	Collaborator
Institut National de la Santé Et de la Recherche Médicale, France	France: Centre National de la Recherche Scientifique

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients referred by the general practitioner to sleep specialist for SAS diagnosis test		6 months after the intervention of pharmacists.	No
Secondary	Satisfaction of patients and pharmacists		6 months after the intervention of pharmacist	No
Secondary	Proportion of patients with sleep apnea		6 months after the intervention of pharmacists	No