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

Primary Purpose

Sleep Apnea

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
screening of sleep apnea
Sponsored by
Institut National de la Santé Et de la Recherche Médicale, France
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional screening trial for Sleep Apnea focused on measuring sleep apnea, screening, community pharmacy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Cermes3, CNRS UMR8211 - Inserm U988Recruiting

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Satisfaction of patients and pharmacists
Proportion of patients with sleep apnea

Full Information

First Posted
January 27, 2012
Last Updated
March 12, 2012
Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
Collaborators
Centre National de la Recherche Scientifique, France
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1. Study Identification

Unique Protocol Identification Number
NCT01552083
Brief Title
A Community Pharmacist-led Intervention to Improve Screening of Sleep Apnea in Primary Care
Official Title
A Community Pharmacist-led Intervention to Improve Screening of Sleep Apnea in Primary Care
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Unknown status
Study Start Date
January 2012 (undefined)
Primary Completion Date
June 2012 (Anticipated)
Study Completion Date
December 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
Collaborators
Centre National de la Recherche Scientifique, France

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea
Keywords
sleep apnea, screening, community pharmacy

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
screening of sleep apnea
Intervention Description
2 validated screening questionnaires (Berlin questionnaire, Epworth scale)
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Satisfaction of patients and pharmacists
Time Frame
6 months after the intervention of pharmacist
Title
Proportion of patients with sleep apnea
Time Frame
6 months after the intervention of pharmacists

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nathalie Pelletier-Fleury
Phone
+33149583325
Email
npfleury@vjf.cnrs.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Clémence Perraudin
Phone
+33149583486
Email
clemence.perraudin@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nathalise Pelletier-Fleury
Organizational Affiliation
Institut National de la Santé Et de la Recherche Médicale, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cermes3, CNRS UMR8211 - Inserm U988
City
Villejuif
ZIP/Postal Code
94800
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nathalie Pelletier-Fleury
Phone
+33149583325
Email
npfleury@vjf.cnrs.fr
First Name & Middle Initial & Last Name & Degree
Clémence Perraudin
Phone
+33149583486
Email
clemence.perraudin@gmail.com
First Name & Middle Initial & Last Name & Degree
Nahalie Pelletier-Fleury

12. IPD Sharing Statement

Learn more about this trial

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

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