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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Institut National de la Santé Et de la Recherche Médicale, France.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
France: Centre National de la Recherche Scientifique
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier:
NCT01552083
First received: January 27, 2012
Last updated: March 12, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention
Sleep Apnea
Other: screening of sleep apnea

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Institut National de la Santé Et de la Recherche Médicale, France:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 400
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)
Intervention Details:
    Other: screening of sleep apnea
    2 validated screening questionnaires (Berlin questionnaire, Epworth scale)
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01552083

Contacts
Contact: Nathalie Pelletier-Fleury +33149583325 npfleury@vjf.cnrs.fr
Contact: Clémence Perraudin +33149583486 clemence.perraudin@gmail.com

Locations
France
Cermes3, CNRS UMR8211 - Inserm U988 Recruiting
Villejuif, France, 94800
Contact: Nathalie Pelletier-Fleury    +33149583325    npfleury@vjf.cnrs.fr   
Contact: Clémence Perraudin    +33149583486    clemence.perraudin@gmail.com   
Principal Investigator: Nahalie Pelletier-Fleury         
Sponsors and Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
France: Centre National de la Recherche Scientifique
Investigators
Principal Investigator: Nathalise Pelletier-Fleury Institut National de la Santé Et de la Recherche Médicale, France
  More Information

No publications provided

Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier: NCT01552083     History of Changes
Other Study ID Numbers: Etude SAS
Study First Received: January 27, 2012
Last Updated: March 12, 2012
Health Authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé

Keywords provided by Institut National de la Santé Et de la Recherche Médicale, France:
sleep apnea
screening
community pharmacy

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Dyssomnias
Nervous System Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms
Signs and Symptoms, Respiratory
Sleep Disorders
Sleep Disorders, Intrinsic

ClinicalTrials.gov processed this record on November 25, 2014