A Community Pharmacist-led Intervention to Improve Screening of Sleep Apnea in Primary Care
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01552083|
Recruitment Status : Unknown
Verified March 2012 by Institut National de la Santé Et de la Recherche Médicale, France.
Recruitment status was: Recruiting
First Posted : March 13, 2012
Last Update Posted : March 13, 2012
|Condition or disease||Intervention/treatment||Phase|
|Sleep Apnea||Other: screening of sleep apnea||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||400 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Community Pharmacist-led Intervention to Improve Screening of Sleep Apnea in Primary Care|
|Study Start Date :||January 2012|
|Estimated Primary Completion Date :||June 2012|
|Estimated Study Completion Date :||December 2012|
- Other: screening of sleep apnea
2 validated screening questionnaires (Berlin questionnaire, Epworth scale)
- Proportion of patients referred by the general practitioner to sleep specialist for SAS diagnosis test [ Time Frame: 6 months after the intervention of pharmacists. ]
- Satisfaction of patients and pharmacists [ Time Frame: 6 months after the intervention of pharmacist ]
- Proportion of patients with sleep apnea [ Time Frame: 6 months after the intervention of pharmacists ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01552083
|Contact: Nathalie Pelletier-Fleuryemail@example.com|
|Contact: Clémence Perraudinfirstname.lastname@example.org|
|Cermes3, CNRS UMR8211 - Inserm U988||Recruiting|
|Villejuif, France, 94800|
|Contact: Nathalie Pelletier-Fleury +33149583325 email@example.com|
|Contact: Clémence Perraudin +33149583486 firstname.lastname@example.org|
|Principal Investigator: Nahalie Pelletier-Fleury|
|Principal Investigator:||Nathalise Pelletier-Fleury||Institut National de la Santé Et de la Recherche Médicale, France|