A Community Pharmacist-led Intervention to Improve Screen... | NCT01552083

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

NCT01552083

Sponsor

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

Status

Unknown status

Last Update Posted

Mar 13, 2012Estimated

Enrollment

400Estimated

Phase

Not Applicable

Conditions

Sleep Apnea

Interventions

screening of sleep apnea

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2012

Primary Completion Date

Jun 2012Estimated

Completion Date

Dec 2012Estimated

First Submitted Date

Jan 27, 2012

First Submission Date that Met QC Criteria

Mar 12, 2012

First Posted Date

Mar 13, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 12, 2012

Last Update Posted Date

Mar 13, 2012Estimated

Name	Class
Centre National de la Recherche Scientifique, France	OTHER

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

400Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
screening of sleep apnea	Other	2 validated screening questionnaires (Berlin questionnaire, Epworth scale)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Proportion of patients referred by the general practitioner to sleep specialist for SAS diagnosis test		6 months after the intervention of pharmacists.

Secondary Outcomes

Measure	Description	Time Frame
Satisfaction of patients and pharmacists		6 months after the intervention of pharmacist
Proportion of patients with sleep apnea		6 months after the intervention of pharmacists

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Nathalie Pelletier-Fleury	Contact	+33149583325		npfleury@vjf.cnrs.fr
Clémence Perraudin	Contact	+33149583486		clemence.perraudin@gmail.com

Overall Officials

Name	Affiliation	Role
Nathalise Pelletier-Fleury	Institut National de la Santé Et de la Recherche Médicale, France	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cermes3, CNRS UMR8211 - Inserm U988	Recruiting	Villejuif		94800	France

Condition Browse Module

MeSH Terms

ID	Term
D012891	Sleep Apnea Syndromes

Ancestor Terms

ID	Term
D001049	Apnea
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D020919	Sleep Disorders, Intrinsic

Browse Leaves

Not provided

Browse Branches

Not provided