Effect of Early Education on the Observance of CPAP Treatment (CoachSAS)
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|ClinicalTrials.gov Identifier: NCT02657304|
Recruitment Status : Recruiting
First Posted : January 15, 2016
Last Update Posted : June 25, 2020
|Condition or disease||Intervention/treatment||Phase|
|Sleep Apnea Syndrome||Behavioral: Coaching group Other: Control group||Not Applicable|
Sleep apnea (SA) affects more than 4% from general population (20% of people over 65 years) and is largely underdiagnosed, it can be rise up by some factors such as: obesity, male gender. Sleep Apnea can increase the occurrence of cardiovascular, endocrine and metabolic events (particularly stroke, diabetes & obesity). CPAP is currently the Gold Standard treatment of SA and to prevent these events, with a major clinical benefit, long term adherence to CPAP is a significant problem where a significant rate of rejection and abundance after 6 months of treatment.
The investigators hypothesize that an early education and information of SA (in the first 2 weeks after diagnosis of SA and one telephonic call/month while 5 months) would allow to increase significantly the optimal observance of CPAP (> 5 h/night).
Thus, in this study, we will compare evolution of the observance of CPAP (h/night), of the apnea hypopnea index (AHI), patient knowledge of their SA and its deleterious health consequences in an early education and information during five months against a control group receiving only usual care (standard).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effect of Early Education and Information of Sleep Apnea on the Observance of CPAP Treatment|
|Actual Study Start Date :||March 21, 2016|
|Estimated Primary Completion Date :||September 2021|
|Estimated Study Completion Date :||February 2022|
Experimental: Coaching group
PPC + Coaching
Behavioral: Coaching group
patients will have a medical consultation at 2 weeks post-diagnostic and one phone call/month for duration of 5 months. The consultations will use visual support, CPAP device and its accessories.
Active Comparator: Control group
Other: Control group
patients receive only usual care (standard), it's mean: diagnosis with explanation of the disease and benefit of CPAP, entrusts a medical device provider, then an appointment proposed by the doctor or taken by the patient (5 months).
- Observance [ Time Frame: 5 months ]Percentage of patients with a mean duration of observance of more than 5h/night after five months of follow-up in the coached and the control groups
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02657304
|Contact: Frédéric ROCHE, MDemail@example.com|
|Contact: Ahmad NSAIR, MDfirstname.lastname@example.org|
|St Etienne, France, 42055|
|Contact: Frédéric ROCHE, PhD +33477828300 email@example.com|
|Principal Investigator: Frédéric ROCHE, PhD|
|Sub-Investigator: Jean-Claude BARTHELEMY, PhD|
|Sub-Investigator: Isabelle COURT-FORTUNE, MD|
|Principal Investigator:||Frédéric ROCHE, MD||CHU SAINT-ETIENNE|