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Trial record 1 of 1 for:    NCT02435355
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Efficiency of a Phone Coaching for Sleep Apnea Hypopnea Syndrome Patients

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ClinicalTrials.gov Identifier: NCT02435355
Recruitment Status : Completed
First Posted : May 6, 2015
Last Update Posted : May 6, 2015
Sponsor:
Information provided by (Responsible Party):
Sadir Association

Brief Summary:

Background: Continuous Positive Airway Pressure (CPAP) remains the reference treatment for moderate to severe forms of the Sleep Apnea/Hypopnea Syndrome (SAHS). Compliance to the treatment appears to be a key factor to improving health status of these patients.

Methods: The investigators conducted a multicenter, prospective, randomized, controlled, parallel group trial of standard support completed or not within 3 months of coaching sessions for newly diagnosed SAHS patients starting CPAP therapy. The coaching session consisted of 5 sessions of telephone-based counseling by competent staff. The primary outcome was the proportion of patients using CPAP more than 3 hours per night for 4 months; the secondary outcome was mean hours of CPAP usage in the 2 groups.


Condition or disease Intervention/treatment Phase
Sleep Apnea Syndromes Behavioral: telephone-based counselling Not Applicable

Detailed Description:

We conducted a multicenter, prospective, randomized, controlled, parallel group trial of standard support versus phone coaching for newly diagnosed SAHS patients starting CPAP therapy. Patients for clinical polysomnographic evaluation were recruited from April 2010 to March 2012. Those who were subsequently diagnosed with SAHS and prescribed CPAP were included in the study. The patient population was then randomized into two groups, one that received standard CPAP support only and the other standard support completed by a coaching session.

Procedure Standard support All patients in this study underwent this procedure, which is the regular procedure in France. In short, the patient received information by their physician, about modalities and usefulness of CPAP treatment. In the week following this information, a technician from the home care provider (SADIR based in France) brought CPAP equipment to the home, re-explained the device function and checked the mask adaptation to the patient. The follow-up of the patient by the home care provider consisted of one visit at home the first month to check the mask's tolerance and the functioning of the machine. An other visit was performed after 4 months to assess CPAP parameters (length of use, mask leaks, and residual AHI). Sleep physician checked the compliance and efficiency of CPAP treatment once the first month, then at 3 and 6 months. The compliance was then assessed by patient questioning and by looking at the data registered by the machine. After this period, the medical follow up was performed once a year.

Coached group In the coached group (CG), patients received standard support completed by 5 sessions (day 3, 10, 30, 60, 90 with equipment at home) of telephone-based counselling session by competent staff. Sessions were performed by a qualified person in education, qualifies by a university degree (Paul Sabatier University, Toulouse, France). The dates of phone calls were planned with the patient availabilities.

The objective of the first session was to assess the patient's knowledge about the disease, device and health consequences. The importance of good adherence was emphasized, encouraging the patients to use the CPAP device throughout sleep every day. Objectives of the other educational sessions were first to identify disadvantages or obstacles to follow CPAP treatment and then focus on the benefits linked to use of CPAP. A particular effort was made to discuss misconceptions about sleep apnea and barriers to use, concerns fears and beliefs, as well as the perceptions of their partners and family, in order to increase patients' positive expectations regarding CPAP benefits. The qualified person in education could also refer any problems in links with SAHS encountered by the patient to the technician, psychologist or dietician (employed by the home care provider). They can respectively help the patient with CPAP technical advice, mentally blocked with CPAP or diet counseling. The average length of each phone call was approximately 15 to 20 minutes.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 379 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Efficiency of a Phone Coaching Program on Adherence to Continuous Positive Airway Pressure in Sleep Apnea Hypopnea Syndrome
Study Start Date : April 2010
Actual Primary Completion Date : August 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
No Intervention: standard support
All patients in this study underwent this procedure, which is the regular procedure in France.
Experimental: coached group
In the coached group (CG), patients received standard support completed by 5 sessions (day 3, 10, 30, 60, 90 with equipment at home) of telephone-based counselling session by competent staff. Sessions were performed by a qualified person in education, qualifies by a university degree (Paul Sabatier University, Toulouse, France). The dates of phone calls were planned with the patient availabilities.
Behavioral: telephone-based counselling
The objective of the first session was to assess the patient's knowledge about the disease, device and health consequences. The importance of good adherence was emphasized, encouraging the patients to use the CPAP device throughout sleep every day. Objectives of the other educational sessions were first to identify disadvantages or obstacles to follow CPAP treatment and then focus on the benefits linked to use of CPAP. A particular effort was made to discuss misconceptions about sleep apnea and barriers to use, concerns fears and beliefs, as well as the perceptions of their partners and family, in order to increase patients' positive expectations regarding CPAP benefits.




Primary Outcome Measures :
  1. proportion of patients using Continuous Positive Airway Pressure for more than 3 hours per night in the 2 groups [ Time Frame: CPAP use was evaluated for 4 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • newly diagnosed with SAHS
  • CPAP treatment prescribed

Exclusion Criteria:

  • previously use CPAP
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sadir Association
ClinicalTrials.gov Identifier: NCT02435355    
Other Study ID Numbers: Sadir Association
First Posted: May 6, 2015    Key Record Dates
Last Update Posted: May 6, 2015
Last Verified: April 2015
Keywords provided by Sadir Association:
Sleep apnea
education
compliance
CPAP
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Syndrome
Disease
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases