Efficiency of a Phone Coaching for Sleep Apnea Hypopnea Syndrome Patients

May 5, 2015 updated by: Sadir Association

Efficiency of a Phone Coaching Program on Adherence to Continuous Positive Airway Pressure in Sleep Apnea Hypopnea Syndrome

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

379

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • newly diagnosed with SAHS
  • CPAP treatment prescribed

Exclusion Criteria:

  • previously use CPAP

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
CPAP use was evaluated for 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sadir Association

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

April 30, 2015

First Submitted That Met QC Criteria

May 5, 2015

First Posted (Estimate)

May 6, 2015

Study Record Updates

Last Update Posted (Estimate)

May 6, 2015

Last Update Submitted That Met QC Criteria

May 5, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Sadir Association

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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