Efficiency of a Phone Coaching for Sleep Apnea Hypopnea Syndrome Patients

NCT02435355 | Completed

• 1 other identifier: Sadir Association
• Study Type: interventional
• Target: 379
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Sleep Apnea Syndromes

Keywords

Sleep apnea; education; compliance; CPAP

Outcome Measures

Primary Outcomes (1)

• proportion of patients using Continuous Positive Airway Pressure for more than 3 hours per night in the 2 groups

  CPAP use was evaluated for 4 months

Study Arms (2)

standard support

NO INTERVENTION

All patients in this study underwent this procedure, which is the regular procedure in France.

coached group

EXPERIMENTAL

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

Interventions

telephone-based counselling BEHAVIORAL

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.

coached group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• newly diagnosed with SAHS
• CPAP treatment prescribed

You may not qualify if:

• previously use CPAP

Sponsors & Collaborators

• Sadir Association: lead

Related Publications (1)

• Sedkaoui K, Leseux L, Pontier S, Rossin N, Leophonte P, Fraysse JL, Didier A. Efficiency of a phone coaching program on adherence to continuous positive airway pressure in sleep apnea hypopnea syndrome: a randomized trial. BMC Pulm Med. 2015 Sep 14;15:102. doi: 10.1186/s12890-015-0099-7.

  PMID: 26370444 DERIVED

MeSH Terms

Conditions

Sleep Apnea Syndromes; Patient Compliance

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2015
• First Posted: May 6, 2015
• Study Start: April 1, 2010
• Primary Completion: August 1, 2012
• Study Completion: October 1, 2012
• Last Updated: May 6, 2015

Record last verified: 2015-04