Peer-driven intervention to help patients resume CPAP therapy following discontinuation: a multicentre, randomised clinical trial with patient involvement

Raymond Merle, Christophe Pison, Sophie Logerot, Chrystèle Deschaux, Nathalie Arnol, Matthieu Roustit, Renaud Tamisier, Jean Louis Pépin, Jean Christian Borel, Raymond Merle, Christophe Pison, Sophie Logerot, Chrystèle Deschaux, Nathalie Arnol, Matthieu Roustit, Renaud Tamisier, Jean Louis Pépin, Jean Christian Borel

Abstract

Introduction: Obstructive sleep apnoea syndrome (OSAS) is one of the most common chronic diseases. It may be associated with symptoms of excessive daytime sleepiness and neurocognitive and cardiovascular complications. First line therapy for OSAS involves home continuous positive airway pressure (CPAP), however, nearly half of patients do not adhere with this treatment over the long term. Cognitive-behavioural interventions that include health professionals and patient and public involvement are increasingly advocated in the fields of education and research. We hypothesise that a peer-driven intervention could help patients with OSAS to resume CPAP use after discontinuation.

Methods and analysis: We have designed a prospective, multicentre randomised, controlled trial that will be coconducted by health professionals, a home provider of CPAP and patients as experts or peers or participants. The primary aim is to evaluate the impact of a 6-month, peer-driven intervention to promote the resumption of CPAP after discontinuation. We anticipate that 20% of patients in the intervention group will reuse CPAP as compared with 6% in control group, thus, 104 patients must be included in each group. The secondary aims are (1) to evaluate the impact of the peer-driven intervention on adherence to CPAP compared with the control group (mean adherence and percentage of nights with at least 4 hours' use/night for 70% of nights); (2) to determine factors associated with resumption of CPAP; (3) to assess patient satisfaction with the peer-driven intervention at 6 months; (4) to evaluate the feasibility and the execution of the peer-driven intervention and peer satisfaction. Adult outpatients with an established diagnosis of severe OSA (Apnoea-Hypopnoea Index >30 events/hour) that have stopped using CPAP within 4-12 months after initiation will be recruited. The peers who will perform the intervention will be patients with OSAS treated with CPAP with good adherence (at least 4 hours/night, 70% of nights) and trained in motivational enhancement and cognitive-behavioural therapies. Trained peers will conduct three interviews within 6 months with participants.

Ethics and dissemination: Ethical approval has been obtained from the French Regional Ethics Committee CPP Ouest II-Angers, (IRB 21.02.25.68606 (2021/2025)). All participants will sign written informed consent. The results will be presented at conferences and published in peer-reviewed journals as well as public media.

Trial registration number: NCT04538274.

Keywords: chronic airways disease; respiratory medicine (see thoracic medicine); sleep medicine.

Conflict of interest statement

Competing interests: RM is a recipient of a grant from Agir pour les Maladies Chroniques, http://fonds-apmc.org/. CD, NA, JCB are employees of AGIR à dom. CP and JLP received grants from Agir pour les Maladies Chroniques, http://fonds-apmc.org/.

© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ.

Figures

Figure 1
Figure 1
Study design. CPAP, continuous positive airway pressure; PI, patient involvement; PPI, patient and public involvement. e-CRF, electronic-Clinical Record Form.

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