Trained Patient Involvement to Promote the Resumption of CPAP in Patients Who Have Discontinued Its Use

Official title

A Peer-driven Intervention to Help Patients Resume CPAP Therapy Following Discontinuation: a Multicenter, Randomized Clinical Trial with Patient Involvement

Overview

The primary objective of this randomized clinical trial is to evaluate the role of patient researchers in promoting the resumption of CPAP therapy in apneic patients who had previously stopped CPAP

Detailed description

Obstructive Sleep Apnoea syndrome (OSA) is one of the most frequent chronic disease presenting with or without symptoms of excessive daytime sleepiness (EDS) and being accompanied by neurocognitive, cardiovascular and metabolic complications.

The first line therapy of obstructive sleep apnoea is continuous positive airway pressure (CPAP). CPAP is highly effective in symptomatic patients for reducing EDS and improving daily functioning, cognitive function, mood and quality of life. However, success of CPAP treatment is hampered by long term nonadherence in nearly half of patients. Non adherence to CPAP is less and less related to technical problems, but rather to users' profile, their representations of OSA and the benefits experienced from CPAP. Cognitive-behavioural and motivation enhancement therapies can promote adherence to CPAP treatment. In addition to health professionals, patients and public involvement (PPI) is more and more advocated in the field of education and research. Nevertheless, the level of evidence regarding efficacy of PPI and patient researchers remains to be demonstrated. The aim of this randomized clinical trial is to evaluate the role of patient researchers in promoting the resumption of CPAP therapy in apneic patients who had previously stopped CPAP

Interventions

• Behavioral peer-driven intervention
  Trained patient researchers will conduct 3 motivational sessions, according to the principle of motivational enhancement and cognitive-behavioral therapies, by videoconference meetings of 45 to 60 minutes duration with 5 to 8 patients within 6 months after each patient's inclusion.

Primary outcome measures

• Evaluate the impact of a 6-month, peer-driven intervention to promote the resumption of CPAP after discontinuation [Time frame: 6 months after inclusion]

Secondary outcome measures (12)

• Evaluate the impact of the peer-driven intervention on adherence to CPAP compared to the control group [Time frame: 6 month after inclusion]
• Evaluate the impact of the peer-driven intervention on adherence to CPAP compared to the control group [Time frame: 6 month after inclusion]
• Disease-specific quality of life [Time frame: At inclusion and after 6 months]
• Patient Self-Efficacy Measure for Sleep Apnea [Time frame: At inclusion and after 6 months]
• Patient knowledge, skill, and confidence for self-management [Time frame: At inclusion and after 6 months]
• Patient satisfaction and peer satisfaction [Time frame: At 6 month after inclusion]
• Feasibility and the execution of the peer-driven intervention [Time frame: At 6 month after inclusion]
• Age [Time frame: inclusion]
• Gender [Time frame: inclusion]
• BMI Body Mass Index [Time frame: inclusion]
• marital status with infants (<10 years) or not [Time frame: inclusion]
• Education level [Time frame: inclusion]

Eligibility criteria

Inclusion criteria

• Over 18 years old
• Diagnosed with of severe OSA (AHI ≥ 30 events/hour)
• Discontinuation of CPAP 4 to 12 months after initiation Followed by the home health care provider Agiradom
• Access to a computer and/or tablet and an internet connection
• Oral and written French
• Able to provide written informed consent
• Affiliated to social security or beneficiary of such a scheme

Exclusion criteria

• CPAP cessation due to a resolution of the OSAS (e.g. weight loss after bariatric surgery) or another pathology that prevents the continuation of treatment (e.g. ENT surgery, etc.).
• Severe and/or unstable comorbidity that required hospitalisation for decompensation in the previous year (heart, kidney, respiratory, liver, psychiatric or other insufficiency).
• Patient being treated with a mandibular advancement orthosis
• Lack of availability (e.g. night worker or patient who travels frequently, etc.).
• Current participation in, participation in the month prior to inclusion in another clinical intervention research study that may impact the study: this impact is left to the investigator's discretion.
• Referred to in Articles L1121-5 to L1121-8 of the CSP (corresponds to all protected persons: pregnant woman, breastfeeding mother, person deprived of liberty by judicial or administrative decision, person subject to a legal protection measure)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Other

Study locations

Center list to be confirmed — check the primary protocol.

Publications

• Merle R, Pison C, Logerot S, Deschaux C, Arnol N, Roustit M, Tamisier R, Pepin JL, Borel JC. Peer-driven intervention to help patients resume CPAP therapy following discontinuation: a multicentre, randomised clinical trial with patient involvement. BMJ Open. 2021 Oct 14;11(10):e053996. doi: 10.1136/bmjopen-2021-053996. PMID 34649850

Identifiers

NCT: NCT04538274 · 2020-06

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗