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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Obstructive Sleep Apnea Syndrome

Intervention / Treatment
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* Behavioral: peer-driven intervention


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a prospective, multicentre, randomized controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patient researcher intervention<br>Intervention conducted by trained patient researchers to restart CPAP in addition to usual care | Behavioral: peer-driven intervention<br>* 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.<br>|
| No Intervention: Usual care<br>Usual care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the impact of a 6-month, peer-driven intervention to promote the resumption of CPAP after discontinuation | The range of patients reusing CPAP in the intervention group The difference in percentages of patients who reuse CPAP between the peer-driven intervention group and the control group. | 6 months after inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the impact of the peer-driven intervention on adherence to CPAP compared to the control group | the difference in CPAP compliance (average hours of use/night) between the AP intervention group and a control group | 6 month after inclusion | 
| Evaluate the impact of the peer-driven intervention on adherence to CPAP compared to the control group | the difference in percentages of patients who reuse to CPAP with at least 4 hours' use /night for 70% of nights | 6 month after inclusion | 
| Disease-specific quality of life | The Functional Outcomes of Sleep Questionnaire (FOSQ10) will be completed at inclusion (M0) and at the 6-month follow-up (M6). This variable will be used to assess predictors of positive response to patient researcher intervention | At inclusion and after 6 months | 
| Patient Self-Efficacy Measure for Sleep Apnea | The Self-Efficacy Measure for Sleep Apnea (SEMSA) questionnaire, a tool with strong psychometric properties and with the potential for identifying patient perceptions will be completed at inclusion (M0) and at the 6-month follow-up (M6). This variable will be used to assess predictors of positive response to patient researcher intervention | At inclusion and after 6 months | 
| Patient knowledge, skill, and confidence for self-management | The Patient Activation Measure (PAM) qestionnaire, a measure that assesses patient knowledge, skill, and confidence for self-management, will be completed at inclusion (M0) and at the 6-month follow-up (M6) This variable will be used to assess predictors of positive response to patient researcher intervention | At inclusion and after 6 months | 
| Patient satisfaction and peer satisfaction | Patient satisfaction with the peer-driven intervention at 6 months will be measured on a 4-point Likert scale : very dissatisfied, dissatisfied, satisfied, very satisfied. Satisfaction of PI representatives will be measured on a 4-point Likert scale: very dissatisfied, dissatisfied, satisfied, very satisfied. | At 6 month after inclusion | 
| Feasibility and the execution of the peer-driven intervention | Evaluate the feasibility and the execution of the peer-driven intervention | At 6 month after inclusion | 
| Age | This variable will be used to assess predictors of positive response to patient researcher intervention | inclusion | 
| Gender | This variable will be used to assess predictors of positive response to patient researcher intervention | inclusion | 
| BMI Body Mass Index | This variable will be used to assess predictors of positive response to patient researcher intervention | inclusion | 
| marital status with infants (<10 years) or not | This variable will be used to assess predictors of positive response to patient researcher intervention | inclusion | 
| Education level | This variable will be used to assess predictors of positive response to patient researcher intervention | inclusion | 
| employment and socio-professional status | This variable will be used to assess predictors of positive response to patient researcher intervention | inclusion | 
| alcohol-smoking status | This variable will be used to assess predictors of positive response to patient researcher intervention | inclusion | 
| fragility and social precariousness | EPICES score will be used to assess predictors of positive response to patient researcher intervention | inclusion | 
| medication adherence | Girerd Score. This variable will be used to assess predictors of positive response to patient researcher intervention | inclusion | 
| OSA history | date of diagnosis of OSA | inclusion | 
| CPAP treatment | Date of initiation of CPAP and date and cause of CPAP discontinuation | inclusion | 
| Baseline Apnea-Hypopnea Index (AHI) | This variable will be used to assess predictors of positive response to patient researcher intervention | inclusion | 
| Excessive daytime sleepiness (EDS score) | Epworth Sleepiness Scale will be used to assess predictors of positive response to patient researcher intervention | inclusion | 
| Comorbidities | Charlson index will be used to assess predictors of positive response to patient researcher intervention | inclusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sleep Apnea, CPAP adherence, Patient and Public Involvement (PPI), cognitive-behavioural and motivation enhancement therapies, Patient Involvement (PI)