Trained Patient Involvement to Promote the Resumption of CPAP in Patients Who Have Discontinued Its Use
- Conditions
- Obstructive Sleep Apnea Syndrome
- Interventions
- Behavioral: peer-driven intervention
- Registration Number
- NCT04538274
- Lead Sponsor
- AGIR à Dom
- Brief Summary
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
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 208
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Patient researcher intervention peer-driven intervention Intervention conducted by trained patient researchers to restart CPAP in addition to usual care
- Primary Outcome Measures
Name Time Method Evaluate the impact of a 6-month, peer-driven intervention to promote the resumption of CPAP after discontinuation 6 months after inclusion 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.
- Secondary Outcome Measures
Name Time Method Age inclusion This variable will be used to assess predictors of positive response to patient researcher intervention
Feasibility and the execution of the peer-driven intervention At 6 month after inclusion Evaluate the feasibility and the execution of the peer-driven intervention
marital status with infants (<10 years) or not inclusion This variable will be used to assess predictors of positive response to patient researcher intervention
Education level inclusion This variable will be used to assess predictors of positive response to patient researcher intervention
Comorbidities inclusion Charlson index will be used to assess predictors of positive response to patient researcher intervention
Gender inclusion This variable will be used to assess predictors of positive response to patient researcher intervention
employment and socio-professional status inclusion This variable will be used to assess predictors of positive response to patient researcher intervention
alcohol-smoking status inclusion This variable will be used to assess predictors of positive response to patient researcher intervention
Evaluate the impact of the peer-driven intervention on adherence to CPAP compared to the control group 6 month after inclusion the difference in percentages of patients who reuse to CPAP with at least 4 hours' use /night for 70% of nights
Patient Self-Efficacy Measure for Sleep Apnea At inclusion and after 6 months 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
Patient knowledge, skill, and confidence for self-management At inclusion and after 6 months 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
Patient satisfaction and peer satisfaction At 6 month after inclusion 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.CPAP treatment inclusion Date of initiation of CPAP and date and cause of CPAP discontinuation
Disease-specific quality of life At inclusion and after 6 months 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 interventionBMI Body Mass Index inclusion This variable will be used to assess predictors of positive response to patient researcher intervention
fragility and social precariousness inclusion EPICES score will be used to assess predictors of positive response to patient researcher intervention
medication adherence inclusion Girerd Score. This variable will be used to assess predictors of positive response to patient researcher intervention
OSA history inclusion date of diagnosis of OSA
Excessive daytime sleepiness (EDS score) inclusion Epworth Sleepiness Scale will be used to assess predictors of positive response to patient researcher intervention
Baseline Apnea-Hypopnea Index (AHI) inclusion This variable will be used to assess predictors of positive response to patient researcher intervention