A Peer-driven Intervention to Help Patients Resume CPAP Therapy Following Discontinuation: a Multicenter, Randomized Clinical Trial with Patient Involvement
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Obstructive Sleep Apnea Syndrome
- Sponsor
- AGIR à Dom
- Enrollment
- 208
- Primary Endpoint
- Evaluate the impact of a 6-month, peer-driven intervention to promote the resumption of CPAP after discontinuation
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
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
Investigators
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)
Outcomes
Primary Outcomes
Evaluate the impact of a 6-month, peer-driven intervention to promote the resumption of CPAP after discontinuation
Time Frame: 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 Outcomes
- OSA history(inclusion)
- Age(inclusion)
- Comorbidities(inclusion)
- Feasibility and the execution of the peer-driven intervention(At 6 month after inclusion)
- marital status with infants (<10 years) or not(inclusion)
- Education level(inclusion)
- medication adherence(inclusion)
- Gender(inclusion)
- employment and socio-professional status(inclusion)
- alcohol-smoking status(inclusion)
- Evaluate the impact of the peer-driven intervention on adherence to CPAP compared to the control group(6 month after inclusion)
- Patient Self-Efficacy Measure for Sleep Apnea(At inclusion and after 6 months)
- Patient knowledge, skill, and confidence for self-management(At inclusion and after 6 months)
- Patient satisfaction and peer satisfaction(At 6 month after inclusion)
- fragility and social precariousness(inclusion)
- CPAP treatment(inclusion)
- Disease-specific quality of life(At inclusion and after 6 months)
- BMI Body Mass Index(inclusion)
- Excessive daytime sleepiness (EDS score)(inclusion)
- Baseline Apnea-Hypopnea Index (AHI)(inclusion)