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

N/ANot Yet RecruitingNCT04538274

AGIR à Dom208 enrolled

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

208

Conditions

Obstructive Sleep Apnea Syndrome

Interventions

peer-driven interventionBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 120 Years

Medical Language ↔ Plain English

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

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.

Time frame: 6 months after inclusion

Secondary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: At inclusion and after 6 months

Patient knowledge, skill, and confidence for self-management

Central Contacts

Christophe Pison, MD

CONTACT

04 76 76 54 53 CPison@chu-grenoble.fr

Raymon Merle

CONTACT

raymond.merle38@gmail.com

Data from ClinicalTrials.gov

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