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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Obstructive Sleep Apnea Syndrome
• Intervention / Treatment: Behavioral: peer-driven intervention

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

• Study Type: Interventional
• Enrollment (Anticipated): 208
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christophe Pison, MD; Phone Number: +33 04 76 76 54 53; Email: CPison@chu-grenoble.fr
• Study Contact Backup: Name: Raymon Merle; Email: raymond.merle38@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual care
Experimental: Patient researcher intervention; Intervention conducted by trained patient researchers to restart CPAP in addition to usual care	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: AGIR à Dom

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2021
• Primary Completion (Anticipated): September 1, 2023
• Study Completion (Anticipated): February 1, 2024

Study Registration Dates

• First Submitted: August 14, 2020
• First Submitted That Met QC Criteria: August 28, 2020
• First Posted (Actual): September 4, 2020

Study Record Updates

• Last Update Posted (Actual): June 1, 2021
• Last Update Submitted That Met QC Criteria: May 27, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Sleep Apnea; CPAP adherence; Patient and Public Involvement (PPI); cognitive-behavioural and motivation enhancement therapies; Patient Involvement (PI)
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
• Other Study ID Numbers: 2020-06

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No