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

Obstructive Sleep Apnea Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04538274
• Other study ID #: 2020-06
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2021
• Est. completion date: February 2024

Study information

• Verified date: May 2021
• Source: AGIR à Dom
• Contact: Christophe Pison, MD
• Phone: 04 76 76 54 53
• Email: CPison[@]chu-grenoble.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Other known NCT identifiers

• NCT04774692

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 208
• Est. completion date: February 2024
• Est. primary completion date: September 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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)

Related Conditions & MeSH terms

• Obstructive Sleep Apnea Syndrome
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AGIR à Dom

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Age	This variable will be used to assess predictors of positive response to patient researcher intervention	inclusion
Secondary	Gender	This variable will be used to assess predictors of positive response to patient researcher intervention	inclusion
Secondary	BMI Body Mass Index	This variable will be used to assess predictors of positive response to patient researcher intervention	inclusion
Secondary	marital status with infants (<10 years) or not	This variable will be used to assess predictors of positive response to patient researcher intervention	inclusion
Secondary	Education level	This variable will be used to assess predictors of positive response to patient researcher intervention	inclusion
Secondary	employment and socio-professional status	This variable will be used to assess predictors of positive response to patient researcher intervention	inclusion
Secondary	alcohol-smoking status	This variable will be used to assess predictors of positive response to patient researcher intervention	inclusion
Secondary	fragility and social precariousness	EPICES score will be used to assess predictors of positive response to patient researcher intervention	inclusion
Secondary	medication adherence	Girerd Score. This variable will be used to assess predictors of positive response to patient researcher intervention	inclusion
Secondary	OSA history	date of diagnosis of OSA	inclusion
Secondary	CPAP treatment	Date of initiation of CPAP and date and cause of CPAP discontinuation	inclusion
Secondary	Baseline Apnea-Hypopnea Index (AHI)	This variable will be used to assess predictors of positive response to patient researcher intervention	inclusion
Secondary	Excessive daytime sleepiness (EDS score)	Epworth Sleepiness Scale will be used to assess predictors of positive response to patient researcher intervention	inclusion
Secondary	Comorbidities	Charlson index will be used to assess predictors of positive response to patient researcher intervention	inclusion