Trained Patient Involvement to Promote the Resumption of CPAP in Patients Who Have Discontinued Its Use
Primary Purpose
Obstructive Sleep Apnea Syndrome
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
peer-driven intervention
Sponsored by
About this trial
This is an interventional other trial for Obstructive Sleep Apnea Syndrome focused on measuring Sleep Apnea, CPAP adherence, Patient and Public Involvement (PPI), cognitive-behavioural and motivation enhancement therapies, Patient Involvement (PI)
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)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Patient researcher intervention
Usual care
Arm Description
Intervention conducted by trained patient researchers to restart CPAP in addition to usual care
Usual care
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
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
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
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
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
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.
Feasibility and the execution of the peer-driven intervention
Evaluate the feasibility and the execution of the peer-driven intervention
Age
This variable will be used to assess predictors of positive response to patient researcher intervention
Gender
This variable will be used to assess predictors of positive response to patient researcher intervention
BMI Body Mass Index
This variable will be used to assess predictors of positive response to patient researcher intervention
marital status with infants (<10 years) or not
This variable will be used to assess predictors of positive response to patient researcher intervention
Education level
This variable will be used to assess predictors of positive response to patient researcher intervention
employment and socio-professional status
This variable will be used to assess predictors of positive response to patient researcher intervention
alcohol-smoking status
This variable will be used to assess predictors of positive response to patient researcher intervention
fragility and social precariousness
EPICES score will be used to assess predictors of positive response to patient researcher intervention
medication adherence
Girerd Score. This variable will be used to assess predictors of positive response to patient researcher intervention
OSA history
date of diagnosis of OSA
CPAP treatment
Date of initiation of CPAP and date and cause of CPAP discontinuation
Baseline Apnea-Hypopnea Index (AHI)
This variable will be used to assess predictors of positive response to patient researcher intervention
Excessive daytime sleepiness (EDS score)
Epworth Sleepiness Scale will be used to assess predictors of positive response to patient researcher intervention
Comorbidities
Charlson index will be used to assess predictors of positive response to patient researcher intervention
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04538274
Brief Title
Trained Patient Involvement to Promote the Resumption of CPAP in Patients Who Have Discontinued Its Use
Official Title
A Peer-driven Intervention to Help Patients Resume CPAP Therapy Following Discontinuation: a Multicenter, Randomized Clinical Trial With Patient Involvement
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2021 (Anticipated)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
February 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AGIR à Dom
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea Syndrome
Keywords
Sleep Apnea, CPAP adherence, Patient and Public Involvement (PPI), cognitive-behavioural and motivation enhancement therapies, Patient Involvement (PI)
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is a prospective, multicentre, randomized controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
208 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patient researcher intervention
Arm Type
Experimental
Arm Description
Intervention conducted by trained patient researchers to restart CPAP in addition to usual care
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Usual care
Intervention Type
Behavioral
Intervention Name(s)
peer-driven intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Evaluate the impact of a 6-month, peer-driven intervention to promote the resumption of CPAP after discontinuation
Description
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 Outcome Measure Information:
Title
Evaluate the impact of the peer-driven intervention on adherence to CPAP compared to the control group
Description
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
Title
Evaluate the impact of the peer-driven intervention on adherence to CPAP compared to the control group
Description
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
Title
Disease-specific quality of life
Description
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
Title
Patient Self-Efficacy Measure for Sleep Apnea
Description
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
Title
Patient knowledge, skill, and confidence for self-management
Description
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
Time Frame
At inclusion and after 6 months
Title
Patient satisfaction and peer satisfaction
Description
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.
Time Frame
At 6 month after inclusion
Title
Feasibility and the execution of the peer-driven intervention
Description
Evaluate the feasibility and the execution of the peer-driven intervention
Time Frame
At 6 month after inclusion
Title
Age
Description
This variable will be used to assess predictors of positive response to patient researcher intervention
Time Frame
inclusion
Title
Gender
Description
This variable will be used to assess predictors of positive response to patient researcher intervention
Time Frame
inclusion
Title
BMI Body Mass Index
Description
This variable will be used to assess predictors of positive response to patient researcher intervention
Time Frame
inclusion
Title
marital status with infants (<10 years) or not
Description
This variable will be used to assess predictors of positive response to patient researcher intervention
Time Frame
inclusion
Title
Education level
Description
This variable will be used to assess predictors of positive response to patient researcher intervention
Time Frame
inclusion
Title
employment and socio-professional status
Description
This variable will be used to assess predictors of positive response to patient researcher intervention
Time Frame
inclusion
Title
alcohol-smoking status
Description
This variable will be used to assess predictors of positive response to patient researcher intervention
Time Frame
inclusion
Title
fragility and social precariousness
Description
EPICES score will be used to assess predictors of positive response to patient researcher intervention
Time Frame
inclusion
Title
medication adherence
Description
Girerd Score. This variable will be used to assess predictors of positive response to patient researcher intervention
Time Frame
inclusion
Title
OSA history
Description
date of diagnosis of OSA
Time Frame
inclusion
Title
CPAP treatment
Description
Date of initiation of CPAP and date and cause of CPAP discontinuation
Time Frame
inclusion
Title
Baseline Apnea-Hypopnea Index (AHI)
Description
This variable will be used to assess predictors of positive response to patient researcher intervention
Time Frame
inclusion
Title
Excessive daytime sleepiness (EDS score)
Description
Epworth Sleepiness Scale will be used to assess predictors of positive response to patient researcher intervention
Time Frame
inclusion
Title
Comorbidities
Description
Charlson index will be used to assess predictors of positive response to patient researcher intervention
Time Frame
inclusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christophe Pison, MD
Phone
04 76 76 54 53
Ext
+33
Email
CPison@chu-grenoble.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Raymon Merle
Email
raymond.merle38@gmail.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
34649850
Citation
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.
Results Reference
derived
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Trained Patient Involvement to Promote the Resumption of CPAP in Patients Who Have Discontinued Its Use
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