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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
AGIR à Dom
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    August 14, 2020
    Last Updated
    May 27, 2021
    Sponsor
    AGIR à Dom
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    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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