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

NCT04538274 | Not Yet Recruiting

• 1 other identifier: 2020-06
• Study Type: interventional
• Target: 208
• Locations: 0 countries
• Sites: N/A

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

Conditions

Obstructive Sleep Apnea Syndrome

Keywords

Sleep Apnea; CPAP adherence; Patient and Public Involvement (PPI); cognitive-behavioural and motivation enhancement therapies; Patient Involvement (PI)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (21)

• Evaluate the impact of the peer-driven intervention on adherence to CPAP compared to the control group

  6 month after inclusion

• Evaluate the impact of the peer-driven intervention on adherence to CPAP compared to the control group

  6 month after inclusion

• Disease-specific quality of life

  At inclusion and after 6 months

• Patient Self-Efficacy Measure for Sleep Apnea

  At inclusion and after 6 months

• Patient knowledge, skill, and confidence for self-management

  At inclusion and after 6 months

Study Arms (2)

Patient researcher intervention

EXPERIMENTAL

Intervention conducted by trained patient researchers to restart CPAP in addition to usual care

Behavioral: peer-driven intervention

Usual care

NO INTERVENTION

Usual care

Interventions

peer-driven intervention BEHAVIORAL

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.

Patient researcher intervention

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.).
• 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)

Sponsors & Collaborators

• AGIR à Dom: lead

Related Publications (1)

• 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.

  PMID: 34649850 DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Sleep Apnea Syndromes; Patient Participation

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Central Study Contacts

Christophe Pison, MD

CONTACT

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

Raymon Merle

CONTACT

raymond.merle38@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a prospective, multicentre, randomized controlled trial

Study Record Dates

• First Submitted: August 14, 2020
• First Posted: September 4, 2020
• Study Start: February 18, 2025
• Primary Completion: February 18, 2025
• Study Completion: February 18, 2025
• Last Updated: February 20, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share