NCT03591250

Brief Summary

Health care renunciation is a factor that can alter patients' health status and increase the costs of its support. To date, there is no national data on the renunciation of care. This study will initially characterize the different forms of health care renunciation in patients with chronic respiratory diseases, treated with continuous positive airway pressure (CPAP) or non-invasive ventilation (NIV) , and analyze it impact on treatment compliance and health processes. The follow-up of these patients during 5 years will define renunciation trajectories (transition from the state of "renouncing" to "non-renouncing" and vice versa) and their impact on treatment compliance. The investigators hypothesize that a patient becoming renounced on a given treatment also decreases his treatment compliance (CPAP or NIV ). The impact of the renunciation trajectory on the patient's follow-up in terms of hospitalizations and deaths will also be studied.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,083

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2018

Typical duration for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 1, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 19, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

December 7, 2018

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 29, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 29, 2022

Completed
Last Updated

January 3, 2024

Status Verified

January 1, 2024

Enrollment Period

3.7 years

First QC Date

June 1, 2018

Last Update Submit

January 2, 2024

Conditions

Obstructive Sleep ApneaRespiratory Failure

Keywords

Healthcare renunciationContinuous positive airway pressureNon-invasive ventilation

Outcome Measures

Primary Outcomes (1)

  • Treatment compliance to CPAP or NIV

    Extracted from the database of AGIR à dom

    Baseline and 1 year

Secondary Outcomes (12)

  • Age (years)

    Baseline and 1 year

  • Gender (male/female)

    Baseline

  • Type of housing (urban , peri-urban or non-urban)

    Baseline and 1 year

  • Type of pathology (OSAS, Respiratory failure)

    Baseline and 1 year

  • Number of hospitalizations per year

    Baseline and 1 year

  • +7 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with chronic respiratory diseases treated for at least 12 months by CPAP, NIV therapy and monitored by AGIR à dom.

You may qualify if:

  • Male or female over 18 years old
  • Patient with respiratory failure or obstructive sleep apnea
  • Treated with CPAP, NIV therapy for at least 12 months
  • Home monitoring by AGIR a dom
  • Voluntary patient to participate in research after adequate information and delivery of the information note
  • Patient affiliated with social security or beneficiary of such a scheme

You may not qualify if:

  • Pregnant, lactating or parturient woman
  • Person deprived of liberty by judicial or administrative decision, person subject to a measure of legal protection (patient under tutorship or curatorship) Article L1121-8

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

EFCR HP2 Laboratory

Grenoble, Auvergne-Rhône-Alpes, 38000, France

Location

Bruno LEPAULE

Échirolles, 38130, France

Location

Centre Santé Sommeil

Grenoble, 38000, France

Location

Related Publications (4)

  • Senaratna CV, Perret JL, Lodge CJ, Lowe AJ, Campbell BE, Matheson MC, Hamilton GS, Dharmage SC. Prevalence of obstructive sleep apnea in the general population: A systematic review. Sleep Med Rev. 2017 Aug;34:70-81. doi: 10.1016/j.smrv.2016.07.002. Epub 2016 Jul 18.

    PMID: 27568340BACKGROUND

  • Deniz S, Sengul A, Aydemir Y, Celdir Emre J, Ozhan MH. Clinical factors and comorbidities affecting the cost of hospital-treated COPD. Int J Chron Obstruct Pulmon Dis. 2016 Dec 2;11:3023-3030. doi: 10.2147/COPD.S120637. eCollection 2016.

    PMID: 27980399BACKGROUND

  • Borel JC, Pepin JL, Pison C, Vesin A, Gonzalez-Bermejo J, Court-Fortune I, Timsit JF. Long-term adherence with non-invasive ventilation improves prognosis in obese COPD patients. Respirology. 2014 Aug;19(6):857-65. doi: 10.1111/resp.12327. Epub 2014 Jun 9.

    PMID: 24912564BACKGROUND

  • Daabek N, Tamisier R, Foote A, Revil H, Joyeux-Jaure M, Pepin JL, Bailly S, Borel JC. Impact of Healthcare Non-Take-Up on Adherence to Long-Term Positive Airway Pressure Therapy. Front Public Health. 2021 Aug 17;9:713313. doi: 10.3389/fpubh.2021.713313. eCollection 2021.

    PMID: 34485235DERIVED

MeSH Terms

Conditions

Sleep Apnea, ObstructiveRespiratory Insufficiency

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2018

First Posted

July 19, 2018

Study Start

December 7, 2018

Primary Completion

August 29, 2022

Study Completion

August 29, 2022

Last Updated

January 3, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(3)