NCT03591250|Completed
Healthcare Renunciation in Respiratory Chronic Disease and Treatment Compliance (OBSERVE)
OBSERVE
Healthcare Renunciation in Patient With Respiratory Chronic Disease and Treatment Compliance
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OBSERVE
Healthcare Renunciation in Patient With Respiratory Chronic Disease and Treatment Compliance
Sponsor study identifier
Secondary identifiers
OTHER · ID RCB
observational
1,083
1 country
3
Study Start
December 7, 2018
Actual (reported)Primary Completion
August 29, 2022
Actual (reported)Study Completion
August 29, 2022
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 29, 2022
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 1, 2018
Actual (reported)July 19, 2018
Actual (reported)December 7, 2018
Actual (reported)August 29, 2022
Actual (reported)August 29, 2022
Actual (reported)Treatment compliance to CPAP or NIV
Extracted from the database of AGIR à dom
Baseline and 1 year
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
Patients with chronic respiratory diseases treated for at least 12 months by CPAP, NIV therapy and monitored by AGIR à dom.
EFCR HP2 Laboratory
Grenoble, Auvergne-Rhône-Alpes, 38000, France
Bruno LEPAULE
Échirolles, 38130, France
Centre Santé Sommeil
Grenoble, 38000, France
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.
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.
1,083 participants (actual enrollment reported by the registry).
First Submitted
June 1, 2018
First Posted
July 19, 2018
Study Start
December 7, 2018
Actual (reported)Follow-up of Apneic Patients by Visio-consultation
Contact the study team to confirm eligibility.
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.
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.
Primary Completion
August 29, 2022
Actual (reported)Study Completion
August 29, 2022
Actual (reported)Last Updated
January 3, 2024
Record last verified: 2024-01
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Source: ClinicalTrials.gov.
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