Healthcare Renunciation in Patient With Respiratory Chronic Disease and Treatment Compliance
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 1,083
- Locations
- 3
- Primary Endpoint
- Treatment compliance to CPAP or NIV
Study Overview
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.
Detailed Description
A questionnaire of health care renunciation will be administered to the patient at Day 0 and each year during 5 years, to determine whether or not he has given up one or more care in the last 12 months.
The compliance to the CPAP or NIV will be extracted from the database of the Health care provider (AGIR à dom).
The primary outcome is to determine the impact of health care renunciation on treatment compliance and overall health care processes.
The analysis of the primary outcome (compliance) will be performed using a simple or generalized linear model (based on its observed distribution). Variables most associated with compliance will be introduced into a multivariate model, including healthcare renunciation variables.
For the secondary objective (identifying the determinants of cessation of health care) a first approach based on unsupervised learning will make it possible to classify patients according to homogeneous profiles on the basis of the different information collected.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Treatment compliance to CPAP or NIV
Time Frame: Baseline and 1 year
Extracted from the database of AGIR à dom
Secondary Outcomes
- Age (years)(Baseline and 1 year)
- BMI (Kg/m^2)(Baseline and 1 year)
- Gender (male/female)(Baseline)
- Epworth Sleepiness Scale (ESS)(Baseline and 1 year)
- Type of housing (urban , peri-urban or non-urban)(Baseline and 1 year)
- Type of pathology (OSAS, Respiratory failure)(Baseline and 1 year)
- Family situation The modalities of this variables are : - Alone - Alone with dependent children - Couples without dependent children - Couples with dependent children(Baseline and 1 year)
- Type of health insurance(Baseline and 1 year)
- Presence or absence and nature of complementary health insurance(Baseline and 1 year)
- Number of hospitalizations per year(Baseline and 1 year)
- Socio-Professional Category(Baseline and 1 year)
- AHI (event/hour)(Baseline and 1 year)