Healthcare Renunciation in Respiratory Chronic Disease and Treatment Compliance (OBSERVE) (OBSERVE)
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| ClinicalTrials.gov Identifier: NCT03591250 |
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Recruitment Status :
Active, not recruiting
First Posted : July 19, 2018
Last Update Posted : April 6, 2020
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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.
| Condition or disease |
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| Obstructive Sleep Apnea Respiratory Failure |
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.
A classical multivariate analysis using a hierarchical logistic regression model will quantify the weight of the different determinants in the renunciation of care. Finally, an exploratory approach based on structural equation models based on latent variables will be implemented to establish the direct and indirect relationships of the different qualitative determinants collected in the questionnaires on caregiving.
Regarding the longitudinal approach, this will be the subject of several analysis steps. Firstly, on an annual basis, a descriptive analysis will be carried out to investigate the determinants of the cessation of care according to the status of patients (renouncing or not renouncing) the previous year. Regarding the five-year follow-up, mixed models will be used to identify different trajectories of patients with regard to the renunciation of care from the initial follow-up and to study their impact on the prognosis at 5 years in terms of deaths and number hospitalizations
| Study Type : | Observational |
| Estimated Enrollment : | 300 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Healthcare Renunciation in Patient With Respiratory Chronic Disease and Treatment Compliance |
| Actual Study Start Date : | June 7, 2018 |
| Actual Primary Completion Date : | November 8, 2019 |
| Estimated Study Completion Date : | November 8, 2024 |
- Treatment compliance to CPAP or NIV [ Time Frame: Baseline and 1 year ]Extracted from the database of AGIR à dom
- Age (years) [ Time Frame: Baseline and 1 year ]This variable will be used to characterize the different forms of health care renunciation and analyze its impact on treatment compliance and overall care processes in patients with chronic respiratory diseases.
- Gender (male/female) [ Time Frame: Baseline ]This variable will be used to characterize the different forms of health care renunciation and analyze its impact on treatment compliance and overall care
- Type of housing (urban , peri-urban or non-urban) [ Time Frame: Baseline and 1 year ]This variable will be defined via the patient's address and used to characterize the different forms of health care renunciation and analyze its impact on treatment compliance and overall care
- Type of pathology (OSAS, Respiratory failure) [ Time Frame: Baseline and 1 year ]This variable will be used to characterize the different forms of health care renunciation and analyze its impact on treatment compliance and overall care
- Number of hospitalizations per year [ Time Frame: Baseline and 1 year ]This variable will be used to characterize the different forms of health care renunciation and analyze its impact on treatment compliance and overall care
- BMI (Kg/m^2) [ Time Frame: Baseline and 1 year ]This variable will be used to characterize the different forms of health care renunciation and analyze its impact on treatment compliance and overall care
- Epworth Sleepiness Scale (ESS) [ Time Frame: Baseline and 1 year ]
This scale range from 0 to 24 . ESS from 0 to 5 is interpreted as a lower normal daytime Sleepiness ESS from 6 to 10 is interpreted as a higher Normal Daytime Sleepiness ESS from 11 to 12 is interpreted as a mild Excessive Daytime Sleepiness ESS from 13 to 15 is interpreted as a moderate Excessive Daytime Sleepiness ESS from 16 to 24 is interpreted as a severe Excessive Daytime Sleepiness
This variable will be used to characterize the different forms of health care renunciation and analyze its impact on treatment compliance and overall care
- AHI (event/hour) [ Time Frame: Baseline and 1 year ]
This variable will be used to characterize the different forms of health care renunciation and analyze its impact on treatment compliance and overall care .
The interpretation of the score :
Score from 0 to 6: Good sleep; score 7 to 8: average; score> 9: Risk of pathological somnolence.
- Socio-Professional Category [ Time Frame: Baseline and 1 year ]
The modalities of the variables are :
- Farmers
- Craftsmen, traders and entrepreneurs
- Senior Managers and Professional Occupations
- Intermediate professions employees
- Workers
- Retired
- Other people without professional activity This variable will be used to characterize the different forms of health care renunciation and analyze its impact on treatment compliance and overall care.
- Family situation The modalities of this variables are : - Alone - Alone with dependent children - Couples without dependent children - Couples with dependent children [ Time Frame: Baseline and 1 year ]This variable will be used to characterize the different forms of health care renunciation and analyze its impact on treatment compliance and overall care
- Type of health insurance [ Time Frame: Baseline and 1 year ]This variable will be used to characterize the different forms of health care renunciation and analyze its impact on treatment compliance and overall care
- Presence or absence and nature of complementary health insurance [ Time Frame: Baseline and 1 year ]This variable will be used to characterize the different forms of health care renunciation and analyze its impact on treatment compliance and overall care
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03591250
| France | |
| EFCR HP2 Laboratory | |
| Grenoble, Rhone Alpes, France, 38000 | |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | University Hospital, Grenoble |
| ClinicalTrials.gov Identifier: | NCT03591250 |
| Other Study ID Numbers: |
38RC17.321 2017-A02831-52 ( Other Identifier: ID RCB ) |
| First Posted: | July 19, 2018 Key Record Dates |
| Last Update Posted: | April 6, 2020 |
| Last Verified: | April 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Healthcare renunciation Continuous positive airway pressure Non-invasive ventilation |
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Sleep Apnea, Obstructive Respiratory Insufficiency Chronic Disease Sleep Apnea Syndromes Apnea Respiration Disorders Respiratory Tract Diseases |
Sleep Disorders, Intrinsic Dyssomnias Sleep Wake Disorders Nervous System Diseases Disease Attributes Pathologic Processes |