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Obstructive Sleep ApneaOBSERVENCT03591250

Healthcare Renunciation in Respiratory Chronic Disease and Treatment Compliance (OBSERVE)

An observational study of Obstructive Sleep Apnea and Respiratory Failure, run by University Hospital, Grenoble at 3 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Obstructive Sleep Apnea, Respiratory Failure
How many people
1,083 participants
Where
3 sitesFrance
Study dates
7 Dec 2018to 29 Aug 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

3 sites in 1 country.

France3 sites

  • Bruno LEPAULE

    Échirolles, 38130

  • EFCR HP2 Laboratory

    Grenoble, Auvergne-Rhône-Alpes, 38000

  • Centre Santé Sommeil

    Grenoble, 38000

Other trials in France

About this study

Official title: Healthcare Renunciation in Patient With Respiratory Chronic Disease and Treatment Compliance

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.

Read more

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.

Read the 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.

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

Keywords
Healthcare renunciation, Continuous positive airway pressure, Non-invasive ventilation
Medical subject headings
Sleep Apnea, Obstructive, Respiratory Insufficiency

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Treatment compliance to CPAP or NIV

    Extracted from the database of AGIR à dom

    Measured: Baseline and 1 year

Secondary outcomes (12)

  1. Age (years)

    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.

    Measured: Baseline and 1 year

  2. Gender (male/female)

    This variable will be used to characterize the different forms of health care renunciation and analyze its impact on treatment compliance and overall care

    Measured: Baseline

  3. Type of housing (urban , peri-urban or non-urban)

    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

    Measured: Baseline and 1 year

  4. Type of pathology (OSAS, Respiratory failure)

    This variable will be used to characterize the different forms of health care renunciation and analyze its impact on treatment compliance and overall care

    Measured: Baseline and 1 year

  5. Number of hospitalizations per 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

    Measured: Baseline and 1 year

  6. BMI (Kg/m^2)

    This variable will be used to characterize the different forms of health care renunciation and analyze its impact on treatment compliance and overall care

    Measured: Baseline and 1 year

  7. Epworth Sleepiness Scale (ESS)

    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

    Measured: Baseline and 1 year

  8. AHI (event/hour)

    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.

    Measured: Baseline and 1 year

  9. Socio-Professional Category

    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.

    Measured: Baseline and 1 year

  10. Family situation The modalities of this variables are : - Alone - Alone with dependent children - Couples without dependent children - Couples with dependent children

    This variable will be used to characterize the different forms of health care renunciation and analyze its impact on treatment compliance and overall care

    Measured: Baseline and 1 year

  11. Type of health insurance

    This variable will be used to characterize the different forms of health care renunciation and analyze its impact on treatment compliance and overall care

    Measured: Baseline and 1 year

  12. Presence or absence and nature of complementary health insurance

    This variable will be used to characterize the different forms of health care renunciation and analyze its impact on treatment compliance and overall care

    Measured: Baseline and 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jul 2018
  2. Study start7 Dec 2018
  3. Primary completion29 Aug 2022
  4. Study completion29 Aug 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,083 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03591250
Sponsor's protocol ID
38RC17.321
Other IDs
2017-A02831-52
Acronym
OBSERVE
Status last verified
Jan 2024
First submitted
1 Jun 2018
Last updated
3 Jan 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 27568340

  • 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.

    PubMed 27980399

  • 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.

    PubMed 24912564

  • 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.

    PubMed 34485235

Questions about this trial

What is this clinical trial studying?

An observational study of Obstructive Sleep Apnea and Respiratory Failure, run by University Hospital, Grenoble at 3 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment compliance to CPAP or NIV (time frame: Baseline and 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03591250, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2024.

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