Image

Integrated Management of Chronic Respiratory Diseases

Integrated Management of Chronic Respiratory Diseases

Recruiting
18-75 years
All
Phase N/A

Powered by AI

Overview

Chronic respiratory diseases such as obstructive sleep apnea syndrome (OSA) and chronic obstructive pulmonary disease (COPD) constitute a major public health problem, due to their high prevalence, but especially because of their cardiovascular and metabolic morbidity and mortality and the associated costs for the health system. The organization of long-term management of these diseases is now part of the e-health process, digital health with the use of massive "big data" generated by care and follow-up. Therapeutic patient education and the integration of connected objects will allow personalized therapeutic education support with interventions by local medical staff adapted to the needs of the patients.

This will also allow to objectify the effect of treatments such as continuous positive airway pressure (CPAP) for OSA or non-invasive ventilation (NIV) and/or oxygen therapy for COPD, not only on the prevention of respiratory decompensation but also on cardiovascular and metabolic risk factors which are major elements of the prognosis. This project will therefore make it possible to demonstrate the feasibility and to deploy a multi-actor care pathway in the territory.

The investigators propose a prospective clinical study, conducted at the Verdun Hospital, with the main objective of studying the evolution of the quality of life of patients with a chronic respiratory pathology, during an integrated management at home for 6 months.

The secondary objectives:

  • To study the evolution of the following parameters, before treatment (at inclusion) and after 6 months of integrated management:
    1. Treatment compliance (CPAP or NIV/oxygen therapy)
    2. Physical activity
    3. Weight
    4. Mean arterial pressure
    5. Oxygen saturation, heart rate and respiratory rate for COPD patients
    6. Severity of COPD for the patients concerned
    7. Daytime sleepiness
    8. Fatigue
    9. Patient acceptability of the use of connected objects
  • To analyze the trajectories of the measures collected throughout the integrated management to identify specific profiles.
  • To analyze the daily data of the different connected objects and treatments with regard to the patients' profiles (according to age, gender, comorbidities, OSA or COPD group).

Description

Chronic respiratory diseases such as obstructive sleep apnea syndrome (OSA) and chronic obstructive pulmonary disease (COPD) constitute a major public health problem, due to their high prevalence, but especially because of their cardiovascular and metabolic morbidity and mortality and the associated costs for the health system. There is also an inequality of access to referral care linked to demographics and territorial organization. We are currently at a turning point in the understanding of these pathologies and their coordinated management by combining therapeutic modalities. The organization of long-term management of these diseases is now part of the e-health process, digital health with the use of massive "big data" generated by care and follow-up. Therapeutic patient education and the integration of connected objects measuring weight, oxygen saturation rate, heart rate, respiratory rate, skin temperature blood pressure or physical activity will allow personalized therapeutic education support with interventions by local medical staff adapted to the needs of the patients.

This will also allow to objectify the effect of treatments such as continuous positive airway pressure (CPAP) for OSA or non-invasive ventilation (NIV) and/or oxygen therapy for COPD, not only on the prevention of respiratory decompensation but also on cardiovascular and metabolic risk factors which are major elements of the prognosis. This project will therefore make it possible to demonstrate the feasibility and to deploy a multi-actor care pathway in the territory.

The investigators propose a prospective clinical study, conducted at the Verdun Hospital, with the main objective of studying the evolution of the quality of life of patients with a chronic respiratory pathology, during an integrated management at home for 6 months.

The secondary objectives:

  • To study the evolution of the following parameters, before treatment (at inclusion) and after 6 months of integrated management:
    1. Treatment compliance (CPAP or NIV/oxygen therapy)
    2. Physical activity, measured by an actimeter for OSAS patients or by the BORA Band device for COPD patients, for one week and IPAQ
    3. Weight, measured by a connected scale
    4. Average blood pressure, measured by a connected blood pressure monitor
    5. Oxygen saturation, heart rate and respiratory rate measured by the BORA Band for COPD patients
    6. The severity of COPD by the EXASCORE questionnaire for the patients concerned
    7. Daytime sleepiness by the Epworth questionnaire
    8. Fatigue by the Pichot scale
    9. Patients' acceptability of the use of the connected objects by questionnaires of satisfaction of use at 6 months.
  • To analyze the trajectories of the measures collected throughout the integrated management to identify specific profiles.
  • To analyze the daily data of the different connected objects and treatments with regard to the patients' profiles (according to age, gender, comorbidities, OSA or COPD group).

Eligibility

Inclusion Criteria:

  • Patient with a chronic respiratory pathology such as:
  • Newly diagnosed OSA with indication for CPAP treatment
  • And/or COPD with or without indication for NIV/oxygen therapy
  • Have a smartphone (with Android or iOS) allowing the installation of applications for connected objects
  • Be able to use a mobile application on a personal smartphone
  • Person agreeing to the telemonitoring of CPAP or NIV/oxygen therapy compliance data by the healthcare provider
  • Patient who has provided consent to participate in the study
  • Person affiliated to the social security

Exclusion Criteria:

  • Pregnant or breastfeeding woman
  • Patient unable to give consent to participate in the study
  • Patient under guardianship or curatorship
  • Patient not affiliated to the social security system
  • Patient deprived of liberty or hospitalized
  • Patient protected by law
  • Patient under administrative or judicial control
  • Patient currently participating in another clinical research study that may have an impact on the study, this impact is left to the discretion of the investigator

Study details
    Sleep Apnea
    Obstructive
    Chronic Obstructive Pulmonary Disease

NCT04963192

University Hospital, Grenoble

27 January 2024

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.