Integrated Management of Chronic Respiratory Diseases (eMEUSE-SANTE)

  • STATUS
    Recruiting
  • End date
    Feb 28, 2025
  • participants needed
    400
  • sponsor
    University Hospital, Grenoble
Updated on 30 June 2022

Summary

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).

Details
Condition Sleep Apnea, Obstructive, Chronic Obstructive Pulmonary Disease
Treatment SF36 questionnaire, Connected actimeter to measure physical activity in OSA patients, Connected BORA Band to measure physical activity in COPD patients only, IPAQ to evaluated physical activity, Connected scale to measure weight, Connected tensiometer to measure arterial pressure, Connected BORA Band to measure oxygen saturation in COPD patients only, Connected BORA Band to measure heart rate in COPD patients only, Connected BORA Band to measure respiratory rate in COPD patients only, EXASCORE to evaluated COPD severity, Epworth scale to evaluate sleepiness, Pichot scale to evaluate fatigue, Usability questionnaire
Clinical Study IdentifierNCT04963192
SponsorUniversity Hospital, Grenoble
Last Modified on30 June 2022

Eligibility

Yes No Not Sure

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
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