Integrated Management of Chronic Respiratory Diseases - eMEUSE-SANTE

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other, Device
Study Type: Interventional
Study Phase: Not Applicable
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
Grenoble Alpes University Hospital
ENROLLING_BY_INVITATION
Grenoble
Verdun Hospital
RECRUITING
Verdun
Contact Information
Primary
Marie JOYEUX-FAURE, PharmD, PhD
mjoyeuxfaure@chu-grenoble.fr
334 767 692 65
Backup
Robin TERRAIL, MBA
rterrail@chu-grenoble.fr
334 767 671 66
Time Frame
Start Date: 2021-09-10
Estimated Completion Date: 2025-02-28
Participants
Target number of participants: 400
Treatments
Experimental: OSA or COPD patients having an integrated management at home
OSA or COPD patients having an integrated management at home using connected devices, during 6 months
Sponsors
Collaborators: BIOSENCY compagny, eMeuse-Santé consortium, SEFAM compagnie, PULSY - Regional Support Group for the Development of e-health, EFCR Department and Sleep Laboratory, Grenoble Alpes University Hospital, ADOR - Territorial Support Network, Device and Tools for Primary Care Teams, Pneumology Department, Verdun Hospital
Leads: University Hospital, Grenoble

This content was sourced from clinicaltrials.gov