Integrated Management of Chronic Respiratory Diseases — eMEUSE-SANTE  

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title: Integrated Management of Chronic Respiratory Diseases - eMEUSE-SANTE

Status Recruiting

Clinical Trial 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).

Clinical Trial 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). ;

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Respiration Disorders
• Respiratory Tract Diseases
• Sleep Apnea, Obstructive

• NCT number: NCT04963192
• Study type: Interventional
• Source: University Hospital, Grenoble
• Contact: Marie JOYEUX-FAURE, PharmD, PhD
• Phone: 334 767 692 65
• Email: mjoyeuxfaure@chu-grenoble.fr
• Status: Recruiting
• Phase: N/A
• Start date: September 10, 2021
• Completion date: February 28, 2025