NCT04963192

Integrated Management of Chronic Respiratory Diseases

Integrated Management of Chronic Respiratory Diseases - eMEUSE-SANTE

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: University Hospital, Grenoble · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Detailed 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).

Conditions

• Sleep Apnea, Obstructive
• Chronic Obstructive Pulmonary Disease

Interventions

Type	Name	Description
DEVICE	Connected actimeter to measure physical activity in OSA patients	Connected actimeter worn for one week before initiation of treatment, at M3 and at M6, to measure average daily steps for OSA patients
DEVICE	Connected BORA Band to measure physical activity in COPD patients only	Connected BORA Band worn for one week before initiation of treatment, at M3 and at M6, to measure average daily steps for COPD patients only
OTHER	IPAQ to evaluated physical activity	Physical activity evaluated by IPAQ (International Physical Activity Questionnaire) at the inclusion, M3 and M6
DEVICE	Connected scale to measure weight	Weight measured by a connected scale, before CPAP or NIV treatment, at M3 and M6
DEVICE	Connected tensiometer to measure arterial pressure	Arterial pressure measured by a connected tensiometer, before CPAP or NIV treatment, at M3 and M6
DEVICE	Connected BORA Band to measure oxygen saturation in COPD patients only	Daily oxygen saturation measured by the connected BORA Band for COPD patients only during 6 months
DEVICE	Connected BORA Band to measure heart rate in COPD patients only	Daily heart rate measured by the connected BORA Band for COPD patients only during 6 months
DEVICE	Connected BORA Band to measure respiratory rate in COPD patients only	Daily respiratory rate measured by the connected BORA Band for COPD patients only during 6 months
OTHER	EXASCORE to evaluated COPD severity	COPD severity evaluated by the EXASCORE questionnaire at inclusion, M3 and M6 for COPD patients only
OTHER	Epworth scale to evaluate sleepiness	Sleepiness evaluated by the Epworth scale at baseline, M3 and M6
OTHER	Pichot scale to evaluate fatigue	Fatigue evaluated by the Pichot scale at inclusion, M3 and M6
OTHER	Usability questionnaire	Subjective assessment of each device by means of usability questionnaire at M6
OTHER	SF36 questionnaire	Quality of life evaluated by the SF36 questionnaire at inclusion and M6

Timeline

• Start date: 2021-09-10
• Primary completion: 2024-12-31
• Completion: 2025-02-28
• First posted: 2021-07-15
• Last updated: 2024-01-03

Locations

2 sites across 1 country: France