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Integrated Management of Chronic Respiratory Diseases

Integrated Management of Chronic Respiratory Diseases - eMEUSE-SANTE

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04963192
Acronym
eMEUSE-SANTE
Enrollment
400
Registered
2021-07-15
Start date
2021-09-10
Completion date
2025-02-28
Last updated
2024-01-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep Apnea, Obstructive, Chronic Obstructive Pulmonary Disease

Brief 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).

Interventions

DEVICEConnected 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

DEVICEConnected 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

OTHERIPAQ to evaluated physical activity

Physical activity evaluated by IPAQ (International Physical Activity Questionnaire) at the inclusion, M3 and M6

DEVICEConnected scale to measure weight

Weight measured by a connected scale, before CPAP or NIV treatment, at M3 and M6

DEVICEConnected tensiometer to measure arterial pressure

Arterial pressure measured by a connected tensiometer, before CPAP or NIV treatment, at M3 and M6

DEVICEConnected 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

DEVICEConnected 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

DEVICEConnected 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

OTHEREXASCORE to evaluated COPD severity

COPD severity evaluated by the EXASCORE questionnaire at inclusion, M3 and M6 for COPD patients only

OTHEREpworth scale to evaluate sleepiness

Sleepiness evaluated by the Epworth scale at baseline, M3 and M6

OTHERPichot scale to evaluate fatigue

Fatigue evaluated by the Pichot scale at inclusion, M3 and M6

Subjective assessment of each device by means of usability questionnaire at M6

Quality of life evaluated by the SF36 questionnaire at inclusion and M6

Sponsors

EFCR Department and Sleep Laboratory, Grenoble Alpes University Hospital
CollaboratorUNKNOWN
Pneumology Department, Verdun Hospital
CollaboratorUNKNOWN
BIOSENCY compagny
CollaboratorUNKNOWN
SEFAM compagnie
CollaboratorUNKNOWN
ADOR - Territorial Support Network, Device and Tools for Primary Care Teams
CollaboratorUNKNOWN
PULSY - Regional Support Group for the Development of e-health
CollaboratorUNKNOWN
eMeuse-Santé consortium
CollaboratorUNKNOWN
University Hospital, Grenoble
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention model description

A prospective clinical study, conducted at the Verdun Hospital, in patients with a chronic respiratory pathology (OSA or COPD), including an integrated management at home using connected devices, during 6 months

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change of Quality of life assessed by the SF36 questionnaireat inclusion and at 6 monthsChange of quality of life, assessed by the SF36 questionnaire, from Baseline (at inclusion) and after 6 months of an integrated management at home

Secondary

MeasureTime frameDescription
Change of Physical activity (average daily steps) for COPD patient onlyOne week before initiation of NIV treatment and at Month 3 and Month 6Change of the physical activity using the connected BORA Band for COPD patients only, from Baseline (one week before treatment) and after 3 and 6 months of an integrated management at home
Change of Physical activity assessed by the IPAQ questionnaireAt the inclusion, Month 3 and Month 6Change of Physical activity assessed by the IPAQ (International Physical Activity Questionnaire), from Baseline (at inclusion) and after 3 and 6 months of an integrated management at home
Change of Weight measured by a connected scaleBefore CPAP or NIV treatment, at Month 3 and Month 6Change of Weight measured by a connected scale, from Baseline (before CPAP or NIV treatment), and after 3 and 6 months of an integrated management at home.
Change of Arterial pressure measured by a connected tensiometerBefore CPAP or NIV treatment, at Month 3 and Month 6Change of Arterial pressure measured by a connected tensiometer, from Baseline (before CPAP or NIV treatment), and after 3 and 6 months of an integrated management at home.
Daily oxygen saturation measured by the connected BORA Band for COPD patients onlyDuring 6 monthsDaily oxygen saturation measured by the connected BORA Band for COPD patients only
Daily heart rate measured by the connected BORA Band for COPD patients onlyDuring 6 monthsDaily heart rate measured by the connected BORA Band for COPD patients only
Daily respiratory rate measured by the connected BORA Band for COPD patients onlyDuring 6 monthsDaily respiratory rate measured by the connected BORA Band for COPD patients only
Change of Physical activity (average daily steps) for OSA patient onlyOne week before initiation of CPAP treatment and at Month 3 and Month 6Change of the physical activity using a connected actimeter for OSA patients only, from Baseline (one week before treatment) and after 3 and 6 months of an integrated management at home
Change of Sleepiness evaluated by the Epworth questionnaireAt baseline, Month 3 and Month 6Change of Sleepiness evaluated by the Epworth questionnaire, from Baseline (at inclusion), and after 3 and 6 months of an integrated management at home.
Change of Fatigue evaluated by the Pichot questionnaireAt inclusion, Month 3 and Month 6Change of Fatigue evaluated by the Pichot questionnaire, from Baseline (at inclusion), and after 3 and 6 months of an integrated management at home.
Satisfaction and usage of the connected scale assessed by a specific questionnaireAt Month 6Satisfaction and usage of the connected scale assessed by a specific questionnaire, after 6 months of an integrated management at home
Satisfaction and usage of the connected tensiometer assessed by a specific questionnaireAt Month 6Satisfaction and usage of the connected tensiometer assessed by a specific questionnaire, after 6 months of an integrated management at home
Satisfaction and usage of the connected actimeter assessed by a specific questionnaire, for OSA patients onlyAt Month 6Satisfaction and usage of the connected actimeter assessed by a specific questionnaire, for OSA patients only, after 6 months of an integrated management at home
Satisfaction and usage of the connected BORA Band assessed by a specific questionnaire, for COPD patients onlyAt Month 6Satisfaction and usage of the connected BORA Band assessed by a specific questionnaire, for COPD patients only, after 6 months of an integrated management at home
Change of COPD severity evaluated by the EXASCORE questionnaire for COPD patients onlyAt the inclusion, Month 3 and Month 6Change of COPD severity evaluated by the EXASCORE questionnaire for COPD patients only, from Baseline (at inclusion), and after 3 and 6 months of an integrated management at home.

Countries

France

Contacts

Primary ContactMarie JOYEUX-FAURE, PharmD, PhD
mjoyeuxfaure@chu-grenoble.fr334 767 692 65
Backup ContactRobin TERRAIL, MBA
rterrail@chu-grenoble.fr334 767 671 66

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026