Integrated Management of Chronic Respiratory Diseases (eMEUSE-SANTE)
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| ClinicalTrials.gov Identifier: NCT04963192 |
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Recruitment Status :
Recruiting
First Posted : July 15, 2021
Last Update Posted : June 10, 2022
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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:
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To study the evolution of the following parameters, before treatment (at inclusion) and after 6 months of integrated management:
- Treatment compliance (CPAP or NIV/oxygen therapy)
- Physical activity
- Weight
- Mean arterial pressure
- Oxygen saturation, heart rate and respiratory rate for COPD patients
- Severity of COPD for the patients concerned
- Daytime sleepiness
- Fatigue
- 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).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Sleep Apnea, Obstructive Chronic Obstructive Pulmonary Disease | Device: Connected actimeter to measure physical activity in OSA patients Device: Connected BORA Band to measure physical activity in COPD patients only Other: IPAQ to evaluated physical activity Device: Connected scale to measure weight Device: Connected tensiometer to measure arterial pressure Device: Connected BORA Band to measure oxygen saturation in COPD patients only Device: Connected BORA Band to measure heart rate in COPD patients only Device: Connected BORA Band to measure respiratory rate in COPD patients only Other: EXASCORE to evaluated COPD severity Other: Epworth scale to evaluate sleepiness Other: Pichot scale to evaluate fatigue Other: Usability questionnaire Other: SF36 questionnaire | Not Applicable |
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:
- Treatment compliance (CPAP or NIV/oxygen therapy)
- Physical activity, measured by an actimeter for OSAS patients or by the BORA Band device for COPD patients, for one week and IPAQ
- Weight, measured by a connected scale
- Average blood pressure, measured by a connected blood pressure monitor
- Oxygen saturation, heart rate and respiratory rate measured by the BORA Band for COPD patients
- The severity of COPD by the EXASCORE questionnaire for the patients concerned
- Daytime sleepiness by the Epworth questionnaire
- Fatigue by the Pichot scale
- 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).
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 400 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| 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 |
| Masking: | None (Open Label) |
| Primary Purpose: | Supportive Care |
| Official Title: | Integrated Management of Chronic Respiratory Diseases - eMEUSE-SANTE |
| Actual Study Start Date : | September 10, 2021 |
| Estimated Primary Completion Date : | December 31, 2024 |
| Estimated Study Completion Date : | February 28, 2025 |
| Arm | Intervention/treatment |
|---|---|
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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
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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 |
- Change of Quality of life assessed by the SF36 questionnaire [ Time Frame: at inclusion and at 6 months ]Change of quality of life, assessed by the SF36 questionnaire, from Baseline (at inclusion) and after 6 months of an integrated management at home
- Change of Physical activity (average daily steps) for OSA patient only [ Time Frame: One week before initiation of CPAP treatment and at Month 3 and Month 6 ]Change 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 Physical activity (average daily steps) for COPD patient only [ Time Frame: One week before initiation of NIV treatment and at Month 3 and Month 6 ]Change 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 questionnaire [ Time Frame: At the inclusion, Month 3 and Month 6 ]Change 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 scale [ Time Frame: Before CPAP or NIV treatment, at Month 3 and Month 6 ]Change 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 tensiometer [ Time Frame: Before CPAP or NIV treatment, at Month 3 and Month 6 ]Change 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 only [ Time Frame: During 6 months ]Daily oxygen saturation measured by the connected BORA Band for COPD patients only
- Daily heart rate measured by the connected BORA Band for COPD patients only [ Time Frame: During 6 months ]Daily heart rate measured by the connected BORA Band for COPD patients only
- Daily respiratory rate measured by the connected BORA Band for COPD patients only [ Time Frame: During 6 months ]Daily respiratory rate measured by the connected BORA Band for COPD patients only
- Change of COPD severity evaluated by the EXASCORE questionnaire for COPD patients only [ Time Frame: At the inclusion, Month 3 and Month 6 ]Change 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.
- Change of Sleepiness evaluated by the Epworth questionnaire [ Time Frame: At baseline, Month 3 and Month 6 ]Change 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 questionnaire [ Time Frame: At inclusion, Month 3 and Month 6 ]Change 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 questionnaire [ Time Frame: At Month 6 ]Satisfaction 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 questionnaire [ Time Frame: At Month 6 ]Satisfaction 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 only [ Time Frame: At Month 6 ]Satisfaction 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 only [ Time Frame: At Month 6 ]Satisfaction 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
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| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04963192
| Contact: Marie JOYEUX-FAURE, PharmD, PhD | 334 767 692 65 | mjoyeuxfaure@chu-grenoble.fr | |
| Contact: Robin TERRAIL, MBA | 334 767 671 66 | rterrail@chu-grenoble.fr |
| France | |
| Grenoble Alpes University Hospital | Enrolling by invitation |
| Grenoble, France, 38000 | |
| Verdun Hospital | Recruiting |
| Verdun, France, 55100 | |
| Contact: Murielle PARENT mparent1@ch-verdun.fr | |
| Contact: Céline CARDOSO-PARMENTIER, nurse ccardoso@ch-verdun.fr | |
| Sub-Investigator: Jean-Claude CORNU, MD | |
| Sub-Investigator: Khier AMRANI, MD | |
| Principal Investigator: | Jean-Louis PEPIN, MD, PhD | Grenoble Alpes University Hospital |
| Responsible Party: | University Hospital, Grenoble |
| ClinicalTrials.gov Identifier: | NCT04963192 |
| Other Study ID Numbers: |
2021-A01126-35 38RC21.149 ( Other Identifier: Grenoble Alpes University Hospital ) |
| First Posted: | July 15, 2021 Key Record Dates |
| Last Update Posted: | June 10, 2022 |
| Last Verified: | June 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Respiration Disorders Respiratory Tract Diseases Sleep Apnea, Obstructive Lung Diseases |
Sleep Apnea Syndromes Apnea Sleep Disorders, Intrinsic Dyssomnias Sleep Wake Disorders Nervous System Diseases |