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Integrated Management of Chronic Respiratory Diseases (eMEUSE-SANTE)

Primary Purpose

Sleep Apnea, Obstructive, Chronic Obstructive Pulmonary Disease

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Connected actimeter to measure physical activity in OSA patients
Connected BORA Band to measure physical activity in COPD patients only
IPAQ to evaluated physical activity
Connected scale to measure weight
Connected tensiometer to measure arterial pressure
Connected BORA Band to measure oxygen saturation in COPD patients only
Connected BORA Band to measure heart rate in COPD patients only
Connected BORA Band to measure respiratory rate in COPD patients only
EXASCORE to evaluated COPD severity
Epworth scale to evaluate sleepiness
Pichot scale to evaluate fatigue
Usability questionnaire
SF36 questionnaire
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Sleep Apnea, Obstructive

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Grenoble Alpes University Hospital
  • Verdun HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

OSA or COPD patients having an integrated management at home

Arm Description

OSA or COPD patients having an integrated management at home using connected devices, during 6 months

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change of Physical activity (average daily steps) for OSA patient only
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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

Full Information

First Posted
June 21, 2021
Last Updated
June 9, 2022
Sponsor
University Hospital, Grenoble
Collaborators
EFCR Department and Sleep Laboratory, Grenoble Alpes University Hospital, Pneumology Department, Verdun Hospital, BIOSENCY compagny, SEFAM compagnie, ADOR - Territorial Support Network, Device and Tools for Primary Care Teams, PULSY - Regional Support Group for the Development of e-health, eMeuse-Santé consortium
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1. Study Identification

Unique Protocol Identification Number
NCT04963192
Brief Title
Integrated Management of Chronic Respiratory Diseases
Acronym
eMEUSE-SANTE
Official Title
Integrated Management of Chronic Respiratory Diseases - eMEUSE-SANTE
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 10, 2021 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
February 28, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble
Collaborators
EFCR Department and Sleep Laboratory, Grenoble Alpes University Hospital, Pneumology Department, Verdun Hospital, BIOSENCY compagny, SEFAM compagnie, ADOR - Territorial Support Network, Device and Tools for Primary Care Teams, PULSY - Regional Support Group for the Development of e-health, eMeuse-Santé consortium

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: 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).
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: 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea, Obstructive, Chronic Obstructive Pulmonary Disease

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
OSA or COPD patients having an integrated management at home
Arm Type
Experimental
Arm Description
OSA or COPD patients having an integrated management at home using connected devices, during 6 months
Intervention Type
Device
Intervention Name(s)
Connected actimeter to measure physical activity in OSA patients
Intervention Description
Connected actimeter worn for one week before initiation of treatment, at M3 and at M6, to measure average daily steps for OSA patients
Intervention Type
Device
Intervention Name(s)
Connected BORA Band to measure physical activity in COPD patients only
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
IPAQ to evaluated physical activity
Intervention Description
Physical activity evaluated by IPAQ (International Physical Activity Questionnaire) at the inclusion, M3 and M6
Intervention Type
Device
Intervention Name(s)
Connected scale to measure weight
Intervention Description
Weight measured by a connected scale, before CPAP or NIV treatment, at M3 and M6
Intervention Type
Device
Intervention Name(s)
Connected tensiometer to measure arterial pressure
Intervention Description
Arterial pressure measured by a connected tensiometer, before CPAP or NIV treatment, at M3 and M6
Intervention Type
Device
Intervention Name(s)
Connected BORA Band to measure oxygen saturation in COPD patients only
Intervention Description
Daily oxygen saturation measured by the connected BORA Band for COPD patients only during 6 months
Intervention Type
Device
Intervention Name(s)
Connected BORA Band to measure heart rate in COPD patients only
Intervention Description
Daily heart rate measured by the connected BORA Band for COPD patients only during 6 months
Intervention Type
Device
Intervention Name(s)
Connected BORA Band to measure respiratory rate in COPD patients only
Intervention Description
Daily respiratory rate measured by the connected BORA Band for COPD patients only during 6 months
Intervention Type
Other
Intervention Name(s)
EXASCORE to evaluated COPD severity
Intervention Description
COPD severity evaluated by the EXASCORE questionnaire at inclusion, M3 and M6 for COPD patients only
Intervention Type
Other
Intervention Name(s)
Epworth scale to evaluate sleepiness
Intervention Description
Sleepiness evaluated by the Epworth scale at baseline, M3 and M6
Intervention Type
Other
Intervention Name(s)
Pichot scale to evaluate fatigue
Intervention Description
Fatigue evaluated by the Pichot scale at inclusion, M3 and M6
Intervention Type
Other
Intervention Name(s)
Usability questionnaire
Intervention Description
Subjective assessment of each device by means of usability questionnaire at M6
Intervention Type
Other
Intervention Name(s)
SF36 questionnaire
Intervention Description
Quality of life evaluated by the SF36 questionnaire at inclusion and M6
Primary Outcome Measure Information:
Title
Change of Quality of life assessed by the SF36 questionnaire
Description
Change of quality of life, assessed by the SF36 questionnaire, from Baseline (at inclusion) and after 6 months of an integrated management at home
Time Frame
at inclusion and at 6 months
Secondary Outcome Measure Information:
Title
Change of Physical activity (average daily steps) for OSA patient only
Description
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
Time Frame
One week before initiation of CPAP treatment and at Month 3 and Month 6
Title
Change of Physical activity (average daily steps) for COPD patient only
Description
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
Time Frame
One week before initiation of NIV treatment and at Month 3 and Month 6
Title
Change of Physical activity assessed by the IPAQ questionnaire
Description
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
Time Frame
At the inclusion, Month 3 and Month 6
Title
Change of Weight measured by a connected scale
Description
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.
Time Frame
Before CPAP or NIV treatment, at Month 3 and Month 6
Title
Change of Arterial pressure measured by a connected tensiometer
Description
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.
Time Frame
Before CPAP or NIV treatment, at Month 3 and Month 6
Title
Daily oxygen saturation measured by the connected BORA Band for COPD patients only
Description
Daily oxygen saturation measured by the connected BORA Band for COPD patients only
Time Frame
During 6 months
Title
Daily heart rate measured by the connected BORA Band for COPD patients only
Description
Daily heart rate measured by the connected BORA Band for COPD patients only
Time Frame
During 6 months
Title
Daily respiratory rate measured by the connected BORA Band for COPD patients only
Description
Daily respiratory rate measured by the connected BORA Band for COPD patients only
Time Frame
During 6 months
Title
Change of COPD severity evaluated by the EXASCORE questionnaire for COPD patients only
Description
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.
Time Frame
At the inclusion, Month 3 and Month 6
Title
Change of Sleepiness evaluated by the Epworth questionnaire
Description
Change of Sleepiness evaluated by the Epworth questionnaire, from Baseline (at inclusion), and after 3 and 6 months of an integrated management at home.
Time Frame
At baseline, Month 3 and Month 6
Title
Change of Fatigue evaluated by the Pichot questionnaire
Description
Change of Fatigue evaluated by the Pichot questionnaire, from Baseline (at inclusion), and after 3 and 6 months of an integrated management at home.
Time Frame
At inclusion, Month 3 and Month 6
Title
Satisfaction and usage of the connected scale assessed by a specific questionnaire
Description
Satisfaction and usage of the connected scale assessed by a specific questionnaire, after 6 months of an integrated management at home
Time Frame
At Month 6
Title
Satisfaction and usage of the connected tensiometer assessed by a specific questionnaire
Description
Satisfaction and usage of the connected tensiometer assessed by a specific questionnaire, after 6 months of an integrated management at home
Time Frame
At Month 6
Title
Satisfaction and usage of the connected actimeter assessed by a specific questionnaire, for OSA patients only
Description
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
Time Frame
At Month 6
Title
Satisfaction and usage of the connected BORA Band assessed by a specific questionnaire, for COPD patients only
Description
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
Time Frame
At Month 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marie JOYEUX-FAURE, PharmD, PhD
Phone
334 767 692 65
Email
mjoyeuxfaure@chu-grenoble.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Robin TERRAIL, MBA
Phone
334 767 671 66
Email
rterrail@chu-grenoble.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Louis PEPIN, MD, PhD
Organizational Affiliation
Grenoble Alpes University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Grenoble Alpes University Hospital
City
Grenoble
ZIP/Postal Code
38000
Country
France
Individual Site Status
Enrolling by invitation
Facility Name
Verdun Hospital
City
Verdun
ZIP/Postal Code
55100
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Murielle PARENT
Email
mparent1@ch-verdun.fr
First Name & Middle Initial & Last Name & Degree
Céline CARDOSO-PARMENTIER, nurse
Email
ccardoso@ch-verdun.fr
First Name & Middle Initial & Last Name & Degree
Jean-Claude CORNU, MD
First Name & Middle Initial & Last Name & Degree
Khier AMRANI, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Integrated Management of Chronic Respiratory Diseases

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