Integrated Management of Chronic Respiratory Diseases

Chronic Obstructive Pulmonary Disease Clinical Trial

— eMEUSE-SANTE  

Official title:

Integrated Management of Chronic Respiratory Diseases - eMEUSE-SANTE

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04963192
• Other study ID #: 2021-A01126-35
• Secondary ID: 38RC21.149
• Status: Recruiting
• Phase: N/A
• Start date: September 10, 2021
• Est. completion date: February 28, 2025

Study information

• Verified date: January 2024
• Source: University Hospital, Grenoble
• Contact: Marie JOYEUX-FAURE, PharmD, PhD
• Phone: 334 767 692 65
• Email: mjoyeuxfaure[@]chu-grenoble.fr
• Is FDA regulated: No
• Study type: Interventional

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).

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: February 28, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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
• 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
• Connected tensiometer to measure arterial pressure
Arterial pressure measured by a connected tensiometer, before CPAP or NIV treatment, at M3 and M6
• 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
• 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
• 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
• Epworth scale to evaluate sleepiness
Sleepiness evaluated by the Epworth scale at baseline, M3 and M6
• Pichot scale to evaluate fatigue
Fatigue evaluated by the Pichot scale at inclusion, M3 and M6
• Usability questionnaire
Subjective assessment of each device by means of usability questionnaire at M6
• SF36 questionnaire
Quality of life evaluated by the SF36 questionnaire at inclusion and M6

Locations

Country	Name	City	State
France	Grenoble Alpes University Hospital	Grenoble
France	Verdun Hospital	Verdun

Sponsors (8)

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

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	at inclusion and at 6 months
Secondary	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	One week before initiation of CPAP treatment and at Month 3 and Month 6
Secondary	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	One week before initiation of NIV treatment and at Month 3 and Month 6
Secondary	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	At the inclusion, Month 3 and Month 6
Secondary	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.	Before CPAP or NIV treatment, at Month 3 and Month 6
Secondary	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.	Before CPAP or NIV treatment, at Month 3 and Month 6
Secondary	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	During 6 months
Secondary	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	During 6 months
Secondary	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	During 6 months
Secondary	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.	At the inclusion, Month 3 and Month 6
Secondary	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.	At baseline, Month 3 and Month 6
Secondary	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.	At inclusion, Month 3 and Month 6
Secondary	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	At Month 6
Secondary	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	At Month 6
Secondary	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	At Month 6
Secondary	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	At Month 6