Clinical trial NCT04963192: Integrated Management of Chronic Respiratory Diseases
Official title: Integrated Management of Chronic Respiratory Diseases - eMEUSE-SANTE
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sleep Apnea, Obstructive
Chronic Obstructive Pulmonary Disease
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: EFCR Department and Sleep Laboratory, Grenoble Alpes University Hospital
name: Pneumology Department, Verdun Hospital
name: BIOSENCY compagny
name: SEFAM compagnie
name: ADOR - Territorial Support Network, Device and Tools for Primary Care Teams
name: PULSY - Regional Support Group for the Development of e-health
name: eMeuse-Santé consortium
First posted: 2021-07-15
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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
Primary purpose: SUPPORTIVE_CARE

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).

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

Primary outcomes:
measure: Change of Quality of life assessed by the SF36 questionnaire
timeFrame: at inclusion and at 6 months
Secondary outcomes:
measure: Change of Physical activity (average daily steps) for OSA patient only
timeFrame: One week before initiation of CPAP treatment and at Month 3 and Month 6
measure: Change of Physical activity (average daily steps) for COPD patient only
timeFrame: One week before initiation of NIV treatment and at Month 3 and Month 6
measure: Change of Physical activity assessed by the IPAQ questionnaire
timeFrame: At the inclusion, Month 3 and Month 6
measure: Change of Weight measured by a connected scale
timeFrame: Before CPAP or NIV treatment, at Month 3 and Month 6
measure: Change of Arterial pressure measured by a connected tensiometer
timeFrame: Before CPAP or NIV treatment, at Month 3 and Month 6
measure: Daily oxygen saturation measured by the connected BORA Band for COPD patients only
timeFrame: During 6 months
measure: Daily heart rate measured by the connected BORA Band for COPD patients only
timeFrame: During 6 months
measure: Daily respiratory rate measured by the connected BORA Band for COPD patients only
timeFrame: During 6 months
measure: Change of COPD severity evaluated by the EXASCORE questionnaire for COPD patients only
timeFrame: At the inclusion, Month 3 and Month 6
measure: Change of Sleepiness evaluated by the Epworth questionnaire
timeFrame: At baseline, Month 3 and Month 6
measure: Change of Fatigue evaluated by the Pichot questionnaire
timeFrame: At inclusion, Month 3 and Month 6
measure: Satisfaction and usage of the connected scale assessed by a specific questionnaire
timeFrame: At Month 6
measure: Satisfaction and usage of the connected tensiometer assessed by a specific questionnaire
timeFrame: At Month 6
measure: Satisfaction and usage of the connected actimeter assessed by a specific questionnaire, for OSA patients only
timeFrame: At Month 6
measure: Satisfaction and usage of the connected BORA Band assessed by a specific questionnaire, for COPD patients only
timeFrame: At Month 6
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Grenoble Alpes University Hospital
city: Verdun
country: France
facility: Verdun Hospital
Study officials:
affiliation: Grenoble Alpes University Hospital
name: Jean-Louis PEPIN, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: