Integrated Management of Chronic Respiratory Diseases

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).

Conditions

• Sleep Apnea, Obstructive
• Chronic Obstructive Pulmonary Disease

Interventions

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

Sponsors & Collaborators

• EFCR Department and Sleep Laboratory, Grenoble Alpes University Hospital

  collaborator UNKNOWN

• Pneumology Department, Verdun Hospital

  collaborator UNKNOWN

• BIOSENCY compagny

  collaborator UNKNOWN

• SEFAM compagnie

  collaborator UNKNOWN

• ADOR - Territorial Support Network, Device and Tools for Primary Care Teams

  collaborator UNKNOWN

• PULSY - Regional Support Group for the Development of e-health

  collaborator UNKNOWN

• eMeuse-Santé consortium

  collaborator UNKNOWN

• University Hospital, Grenoble

  lead OTHER

Principal Investigators

• Jean-Louis PEPIN, MD, PhD · Grenoble Alpes University Hospital

Study Design

Allocation

NA

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-09-10

Primary Completion

2024-12-31

Completion

2025-02-28

Countries

• France

Study Locations