Ignite Creation Date:
2025-12-24 @ 3:56 PM
Ignite Modification Date:
2025-12-26 @ 4:44 AM
Study NCT ID:
NCT04963192
Status:
RECRUITING
Last Update Posted:
2024-01-03
First Post:
2021-06-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Integrated Management of Chronic Respiratory Diseases
Sponsor:
University Hospital, Grenoble
Organization:
Study Overview
Official Title:
Integrated Management of Chronic Respiratory Diseases - eMEUSE-SANTE
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
eMEUSE-SANTE
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).
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).
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).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 38RC21.149 | OTHER | Grenoble Alpes University Hospital | View |