Visio-consultation Compared to Face-to-face Consultation During the Follow-up of Apneic Patients Treated by Continuous Positive Airway Pressure (CPAP)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Obstructive Sleep Apnea
- Sponsor
- University Hospital, Grenoble
- Enrollment
- 250
- Locations
- 1
- Primary Endpoint
- Consultation cost
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
Prospective multicenter open-label randomized clinical trial comparing videoconsultation to a face-to-face consultation during the follow-up of apneic patients treated by continuous positive pressure (CPAP) .
Detailed Description
The annual management of Obstructive Sleep Apnea (OSA) patients treated by continuous positive air pressure (CPAP) aims to maintain an optimal level of care while offering to the patients a combined management of their pathology. This management aims to reduce the risk of cardio-metabolic pathologies. However, the high prevalence of OSA in the general population reduces the ability to explore undiagnosed patients. The contribution of videoconsultation is now available and allows the management of OSA patients treated by CPAP. The objective of this study is to compare the videoconsultation to a face-to-face consultation during the follow-up of apneic patients treated by continuous positive pressure (CPAP) . The results of this study could provide very important new data on the impact of videoconsultation on the monitoring a chronic respiratory pathology such as sleep apnea.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Apneic patient treated with CPAP for more than 12 months and having an annual scheduled follow-up visit.
- •Adult patient who can give an informed consent.
- •Patient with access to a media (Smartphone, tablet or computer) and an Internet connection at home.
Exclusion Criteria
- •Patient unable to use or understand the digital system.
- •Patient under guardianship or deprived of liberty
- •Pregnant woman
- •Patient in a period of exclusion from another clinical trial
Outcomes
Primary Outcomes
Consultation cost
Time Frame: 3 months after consultation
Non inferiority of visioconsultation compared to face-to-face consultation in terms of consultation cost evaluated by the difference in cost between the 2 types of consultation
Therapeutic adherence to CPAP
Time Frame: 3 months after consultation
Non inferiority of visioconsultation compared to face-to-face consultation in terms of therapeutic adherence to CPAP evaluated by the difference in compliance 3 months before and 3 months after the consultation
Patient satisfaction: questionnaire
Time Frame: 3 months after consultation
Non inferiority of visioconsultation compared to face-to-face consultation in terms of patient satisfaction evaluated by the VSQ-VF questionnaire
Secondary Outcomes
- Sleepiness related to CPAP(3 and 12 after consultation)
- Tiredness related to CPAP(3 and 12 months after consultation)
- Evaluate the quality of CPAP treatment (Residual AHI)(3 and 12 months after consultation)
- Evaluate the quality of CPAP treatment (adverse events)(3 and 12 months after consultation)
- Evaluate the quality of CPAP treatment (mask leaks level)(3 and 12 months after consultation)
- Evaluate the quality of CPAP treatment (visits by the health care provider): number of visits by the health care provider and the reasons for these visits(3 and 12 months after consultation)
- Assess the risk factors associated with OSA in patients treated with CPAP (weight)(12 months after consultation)
- Assess the risk factors associated with OSA in patients treated with CPAP (blood pressure)(12 months after consultation)
- Assess the risk factors associated with OSA in patients treated with CPAP (level of physical activity)(12 months after consultation)