Impact of Tele-visit on Patients Continous Positive Airway Pressure (CPAP) Follow-up by Home Care Provider (i-tech PPC)

AGIR à Dom

Status: Enrolling

Conditions: Obstructive Sleep Apnea

Treatments: Procedure: tele-visit

Study type: Interventional

Funder types: Other

Identifiers

NCT05653804

2022-A02309-34

Details and patient eligibility

About

To determine the impact of telecare on continous positive airway pressure (CPAP) patients follow up by home care provider (HCP)

Full description

Obstructive sleep apnea (OSA) syndrome is a chronic respiratory pathology affecting 4% of french adult population and reference treatment for moderate to severe forms of obstructive sleep apnea syndrome (OSA) is continuous positive airway pressure (CPAP).

However, CPAP treatment is binding, so nearly a quarter of patients abandoning treatment at 1 year and nearly half of them at 3 years. Support for these patients on CPAP must therefore be optimal and seek patient satisfaction; HCP (Home Care Provider) plays an important role in this follow-up.

Since 2018 in France, teleconsultation entered on common law but was little used. The pandemic has disrupted the habits of care and patients monitoring by developing remote monitoring. Home Care Providers (HCP) have also been forced to organize remote monitoring, particularly for the annual follow-up visit (technical tele-visit).

The impact of the annual follow-up visits of HCP by tele-visit has never been clinically evaluated. If its clinical relevance were demonstrated and patient satisfaction confirmed, this follow-up modality could become, like telecare, a new standard for the follow-up of patients on CPAP.

Enrollment: 250 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 18 years
• CPAP ≥ 12 months and annual followed by "AGIR à dom" health care provider.
• Compliance with CPAP ≥ 4h/night and AHI ≤ 5 events/hour on machine report for the 3 months prior to inclusion

Exclusion criteria

• Follow-up by AGIR à dom. for an other service than package F9.1 : CPAP follow-up and remote monitoring
• Unacceptable level of mask leakage
• Patient unavailable or willing to move within the next 12 months to an area not covered by AGIR à dom.
• Patient considered by the investigator to be unfit for a tele-visit

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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250 participants in 2 patient groups

tele-visit by HCP

Experimental group

Description:

Patients receive a annual CPAP remote visit by HCP technician, then home visit the following year

Treatment:

Procedure: tele-visit

home visit by HCP

No Intervention group

Description:

Standard care : patients receive an annual CPAP home visit by HCP technician