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

NCT ID: NCT05653804

Last Updated: 2023-07-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-01
• Study Completion Date: 2027-04-01

Brief Summary

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

Detailed 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.

Conditions

Obstructive Sleep Apnea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

tele-visit by HCP

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

Group Type: EXPERIMENTAL

tele-visit

Intervention Type: PROCEDURE

The remote visit content for CPAP follow up is based on home visit framework and carried out from a secure platform for sharing health data.

home visit by HCP

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

tele-visit

The remote visit content for CPAP follow up is based on home visit framework and carried out from a secure platform for sharing health data.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AGIR à Dom

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean Christian BOREL, PhD

Role: PRINCIPAL_INVESTIGATOR

AGIR à Dom

Locations

AGIR à dom.

Meylan, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Pauline Socquet

Role: CONTACT

p.socquet@agiradom.com

0763236615

Facility Contacts

Pauline PERINET MARQUET

Role: primary

p.perinet-marquet@agiradom.com

Other Identifiers

2022-A02309-34

Identifier Type: -

Identifier Source: org_study_id