Clinical trial NCT05653804: Impact of Tele-visit on Patients Continous Positive Airway Pressure (CPAP) Follow-up by Home Care Provider
Official title: Impact of Tele-visit Versus Home Visit by Home Care Provider on Compliance With Continuous Positive Airway Pressure (CPAP) Therapy of Patients With Obstructive Sleep Apnea Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obstructive Sleep Apnea
Keywords: tele-visit
Lead sponsor: AGIR à Dom
Sponsor class: OTHER
First posted: 2022-12-16
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, interventional, randomized controlled, open-label, single-center, multi-site
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: To compare CPAP compliance between the two management modalities
timeFrame: Over the 3 months (tele)visit follow-up
Secondary outcomes:
measure: To compare overall patient satisfaction between the two management modalities
timeFrame: Immediately after the (tele-)visit follow-up
measure: To compare the impact on daytime sleepiness between the two management modalities
timeFrame: At 3 months after (tele-)visit follow-up
measure: To compare impact on quality of life between the two management modalities
timeFrame: At 3 months after (tele-)visit follow-up
measure: To compare CPAP compliance in medium term between the two management modalities
timeFrame: Over the 12 months (tele)visit follow-up
measure: To compare impact on CPAP continuation between the two management modalities
timeFrame: Over the 12 months (tele)visit follow-up
measure: To compare treatment effectiveness between the two management modalities
timeFrame: Over the 12 months (tele)visit follow-up
measure: To compare treatment quality on mask leakage between the two management modalities
timeFrame: Over the 3 months (tele)visit follow-up
measure: To compare occurrence frequency of CPAP-related adverse effect(s) between the two management modalities
timeFrame: Over the 3 months (tele)visit follow-up
measure: To compare follow-up impact in addition to the annual visit between the two management modalities
timeFrame: Over the 12 months (tele)visit follow-up
measure: To evaluate failed visits number between the two care modalities
timeFrame: Over the 12 months (tele)visit follow-up
measure: To evaluate patient satisfaction with tele-visits
timeFrame: Immediately after the (tele-)visit follow-up
measure: To evaluate technician satisfaction with tele-visits
timeFrame: Immediately after the (tele-)visit follow-up
Other outcomes:
measure: To evaluate patient overall satisfaction regarding clinical study participation
timeFrame: Over the 3 months (tele)visit follow-up
Locations:
city: Meylan
country: France
facility: AGIR à dom.
Study officials:
affiliation: AGIR à Dom
name: Jean Christian BOREL, PhD
role: PRINCIPAL_INVESTIGATOR
References: