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

N/AActive Not RecruitingNCT05653804

AGIR à Dom320 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

320

Conditions

Obstructive Sleep Apnea

Interventions

tele-visitPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

AGIR à dom.

Meylan, France

Outcomes

Primary Outcomes

To compare CPAP compliance between the two management modalities

CPAP mean compliance between intervention and control groups, adjusted for the three months prior to inclusion : in hours/day, collected on the CPAP remote monitoring report

Time frame: Over the 3 months (tele)visit follow-up

Secondary Outcomes

To compare overall patient satisfaction between the two management modalities

The Consumer Satisfaction Questionnaire (CSQ-8) mean score between intervention and control groups, after the CPAP (tele-)visit follow-up . The overall score is calculated by adding the respondent's evaluation score (item evaluation) for each item on the scale. For the CSQ-8 version, the scores therefore range from 8 to 32, with higher values indicating greater satisfaction.

Time frame: Immediately after the (tele-)visit follow-up

To compare the impact on daytime sleepiness between the two management modalities

Epworth Sleepiness Scale (ESS) mean score between intervention and control group. All items are assumed to be integers (0-3). The ESS score is the sum of 8 item scores. 0-10 = normal range of sleepiness in healthy adults 11 to 14 = mild sleepiness 15 to 17 = moderate sleepiness 18 to 24 = severe sleepiness

Time frame: At 3 months after (tele-)visit follow-up

To compare impact on quality of life between the two management modalities

The EuroQol 5 Dimensions - 5 levels (EQ5D-5L) questionnaire mean score between intervention and control group, adjusted on the baseline score. it's composed of two parts : A visual analog scale (20 cm line, graduated from 0 to 100 where patient indicates his or her current state of health, 0 being the worst and 100 the best) the completion of 5 items evaluating mobility, autonomy, daily activities, pain or discomfort and anxiety or depression. 1. indicating no problem 2. indicating slight problems 3. indicating moderate problems 4. indicating severe problems 5. indicating unable to/extreme problems Each state is referred to by a 5-digit code.

Data from ClinicalTrials.gov

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