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

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

Detailed Description
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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.

Official Title
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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

Conditions
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Obstructive Sleep Apnea

Intervention / Treatment
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* Procedure: tele-visit


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, interventional, randomized controlled, open-label, single-center, multi-site
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: tele-visit by HCP<br>Patients receive a annual CPAP remote visit by HCP technician, then home visit the following year | Procedure: tele-visit<br>* 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.<br>|
| No Intervention: home visit by HCP<br>Standard care : patients receive an annual CPAP home visit by HCP technician | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Over the 3 months (tele)visit follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 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. indicating no problem indicating slight problems indicating moderate problems indicating severe problems indicating unable to/extreme problems Each state is referred to by a 5-digit code. | At 3 months after (tele-)visit follow-up | 
| To compare CPAP compliance in medium term between the two management modalities | CPAP mean compliance between intervention and control group : in hours/day, collected on the CPAP remote monitoring report | Over the 12 months (tele)visit follow-up | 
| To compare impact on CPAP continuation between the two management modalities | Rate of CPAP removal between intervention and control group ; the number of CPAP unbundling among participants | Over the 12 months (tele)visit follow-up | 
| To compare treatment effectiveness between the two management modalities | Apnea Hypopnea Index (AHI) mean between intervention and control group. AHI corresponds to the number of apneas and hypopneas per hour of sleep, collected on the CPAP remote monitoring report. | Over the 12 months (tele)visit follow-up | 
| To compare treatment quality on mask leakage between the two management modalities | Leakage mean level between intervention and control group | Over the 3 months (tele)visit follow-up | 
| To compare occurrence frequency of CPAP-related adverse effect(s) between the two management modalities | The Side-Effects to CPAP treatment Inventory (SECI) mean score between the intervention and control group. Each of the 15 items relating to side effects associated with CPAP treatment has three subscales: frequency, breadth of the side effect, and impact on CPAP use. For each subscale, the patient will complete a five-point Likert-type scale, so the possible range for each subscale is 15 to 75. A higher score indicates greater frequency of side effects, greater breadth of side effects, and greater intensity of side effects. | Over the 3 months (tele)visit follow-up | 
| To compare follow-up impact in addition to the annual visit between the two management modalities | Mean number of calls and visits made per patient between control and intervention group | Over the 12 months (tele)visit follow-up | 
| To evaluate failed visits number between the two care modalities | Mean number of (tele-)visits requiring a reprogramming (absence, technical problem, last minute deprogramming, home visit...) | Over the 12 months (tele)visit follow-up | 
| To evaluate patient satisfaction with tele-visits | The Televisit Satisfaction Questionnaire (TSQ) mean score 14 items, rated between 1 and 5 by the patient. The sum of the items corresponds to a score ranging from 14 to 70. | Immediately after the (tele-)visit follow-up | 
| To evaluate technician satisfaction with tele-visits | The Televisit Satisfaction Questionnaire (TSQ) questionnaire mean score 14 items, rated between 1 and 5 by the patient. The sum of the items corresponds to a score ranging from 14 to 70. | Immediately after the (tele-)visit follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tele-visit