Obstructive Sleep Apnea
Conditions
Keywords
tele-visit
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.
Interventions
PROCEDUREtele-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.
Sponsors
AGIR à Dom
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Prospective, interventional, randomized controlled, open-label, single-center, multi-site
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To compare CPAP compliance between the two management modalities | Over the 3 months (tele)visit follow-up | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To compare overall patient satisfaction between the two management modalities | Immediately after the (tele-)visit follow-up | 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. |
| To compare the impact on daytime sleepiness between the two management modalities | At 3 months after (tele-)visit follow-up | 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 |
| To compare impact on quality of life between the two management modalities | At 3 months after (tele-)visit follow-up | 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. |
| To compare CPAP compliance in medium term between the two management modalities | Over the 12 months (tele)visit follow-up | CPAP mean compliance between intervention and control group : in hours/day, collected on the CPAP remote monitoring report |
| To compare impact on CPAP continuation between the two management modalities | Over the 12 months (tele)visit follow-up | Rate of CPAP removal between intervention and control group ; the number of CPAP unbundling among participants |
| To compare treatment effectiveness between the two management modalities | Over the 12 months (tele)visit follow-up | 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. |
| To compare treatment quality on mask leakage between the two management modalities | Over the 3 months (tele)visit follow-up | Leakage mean level between intervention and control group |
| To compare occurrence frequency of CPAP-related adverse effect(s) between the two management modalities | Over the 3 months (tele)visit follow-up | 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. |
| To compare follow-up impact in addition to the annual visit between the two management modalities | Over the 12 months (tele)visit follow-up | Mean number of calls and visits made per patient between control and intervention group |
| To evaluate failed visits number between the two care modalities | Over the 12 months (tele)visit follow-up | Mean number of (tele-)visits requiring a reprogramming (absence, technical problem, last minute deprogramming, home visit...) |
| To evaluate patient satisfaction with tele-visits | Immediately after the (tele-)visit follow-up | 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. |
| To evaluate technician satisfaction with tele-visits | Immediately after the (tele-)visit follow-up | 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. |
| Comparison of the environmental impact associated with the two patient follow-up methods (home visit versus tele-visit) | Over the 12 months (tele)visit follow-up | Comparison of the carbon emissions generated by each care modality, calculated over the entire patient participation period and expressed in kgCO₂e, considering only the impact of the follow-up method itself, without including the individual use of the CPAP device. |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORJean Christian BOREL, PhD
AGIR à Dom
Outcome results
None listed