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| Name | Class |
|---|---|
| Clinact | OTHER |
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According to a stratification procedure, the objective of a personalised care plan (VitalCare) is to identify points for improvement since the early stage of the patient's pathway of CPAP/APAP treatment and to adjust patient follow-up .
It is a prospective, exploratory, randomised, multi-centre, open, controlled study with a 1:1 ratio of two parallel groups, with obstructive sleep apnoea patients starting CPAP/APAP therapy, and receiving by the homecare provider, either an individualised treatment plan (VitalCare) or national standard of care.
This study will be conducted in 5 hospital centres in Portugal..
During a regular medical consultation, eligible patients who have signed their informed consent will be randomised by their investigator.
Two study groups will be set up:
Two medical visits in the hospital centres will be scheduled in the context of the study for all participating patients:
The primary objective of this study is to evaluate adherence to CPAP/APAP treatment at 3 months in patients with individualised treatment plan (VitalCare) compared to patients with standard of care
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of care group | No Intervention | with patients starting their regular CPAP/APAP treatment without stratification, with medical follow-up, and with standard home CPAP/APAP service provided by home healthcare, | |
| VitalCare group | Experimental | with patients starting their CPAP/APAP treatment and with a personalized follow-up by the homecare provider. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| individualised treatment plan (VitalCare) and associated remote medical monitoring | Other | VitalCare is a treatment plan to help in the personalisation of patient care. |
|
| Measure | Description | Time Frame |
|---|---|---|
| CPAP/APAP adherence evaluation | average daily number of hours of CPAP/APAP use at 3 months | 3rd month |
| Measure | Description | Time Frame |
|---|---|---|
| adherence to CPAP/APAP | daily average duration of CPAP/APAP use | 1st, 6th,12th months |
| evolution of daily Apnoea-Hypopnoea Index (AHI) and Non intentional leaks level teletransmitted by CPAP/APAP devices |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Distrital de Santarém | Santarém | Portugal |
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Daily Apnoea-Hypopnoea Index (AHI) expressed in average daily number per hour and daily non intentional leaks level expressed in L/min as both median and 95th percentile
| 1st, 3rd, 6th,12th months |
| daytime sleepiness | The numerical answers obtained for the 8 common daily life situations of the Epworth Sleepiness Scale (ESS) are added to calculate the ESS score each time it is collected | 1st, 3rd, 6th,12th months |
| Snoring and Quality of Life | The numerical answers obtained for the 5 questions of the snoring questionnaire are added to calculate the snoring score each time the questionnaire is collected. The numerical answer from 0 to 10 obtained on the Quality of Life visual analogue scale is used each time the questionnaire is collected. | 1st, 3rd, 6th,12th months |
| For patients in the VitalCare group, Balachandran CPAP perception questionnaire | The numerical answers obtained for the 4 questions regarding difficulty tolerating CPAP, discomfort with CPAP pressure, likelihood of wearing CPAP, and perceived health benefit are added to calculate the CPAP perception score each time it is collected. | 1st, 3rd, 6th,12th months |
| Number of contacts between home healthcare provider and patient | The data files extracted from the home healthcare provider database will allow to count for each study patient, the number of contacts between the home healthcare provider and the patient either i) at home, ii) remotely or iii) in care centres | 1st, 3rd, 6th,12th months |
| For patients in the VitalCare group, number of updates of the individualised treatment plan | The data files extracted from the home healthcare provider database will allow to count for each patient from the VitalCare group, the number of updates of the individualised treatment plan | 1st, 3rd, 6th,12th months |
| adverse events description | all adverse events recorded by investigators in the eCRF | through study completion, an average of 1 year |
| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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