Back to resultsEvaluate the Benefit of an Individualised Treatment Plan (VitalCare) VS SOC in OSA Patients Treated With CPAP/APAP (VitalCare)
Primary Purpose
Obstructive Sleep Apnoea Syndrome (OSAS)
Status
Recruiting
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
individualised treatment plan (VitalCare) and associated remote medical monitoring
Sponsored by
About this trial
This is an interventional health services research trial for Obstructive Sleep Apnoea Syndrome (OSAS) focused on measuring CPAP/APAP, VitalCare, homecare provider, individualised treatment plan
Eligibility Criteria
Inclusion Criteria:
- Patient diagnosed with Obstructive Sleep Apnoea Syndrome (OSAS) who is newly prescribed CPAP or APAP therapy at inclusion
- Patient agreeing to the collection of data from their CPAP/APAP device via teletransmission
- Patient equipped with a device compatible with the ResMed telemonitoring data platform
- Patient who has signed the informed consent form for the study
Exclusion Criteria:
- Obese patient presenting hypoventilation
- Patient at risk of other sleep disorders (e.g. severe insomnia)
- Patient with physical, mental or cognitive inability to use all components of the remote medical monitoring project and individualised treatment plan, as determined by the investigator wishing to include the patient
- Patient with severe COPD (FEV1 ≤ 50% predicted or modified Medical Research Council (mMRC) dyspnoea scale > 2)
- Patient with severe Chronic Heart Failure (NYHA stage III or IV)
- Patient's refusal of CPAP/APAP treatment support
- Previous CPAP/APAP treatment for Sleep Apnoea
- Patient with ongoing Mandibular Advancement Device (MAD) or in the 12 previous months
- Patient with no permanent place of residence
- Patient participating in another drug or device study within the previous 30 days
Sites / Locations
- Hospital Distrital de SantarémRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Standard of care group
VitalCare group
Arm Description
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,
with patients starting their CPAP/APAP treatment and with a personalized follow-up by the homecare provider.
Outcomes
Primary Outcome Measures
CPAP/APAP adherence evaluation
average daily number of hours of CPAP/APAP use at 3 months
Secondary Outcome Measures
adherence to CPAP/APAP
daily average duration of CPAP/APAP use
evolution of daily Apnoea-Hypopnoea Index (AHI) and Non intentional leaks level teletransmitted by CPAP/APAP devices
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
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
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.
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.
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
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
adverse events description
all adverse events recorded by investigators in the eCRF
Full Information
NCT ID
NCT05246449
First Posted
January 27, 2022
Last Updated
March 3, 2022
Sponsor
Air Liquide Santé International
Collaborators
Clinact
1. Study Identification
Unique Protocol Identification Number
NCT05246449
Brief Title
Evaluate the Benefit of an Individualised Treatment Plan (VitalCare) VS SOC in OSA Patients Treated With CPAP/APAP
Acronym
VitalCare
Official Title
Multi-centre, National, Randomised, Exploratory Study Evaluating the Benefit of an Individualised Treatment Plan(VitalCare) Compared to Standard of Care, in Obstructive Sleep Apnoea Patients Treated With CPAP/APAP
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 15, 2022 (Actual)
Primary Completion Date
May 2022 (Anticipated)
Study Completion Date
May 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Air Liquide Santé International
Collaborators
Clinact
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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 .
Detailed Description
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:
Standard of care group
VitalCare group
Two medical visits in the hospital centres will be scheduled in the context of the study for all participating patients:
A screening/inclusion visit before CPAP/APAP initiation at home;
An end-of-study visit planned at 12 months (± 1 month) after CPAP/APAP initiation at home. All visits done in the hospital centres at the discretion of the investigators between patient's screening/inclusion visit and end-of-study visit will be recorded in the eCRF with the reason for the visit and change in CPAP/APAP prescription, if applicable
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnoea Syndrome (OSAS)
Keywords
CPAP/APAP, VitalCare, homecare provider, individualised treatment plan
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
125 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard of care group
Arm Type
No Intervention
Arm Description
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,
Arm Title
VitalCare group
Arm Type
Experimental
Arm Description
with patients starting their CPAP/APAP treatment and with a personalized follow-up by the homecare provider.
Intervention Type
Other
Intervention Name(s)
individualised treatment plan (VitalCare) and associated remote medical monitoring
Intervention Description
VitalCare is a treatment plan to help in the personalisation of patient care.
Primary Outcome Measure Information:
Title
CPAP/APAP adherence evaluation
Description
average daily number of hours of CPAP/APAP use at 3 months
Time Frame
3rd month
Secondary Outcome Measure Information:
Title
adherence to CPAP/APAP
Description
daily average duration of CPAP/APAP use
Time Frame
1st, 6th,12th months
Title
evolution of daily Apnoea-Hypopnoea Index (AHI) and Non intentional leaks level teletransmitted by CPAP/APAP devices
Description
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
Time Frame
1st, 3rd, 6th,12th months
Title
daytime sleepiness
Description
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
Time Frame
1st, 3rd, 6th,12th months
Title
Snoring and Quality of Life
Description
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.
Time Frame
1st, 3rd, 6th,12th months
Title
For patients in the VitalCare group, Balachandran CPAP perception questionnaire
Description
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.
Time Frame
1st, 3rd, 6th,12th months
Title
Number of contacts between home healthcare provider and patient
Description
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
Time Frame
1st, 3rd, 6th,12th months
Title
For patients in the VitalCare group, number of updates of the individualised treatment plan
Description
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
Time Frame
1st, 3rd, 6th,12th months
Title
adverse events description
Description
all adverse events recorded by investigators in the eCRF
Time Frame
through study completion, an average of 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient diagnosed with Obstructive Sleep Apnoea Syndrome (OSAS) who is newly prescribed CPAP or APAP therapy at inclusion
Patient agreeing to the collection of data from their CPAP/APAP device via teletransmission
Patient equipped with a device compatible with the ResMed telemonitoring data platform
Patient who has signed the informed consent form for the study
Exclusion Criteria:
Obese patient presenting hypoventilation
Patient at risk of other sleep disorders (e.g. severe insomnia)
Patient with physical, mental or cognitive inability to use all components of the remote medical monitoring project and individualised treatment plan, as determined by the investigator wishing to include the patient
Patient with severe COPD (FEV1 ≤ 50% predicted or modified Medical Research Council (mMRC) dyspnoea scale > 2)
Patient with severe Chronic Heart Failure (NYHA stage III or IV)
Patient's refusal of CPAP/APAP treatment support
Previous CPAP/APAP treatment for Sleep Apnoea
Patient with ongoing Mandibular Advancement Device (MAD) or in the 12 previous months
Patient with no permanent place of residence
Patient participating in another drug or device study within the previous 30 days
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Juan-Fernando Ramirez
Phone
+33 (0)1 39 07 63 42
Email
fralsi-ctpublication@airliquide.com
Facility Information:
Facility Name
Hospital Distrital de Santarém
City
Santarém
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gustavo REIS, Dr
Phone
938878010
Email
coimbrareis@hotmail.com
12. IPD Sharing Statement
Learn more about this trial
Evaluate the Benefit of an Individualised Treatment Plan (VitalCare) VS SOC in OSA Patients Treated With CPAP/APAP
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