Clinical trial NCT03004716: Telemonitoring in Pulmonary Rehabilitation: Validity of a Remote Pulse Oxymetry System
Official title: Telemonitoring in Pulmonary Rehabilitation: Validity of a Remote Pulse Oxymetry System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease
Pulmonary Rehabilitation
Telemedicine
Lead sponsor: ADIR Association
Sponsor class: OTHER
First posted: 2016-12-29
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with chronicle obstructive pulmonary disease reffered for pulmonary rehabilitation.

Brief summary: The purpose of this study is to assess the feasibility and the reliability of a telemonitoring system during pulmonary rehabilitation in patients with chronicle obstructive pulmonary disease.

The feasibility is assessed using the patient's satisfaction and it ease of use.

The reliability of the remote telemonitoring system is assessed comparing the local data (extracted from the monitoring device itself) and the data transmitted through the telemonitoring platform.


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years ;
* Chronicle obstructive pulmonary disease stage II/III/IV (FEV1 \< 80%) ;
* Referred for pulmonary rehabilitation.

Exclusion Criteria:

* Pregnant woman or likely to be ;
* Patient under guardianship ;
* Neuropathic disorder ;
* Contraindication to cardiopulmonary exercise testing or pulmonary rehabilitation ;
* Progressive cancer.

Primary outcomes:
measure: Reliability between the heart rate (HR) acquired directly with the oximeter (Nonin 3150) and HR provided by the telemedicine gateway during the 1st session of 45 of aerobic training.
timeFrame: HR is assessed during a session of 45min for a total time frame 1h maximum.
measure: Reliability between the heart rate (HR) acquired directly with the oximeter (Nonin 3150) and HR provided by the telemedicine gateway during the 2nd session of 45 of aerobic training.
timeFrame: HR is assessed during a session of 45min for a total time frame 1h maximum.
measure: Reliability between the heart rate (HR) acquired directly with the oximeter (Nonin 3150) and HR provided by the telemedicine gateway during the 3rd session of 45 of aerobic training.
timeFrame: HR is assessed during a session of 45min for a total time frame 1h maximum.
measure: Reliability between the heart rate (HR) acquired directly with the oximeter (Nonin 3150) and HR provided by the telemedicine gateway during the 4th session of 45 of aerobic training.
timeFrame: HR is assessed during a session of 45min for a total time frame 1h maximum.
measure: Reliability between the heart rate (HR) acquired directly with the oximeter (Nonin 3150) and HR provided by the telemedicine gateway during the 5th session of 45 of aerobic training.
timeFrame: HR is assessed during a session of 45min for a total time frame 1h maximum.
Secondary outcomes:
measure: Reliability between the transcutaneous saturation (SpO2) acquired directly with the oximeter (Nonin 3150) and SpO2 provided by the telemedicine gateway.
timeFrame: HR is assessed during 5 training sessions of 45min for a total time frame of 2month.
measure: Reliability of the telemedicine gateway in providing data.
timeFrame: 5 sessions of 45min will be carried out for 5 patients for a total time frame of 4months. For every patient, sessions will be carried out on 5 separate days (with a minimum of 1 day of rest between sessions).
measure: Patient's satisfaction assessed by Likert scale.
timeFrame: 5 sessions for 5 different patients will be assessed for a total time frame a 6month. Outcome will be assessed during the final session of every patient.
measure: Ability of the patients to be autonomous when using the device.
timeFrame: 5 sessions for 5 different patients will be assessed for a total time frame a 6month. Data will be collected after every sessions and presented as the number of patients autonomous when using the device.
Other outcomes:
Locations:
city: Bois-Guillaume
country: France
facility: ADIR Association
Study officials:
References:
citation: Bonnevie T, Gravier FE, Elkins M, Dupuis J, Prieur G, Combret Y, Viacroze C, Debeaumont D, Robleda-Quesada A, Quieffin J, Lamia B, Patout M, Cuvelier A, Muir JF, Medrinal C, Tardif C. People undertaking pulmonary rehabilitation are willing and able to provide accurate data via a remote pulse oximetry system: a multicentre observational study. J Physiother. 2019 Jan;65(1):28-36. doi: 10.1016/j.jphys.2018.11.002. Epub 2018 Dec 17.