NCT03004716|Completed
Telemonitoring in Pulmonary Rehabilitation: Validity of a Remote Pulse Oxymetry System
TELE-REHAB
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TELE-REHAB
Sponsor study identifier
observational
5
1 country
1
Study Start
January 2017
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2017
Actual (reported)Study Completion
March 2017
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2017
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 21, 2016
Actual (reported)December 29, 2016
Actual (reported)January 2017
Date type not reportedThis date has not been verified as actual or estimated.
March 2017
Actual (reported)March 2017
Actual (reported)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.
5 sessions of 45min of aerobic training will be carried out on 5 separate days (with a minimum of 1 day of rest between sessions) for a total time frame of 2 months. Data will be collected at the end of every session. Final endpoint will be the reliability of the data through study completion (5 sessions of 45min).
HR is assessed during a session of 45min for a total time frame 1h maximum.
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.
5 sessions of 45min of aerobic training will be carried out on 5 separate days (with a minimum of 1 day of rest between sessions) for a total time frame of 2 months. Data will be collected at the end of every session. Final endpoint will be the reliability of the data through study completion (5 sessions of 45min).
HR is assessed during a session of 45min for a total time frame 1h maximum.
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.
5 sessions of 45min of aerobic training will be carried out on 5 separate days (with a minimum of 1 day of rest between sessions) for a total time frame of 2 months. Data will be collected at the end of every session. Final endpoint will be the reliability of the data through study completion (5 sessions of 45min).
HR is assessed during a session of 45min for a total time frame 1h maximum.
Reliability between the transcutaneous saturation (SpO2) acquired directly with the oximeter (Nonin 3150) and SpO2 provided by the telemedicine gateway.
HR is assessed during 5 training sessions of 45min for a total time frame of 2month.
Reliability of the telemedicine gateway in providing data.
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).
Patient's satisfaction assessed by Likert scale.
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.
Ability of the patients to be autonomous when using the device.
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.
5 consecutive patients with chronicle obstructive pulmonary disease are offered to participate in the protocol when they have reached 45 min of aerobic training during their pulmonary rehabilitation program. During 5 sessions of 45 min, they are monitored with an oximeter device (Nonin 3150) which records heart rate (HR) and oxygen transcutaneous saturation (SpO2). The device also communicates with a telemedicine medical gateway which sends these data to a remote telemedicine center. Data are then provided on a secured online platform and compared with data recorded on the device (Nonin 3150).
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Patients with chronicle obstructive pulmonary disease reffered for pulmonary rehabilitation.
ADIR Association
Bois-Guillaume, France
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.
5 participants (actual enrollment reported by the registry).
First Submitted
December 21, 2016
First Posted
December 29, 2016
Study Start
January 2017
Date type not reportedThis date has not been verified as actual or estimated.
Factors Associated With Acceptance of Home-Based Pulmonary Telerehabilitation in COPD
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.
5 sessions of 45min of aerobic training will be carried out on 5 separate days (with a minimum of 1 day of rest between sessions) for a total time frame of 2 months. Data will be collected at the end of every session. Final endpoint will be the reliability of the data through study completion (5 sessions of 45min).
HR is assessed during a session of 45min for a total time frame 1h maximum.
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.
5 sessions of 45min of aerobic training will be carried out on 5 separate days (with a minimum of 1 day of rest between sessions) for a total time frame of 2 months. Data will be collected at the end of every session. Final endpoint will be the reliability of the data through study completion (5 sessions of 45min).
HR is assessed during a session of 45min for a total time frame 1h maximum.
Contact the study team to confirm eligibility.
Primary Completion
March 2017
Actual (reported)Study Completion
March 2017
Actual (reported)Last Updated
March 14, 2017
Record last verified: 2017-03
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Source: ClinicalTrials.gov.
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