Telemonitoring in Pulmonary Rehabilitation: Validity of a Remote Pulse Oxymetry System

Chronic Obstructive Pulmonary Disease Clinical Trial

— TELE-REHAB  

Official title:

Telemonitoring in Pulmonary Rehabilitation: Validity of a Remote Pulse Oxymetry System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03004716
• Other study ID #: TELE-REHAB
• Status: Completed
• Phase: N/A
• First received: December 21, 2016
• Last updated: March 13, 2017
• Start date: January 2017
• Est. completion date: March 2017

Study information

• Verified date: March 2017
• Source: ADIR Association
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Pulmonary Rehabilitation
• Telemedicine

Intervention

Other:
• Aerobic training
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).

Locations

Country	Name	City	State
France	ADIR Association	Bois-Guillaume

Sponsors (1)

Lead Sponsor	Collaborator
ADIR Association

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Secondary	Reliability between the transcutaneous saturation (SpO2) acquired directly with the oximeter (Nonin 3150) and SpO2 provided by the telemedicine gateway.	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 5 training sessions of 45min for a total time frame of 2month.
Secondary	Reliability of the telemedicine gateway in providing data.	Data will be collected at the end of every sessions. Final endpoint will be the reliability of the telemedicine Gateway in providing data through study completion (5sessions of 45min for 5 different patients).; Calculation : number of sessions provided by telemedicine gateway/number of scheduled sessions (n=25)	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).
Secondary	Patient's satisfaction assessed by Likert scale.	Data will be presented as the patient's satisfaction of the system on the last of the 5 sessions at the end of the study.	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.
Secondary	Ability of the patients to be autonomous when using the device.	Number of patients autonomous when using the device will be presented for the the 2nd, 3rd, 4th and 5th session.	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.