Telemonitoring in Pulmonary Rehabilitation: Validity of a Remote Pulse Oxymetry System (TELE-REHAB)

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.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease; Telemedicine; Pulmonary Rehabilitation
• Intervention / Treatment: Other: Aerobic training

• Study Type: Observational
• Enrollment (Actual): 5

Contacts and Locations

Study Locations

• France
  • Bois-Guillaume, France
    • ADIR Association

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with chronicle obstructive pulmonary disease reffered for pulmonary rehabilitation.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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).
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.
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.

Collaborators and Investigators

• Sponsor: ADIR Association

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2017
• Primary Completion (Actual): March 1, 2017
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: December 21, 2016
• First Submitted That Met QC Criteria: December 23, 2016
• First Posted (Estimate): December 29, 2016

Study Record Updates

• Last Update Posted (Actual): March 14, 2017
• Last Update Submitted That Met QC Criteria: March 13, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: TELE-REHAB