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

NCT03004716 | Completed

• 1 other identifier: TELE-REHAB
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease; Pulmonary Rehabilitation; Telemedicine

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (4)

• 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.

Interventions

Aerobic training OTHER

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).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with chronicle obstructive pulmonary disease reffered for pulmonary rehabilitation.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• ADIR Association: lead

Study Sites (1)

ADIR Association

Bois-Guillaume, France

Location

Related Publications (1)

• 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.

  PMID: 30573441 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2016
• First Posted: December 29, 2016
• Study Start: January 1, 2017
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: March 14, 2017

Record last verified: 2017-03

Locations

FR (1)