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CompletedNCT03295474Updated Feb 26, 2019

Telemonitoring in Pulmonary Rehabilitation: Feasibility and Acceptability of a Remote Pulse Oxymetry System.

An observational study in Chronic Obstructive Pulmonary Disease, Pulmonary Rehabilitation and Telemedicine, sponsored by ADIR Association. Completed at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-02-26.

Sponsored by ADIR Association · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
01

Study summary

Pulmonary rehabilitation effectively improves outcomes in patients with chronic respiratory disease, however there is a lack of pulmonary rehabilitation centers. Telehealth technology is one solution to deliver supervised home-based rehabilitation (tele-rehabilitation).

However, the feasibility and the acceptability of using telehealth technology to deliver tele-rehabilitation has not been assessed in a large scale multicenter study.

Therefore, the aim of this study is to assess the feasibility and the acceptability of telemonitoring system during pulmonary rehabilitation in patients with chronic respiratory disease.

02

Conditions studied

  • Chronic Obstructive Pulmonary Disease
  • Pulmonary Rehabilitation
  • Telemedicine
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Every patients referred for pulmonary rehabilitation.

Inclusion criteria

  • Age > 18 years ;
  • Referred for pulmonary rehabilitation (every chronic respiratory disease accepted).

Exclusion criteria

Exclusion Criteria:

  • Pregnant woman or likely to be ;
  • Patient under guardianship ;
  • Neuropathic disorder ;
  • Contraindication to cardiopulmonary exercise testing or pulmonary rehabilitation.
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (actual)
Patient registry
No

Groups and cohorts

  • Rehabilitation using telehealth technology

    Other: Rehabilitation using telehealth technology

Interventions

  • OtherRehabilitation using telehealth technology

    Consecutive patients with chronic respiratory disease referred for pulmonary rehabilitation are offered to participate in the protocol. Patients are taught to use the system during the first session of aerobic training. During 2 to 5 sessions of aerobic training (depending on the number of sessions needed to be autonomous), they are monitored in the pulmonary rehabilitation center with an oximeter device (Nonin 3150). At the end of every session, patients are asked to answer to 3 questions on a Likert scale (see outcome session). The therapist also ascertains wether the telemonitoring gateway successfully provided informations regarding the session. The study takes off on the session during which the patients are autonomous in using the telehealthcare system. If patients are not autonomous on the fifth session, the study also takes off.

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 2 to 5 sessions for 100 different patients will be assessed for a total time frame a 1 year. Data will be collected after every sessions and presented as the number of patients autonomous when using the device

  2. Patient's satisfaction assessed by Likert scale.

    Data will be presented as the patient's satisfaction of the system at the end of the 5 sessions

    Time frame: 2 to 5 sessions for 100 different patients will be assessed for a total time frame a 1 year. Outcome will be assessed during the sessions of every patient

  3. 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. Calculation : number of sessions provided by telemedicine gateway/number of scheduled sessions

    Time frame: 2 to 5 sessions will be carried out for 100 patients for a total time frame of 1 year. For every patient, sessions will be carried out on separate days (with a minimum of 1 day of rest between sessions)

06

Study locations

2 sites
  • ADIR Association
    Bois-Guillaume, 76230, France
  • Groupe Hospitalier du Havre
    Le Havre, 76600, France
07

References and documents

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. PubMed 30573441 ↗
08

Registry details

Key details

Study ID
NCT03295474
Lead sponsor
ADIR Association
Responsible party
Sponsor
First posted
Sep 27, 2017
Start date
Sep 28, 2017
Primary completion
Oct 30, 2018
Completion
Nov 30, 2018
Last update
Feb 26, 2019

Study contacts

Catherine Tardif, MD
principal investigator · CHU-Hôpitaux de Rouen - Hôpital de Bois-Guillaume, Service de physiologie urinaire, digestive, respiratoire et sportive, Bois-Guillaume, France
Cuvelier Antoine, Prof, PhD
study chair · CHU-Hôpitaux de Rouen - Service de pneumologie, Hôpital de Bois-Guillaume, Rouen, France ; UPRES EA 3830, Institut de Recherche et d'Innovation Biomédicale de Haute-Normandie, Université de Rouen, Rouen, France.
Tristan Bonnevie, MsC
study chair · ADIR Association, Bois-Guillaume, France ; UPRES EA 3830, Institut de Recherche et d'Innovation Biomédicale de Haute-Normandie, Université de Rouen, Rouen, France
Francis-Edouard Gravier, PT
study chair · ADIR Association, Bois-Guillaume, France
Catherine Viacroze, MD
study chair · CHU-Hôpitaux de Rouen - Hôpital de Bois-Guillaume, Service de pneumologie, Bois-Guillaume, France
David Debeaumont, MD
study chair · CHU-Hôpitaux de Rouen - Hôpital de Bois-Guillaume, Service de physiologie urinaire, digestive, respiratoire et sportive, Bois-Guillaume, France
Jean-François Muir, Prof, PhD
study chair · CHU-Hôpitaux de Rouen - Service de pneumologie, Hôpital de Bois-Guillaume, Rouen, France ; UPRES EA 3830, Institut de Recherche et d'Innovation Biomédicale de Haute-Normandie, Université de Rouen, Rouen, France ; ADIR Association, Bois-Guillaume, France
Bouchra Lamia, Prof, PhD
study chair · UPRES EA 3830, Institut de Recherche et d'Innovation Biomédicale de Haute-Normandie, Université de Rouen, Rouen, France ; Service de pneumologie, Hôpital Jacques Monod 76290 Montivilliers
Jean Quieffin, MD
study chair · Service de pneumologie, Hôpital Jacques Monod 76290 Montivilliers
Guillaume Prieur, MsC
study chair · Service de pneumologie, Hôpital Jacques Monod 76290 Montivilliers.
Clément Médrinal, MsC
study chair · UPRES EA 3830, Institut de Recherche et d'Innovation Biomédicale de Haute-Normandie, Université de Rouen, Rouen, France. Service de réanimation, Groupe Hospitalier du Havre, France

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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