NCT03295474|Completed
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Sponsor study identifier
observational
100
1 country
2
Study Start
September 28, 2017
Actual (reported)Primary Completion
October 30, 2018
Actual (reported)Study Completion
November 30, 2018
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 30, 2018
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.
September 25, 2017
Actual (reported)September 27, 2017
Actual (reported)September 28, 2017
Actual (reported)October 30, 2018
Actual (reported)November 30, 2018
Actual (reported)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.
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
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
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
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
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)
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Every patients referred for pulmonary rehabilitation.
ADIR Association
Bois-Guillaume, 76230, France
Groupe Hospitalier du Havre
Le Havre, 76600, 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.
Catherine Tardif, MD
CHU-Hôpitaux de Rouen - Hôpital de Bois-Guillaume, Service de physiologie urinaire, digestive, respiratoire et sportive, Bois-Guillaume, France
Cuvelier Antoine, Prof, PhD
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
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
100 participants (actual enrollment reported by the registry).
First Submitted
September 25, 2017
First Posted
September 27, 2017
Study Start
September 28, 2017
Actual (reported)6-minute Stepper Test and Pulmonary Rehabilitation in Patients With Chronicle Obstructive Pulmonary Disease
Contact the study team to confirm eligibility.
ADIR Association, Bois-Guillaume, France
Catherine Viacroze, MD
CHU-Hôpitaux de Rouen - Hôpital de Bois-Guillaume, Service de pneumologie, Bois-Guillaume, France
David Debeaumont, MD
CHU-Hôpitaux de Rouen - Hôpital de Bois-Guillaume, Service de physiologie urinaire, digestive, respiratoire et sportive, Bois-Guillaume, France
Jean-François Muir, Prof, PhD
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
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
Service de pneumologie, Hôpital Jacques Monod 76290 Montivilliers
Guillaume Prieur, MsC
Service de pneumologie, Hôpital Jacques Monod 76290 Montivilliers.
Clément Médrinal, MsC
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
Primary Completion
October 30, 2018
Actual (reported)Study Completion
November 30, 2018
Actual (reported)Last Updated
February 26, 2019
Record last verified: 2019-01
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