Clinical trial NCT03295474: Telemonitoring in Pulmonary Rehabilitation: Feasibility and Acceptability of a Remote Pulse Oxymetry System.
Official title: Telemonitoring in Pulmonary Rehabilitation: Feasibility and Acceptability of a Remote Pulse Oxymetry System (FA-TELE-REHAB)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease
Pulmonary Rehabilitation
Telemedicine
Lead sponsor: ADIR Association
Sponsor class: OTHER
First posted: 2017-09-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Every patients referred for pulmonary rehabilitation.

Brief 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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Ability of the patients to be autonomous when using the device.
timeFrame: 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
measure: Patient's satisfaction assessed by Likert scale.
timeFrame: 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
measure: Reliability of the telemedicine gateway in providing data.
timeFrame: 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)
Secondary outcomes:
Other outcomes:
Locations:
city: Bois-Guillaume
country: France
facility: ADIR Association
city: Le Havre
country: France
facility: Groupe Hospitalier du Havre
Study officials:
affiliation: CHU-Hôpitaux de Rouen - Hôpital de Bois-Guillaume, Service de physiologie urinaire, digestive, respiratoire et sportive, Bois-Guillaume, France
name: Catherine Tardif, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: 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.
name: Cuvelier Antoine, Prof, PhD
role: STUDY_CHAIR
affiliation: ADIR Association, Bois-Guillaume, France ; UPRES EA 3830, Institut de Recherche et d'Innovation Biomédicale de Haute-Normandie, Université de Rouen, Rouen, France
name: Tristan Bonnevie, MsC
role: STUDY_CHAIR
affiliation: ADIR Association, Bois-Guillaume, France
name: Francis-Edouard Gravier, PT
role: STUDY_CHAIR
affiliation: CHU-Hôpitaux de Rouen - Hôpital de Bois-Guillaume, Service de pneumologie, Bois-Guillaume, France
name: Catherine Viacroze, MD
role: STUDY_CHAIR
affiliation: CHU-Hôpitaux de Rouen - Hôpital de Bois-Guillaume, Service de physiologie urinaire, digestive, respiratoire et sportive, Bois-Guillaume, France
name: David Debeaumont, MD
role: STUDY_CHAIR
affiliation: 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
name: Jean-François Muir, Prof, PhD
role: STUDY_CHAIR
affiliation: 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
name: Bouchra Lamia, Prof, PhD
role: STUDY_CHAIR
affiliation: Service de pneumologie, Hôpital Jacques Monod 76290 Montivilliers
name: Jean Quieffin, MD
role: STUDY_CHAIR
affiliation: Service de pneumologie, Hôpital Jacques Monod 76290 Montivilliers.
name: Guillaume Prieur, MsC
role: STUDY_CHAIR
affiliation: 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
name: Clément Médrinal, MsC
role: STUDY_CHAIR
References:
citation: 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.