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

NCT03295474 | Completed

• 1 other identifier: FA-TELE-REHAB
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Chronic Obstructive Pulmonary Disease; Pulmonary Rehabilitation; Telemedicine

Outcome Measures

Primary Outcomes (3)

• 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)

Study Arms (1)

Rehabilitation using telehealth technology

Other: Rehabilitation using telehealth technology

Interventions

Rehabilitation using telehealth technology OTHER

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.

Rehabilitation using telehealth technology

Eligibility Criteria

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

Study Population

Every patients referred for pulmonary rehabilitation.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• ADIR Association: lead

Study Sites (2)

ADIR Association

Bois-Guillaume, 76230, France

Location

Groupe Hospitalier du Havre

Le Havre, 76600, 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 Officials

• Catherine Tardif, MD

  CHU-Hôpitaux de Rouen - Hôpital de Bois-Guillaume, Service de physiologie urinaire, digestive, respiratoire et sportive, Bois-Guillaume, France

  PRINCIPAL INVESTIGATOR

• 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.

  STUDY CHAIR

• 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

  STUDY CHAIR

• Francis-Edouard Gravier, PT

  ADIR Association, Bois-Guillaume, France

  STUDY CHAIR

• Catherine Viacroze, MD

  CHU-Hôpitaux de Rouen - Hôpital de Bois-Guillaume, Service de pneumologie, Bois-Guillaume, France

  STUDY CHAIR

• David Debeaumont, MD

  CHU-Hôpitaux de Rouen - Hôpital de Bois-Guillaume, Service de physiologie urinaire, digestive, respiratoire et sportive, Bois-Guillaume, France

  STUDY CHAIR

• 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

  STUDY CHAIR

• 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

  STUDY CHAIR

• Jean Quieffin, MD

  Service de pneumologie, Hôpital Jacques Monod 76290 Montivilliers

  STUDY CHAIR

• Guillaume Prieur, MsC

  Service de pneumologie, Hôpital Jacques Monod 76290 Montivilliers.

  STUDY CHAIR

• 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

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: September 25, 2017
• First Posted: September 27, 2017
• Study Start: September 28, 2017
• Primary Completion: October 30, 2018
• Study Completion: November 30, 2018
• Last Updated: February 26, 2019

Record last verified: 2019-01

Locations

FR (2)