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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

Telemonitoring in Pulmonary Rehabilitation: Feasibility and Acceptability of a Remote Pulse Oxymetry System (FA-TELE-REHAB)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03295474
• Other study ID #: FA-TELE-REHAB
• Status: Completed
• Start date: September 28, 2017
• Est. completion date: November 30, 2018

Study information

• Verified date: January 2019
• Source: ADIR Association
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 30, 2018
• Est. primary completion date: October 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Pulmonary Rehabilitation
• Telemedicine

Intervention

Other:
• Rehabilitation 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.

Locations

Country	Name	City	State
France	ADIR Association	Bois-Guillaume
France	Groupe Hospitalier du Havre	Le Havre

Sponsors (1)

Lead Sponsor	Collaborator
ADIR Association

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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)