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Clinical Trials/NCT03295474
NCT03295474CompletedNot Applicable

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

ADIR Association2 sites in 1 country100 target enrollmentStarted: September 28, 2017Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
100
Locations
2
Primary Endpoint
Ability of the patients to be autonomous when using the device.

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

Ability of the patients to be autonomous when using the device.

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

Number of patients autonomous when using the device will be presented for the the 2nd, 3rd, 4th and 5th session.

Patient's satisfaction assessed by Likert scale.

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

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

Reliability of the telemedicine gateway in providing data.

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)

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
ADIR Association
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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