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OpenTrials
Completed

NCT Number: NCT03295474

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

ADIR Association, Bois-Guillaume, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

ADIR Association

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Sep 27, 2017
Registry last updated
Feb 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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