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Completed

NCT Number: NCT03971630

Tele-monitoring of Patients With Home Mechanical Ventilation (HMV) Trough Telemedicine System (MyVENT)

The purpose of this study is to improve HMV treatment adherence using an integrated telemedicine platform (MyVENT system)

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario Arnau de Vilanova

Lleida, 25198, Spain

About this study

The investigators propose a study to evaluate the effect of using tele-monitoring in the follow-up of patients with HMV in order to improve their compliance and evaluate its cost-effectiveness. Telemedicine will be provided by an integrated platform composed by a website and a smartphone application for achieve a real feedback between patients and clinicians.

Design: Prospective randomized clinical study that will include 184 patients with HMV. The study will be divided in two phases, the first one consisting on the website and App system development and the second one consisting on a clinical trial where the two follow-up systems (standard care vs MyVENT group) will be compared.

Randomization: Patients will be randomised into two groups, HMV treatment management with standard care vs. telemedicine follow up.

Intervention:

Group 1:MyVENT group: patients will be followed up by tele-monitoring support. MyVENT System will be updated with data extracted from the ventilation equipment. This information and the results of the complementary tests will be sent to the clinician.

Moreover, with MyVENT APP patients will receive information about their treatment and advices to improve therapy if needed.

Group 2: Standard care. In this group all the visits will be performed at hospital following daily clinical practice.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Men and women over to 18 years old.
  • Signed informed consent.
  • Good knowledge about the use of smartphones.
  • Patients with Chronic Obstructive Pulmonary Disease (COPD), obesity-hypoventilation syndrome and chest wall disorders who had started HMV at least three months before their inclusion.

Exclusion criteria

  • Chronic pathology limiting life expectancy less than 1 year.
  • Psychiatric limiting problems.
  • Pregnancy

Treatment and study plan

Telemedicine

Other

Patients will be followed up using the MyVENT System and APP

Primary outcomes

  1. Adherence to HMV treatment.

    Time frame: 9 months

    The number of treatment hours will be obtained by the system counter

Secondary outcomes

  1. Treatment efficiency

    Time frame: 9 months

    Reduce or maintain carbon dioxide (CO2) in the measures

  2. Cost effectiveness

    Time frame: 9 months

    In both arms the evaluation of the cost effectiveness will be made at the end of the study in each group including: (telemedicine cost, HMV carrying charge, number of visits and calls).

  3. Early detection of problems

    Time frame: 9 months

    In MyVENT group the system will send notices to the clinician if it detects any problem in order to solve problems earlier.

  4. Define the patient satisfaction

    Time frame: 9 months

    The study will evaluate the experience of the patient in both follow-up models they will be asked about their satisfaction grade with the follow up care provided during the study using a questionnaire.

Sponsors and collaborators

Lead sponsor

Sociedad Española de Neumología y Cirugía Torácica

Other

Collaborators

  • Fundació Eurecat

Registry information

Official study title

Tele-monitoring of Patients With Home Mechanical Ventilation. "MyVENT" Study.

Acronym: MyVENT

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 3, 2019
Registry last updated
Nov 22, 2023

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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