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

NCT ID: NCT03971630

Last Updated: 2023-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-21

Study Completion Date

2022-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Ventilatory Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Standard care group

These patients will be followed by standard protocol in the Unit of HMV of the University Hospital of Santa María- University Hospital Arnau de Vilanova.

Group Type NO_INTERVENTION

No interventions assigned to this group

MyVENT group

These patients will be followed up using the telemedicine (MyVENT System and APP)

Group Type EXPERIMENTAL

Telemedicine

Intervention Type OTHER

Patients will be followed up using the MyVENT System and APP

Interventions

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Telemedicine

Patients will be followed up using the MyVENT System and APP

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundació Eurecat

OTHER

Sponsor Role collaborator

Sociedad Española de Neumología y Cirugía Torácica

OTHER

Sponsor Role lead

Responsible Party

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Ferran Barbe

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ferran Barbé Illa

Role: PRINCIPAL_INVESTIGATOR

Spanish Respiratory Society

Locations

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Hospital Universitario Arnau de Vilanova

Lleida, , Spain

Site Status

Countries

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Spain

Other Identifiers

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MyVENT1

Identifier Type: -

Identifier Source: org_study_id