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

Sociedad Española de Neumología y Cirugía Torácica

Status: Completed

Conditions: Ventilatory Failure

Treatments: Other: Telemedicine

Study type: Interventional

Funder types: Other

Identifiers

NCT03971630

MyVENT1

Details and patient eligibility

About

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

Full description

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.

Enrollment: 42 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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42 participants in 2 patient groups

Standard care group

No Intervention group

Description:

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.

MyVENT group

Experimental group

Description:

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

Treatment:

Other: Telemedicine