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

Ventilatory Failure Clinical Trial

— MyVENT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03971630
• Other study ID #: MyVENT1
• Status: Completed
• Phase: N/A
• Start date: January 21, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: November 2023
• Source: Sociedad Española de Neumología y Cirugía Torácica
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypoventilation
• Ventilatory Failure

Intervention

Other:
• Telemedicine
Patients will be followed up using the MyVENT System and APP

Locations

Country	Name	City	State
Spain	Hospital Universitario Arnau de Vilanova	Lleida

Sponsors (2)

Lead Sponsor	Collaborator
Sociedad Española de Neumología y Cirugía Torácica	Fundació Eurecat

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence to HMV treatment.	The number of treatment hours will be obtained by the system counter	9 months
Secondary	Treatment efficiency	Reduce or maintain carbon dioxide (CO2) in the measures	9 months
Secondary	Cost effectiveness	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).	9 months
Secondary	Early detection of problems	In MyVENT group the system will send notices to the clinician if it detects any problem in order to solve problems earlier.	9 months
Secondary	Define the patient satisfaction	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.	9 months