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

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

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

Study Overview

• Status: Completed
• Conditions: Ventilatory Failure
• Intervention / Treatment: Other: Telemedicine

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ferran Barbe Illa, MD; Phone Number: +34 (973) 70 53 72; Email: fbarbe.lleida.ics@gencat.cat
• Study Contact Backup: Name: Ferran Barbé Illa; Phone Number: +34 (973) 70 53 72; Email: fbarbe.lleida.ics@gencat.cat

Study Locations

• Spain
  • Lleida, Spain, 25198
    • Hospital Universitario Arnau de Vilanova

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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.
Experimental: MyVENT group; These patients will be followed up using the telemedicine (MyVENT System and APP)	Other: Telemedicine; Patients will be followed up using the MyVENT System and APP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence to HMV treatment.	The number of treatment hours will be obtained by the system counter	9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment efficiency	Reduce or maintain carbon dioxide (CO2) in the measures	9 months
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
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
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

Collaborators and Investigators

• Sponsor: Sociedad Española de Neumología y Cirugía Torácica
• Collaborators: Fundació Eurecat
• Investigators: Principal Investigator: Ferran Barbé Illa, Spanish Respiratory Society

Study record dates

Study Major Dates

• Study Start (Actual): January 21, 2021
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): June 30, 2022

Study Registration Dates

• First Submitted: May 27, 2019
• First Submitted That Met QC Criteria: May 31, 2019
• First Posted (Actual): June 3, 2019

Study Record Updates

• Last Update Posted (Estimated): November 22, 2023
• Last Update Submitted That Met QC Criteria: November 21, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Telemedicine; Tele-monitoring; HMV; Chronic hypercapnic respiratory failure
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Respiratory Insufficiency; Hypoventilation
• Other Study ID Numbers: MyVENT1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No