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

Not Applicable

Completed

• Conditions: Ventilatory Failure
• Interventions: Other: Telemedicine

• Registration Number: NCT03971630
• Lead Sponsor: Sociedad Española de Neumología y Cirugía Torácica

Brief Summary

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

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 Timeline

• Study First Submitted: 2019-05-27
• Study First Submitted QC: 2019-05-31
• Study First Posted: 2019-06-03
• Study Start: 2021-01-21
• Primary Completion: 2022-06-30
• Study Completion: 2022-06-30
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-21
• Last Update Posted: 2023-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MyVENT group	Telemedicine	These patients will be followed up using the telemedicine (MyVENT System and APP)

Primary Outcome Measures

Name	Time	Method
Adherence to HMV treatment.	9 months	The number of treatment hours will be obtained by the system counter

Secondary Outcome Measures

Name	Time	Method
Treatment efficiency	9 months	Reduce or maintain carbon dioxide (CO2) in the measures
Early detection of problems	9 months	In MyVENT group the system will send notices to the clinician if it detects any problem in order to solve problems earlier.
Define the patient satisfaction	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.
Cost effectiveness	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).

Trial Locations

Locations (1)

Hospital Universitario Arnau de Vilanova; 🇪🇸 Lleida, Spain