Clinical trial NCT03971630: Tele-monitoring of Patients With Home Mechanical Ventilation (HMV) Trough Telemedicine System (MyVENT)
Official title: Tele-monitoring of Patients With Home Mechanical Ventilation. "MyVENT" Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ventilatory Failure
Keywords: HMV
Tele-monitoring
Telemedicine
Chronic hypercapnic respiratory failure
Lead sponsor: Sociedad Española de Neumología y Cirugía Torácica
Sponsor class: OTHER
Collaborators: name: Fundació Eurecat
First posted: 2019-06-03
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Adherence to HMV treatment.
timeFrame: 9 months
Secondary outcomes:
measure: Treatment efficiency
timeFrame: 9 months
measure: Cost effectiveness
timeFrame: 9 months
measure: Early detection of problems
timeFrame: 9 months
measure: Define the patient satisfaction
timeFrame: 9 months
Other outcomes:
Locations:
city: Lleida
country: Spain
facility: Hospital Universitario Arnau de Vilanova
Study officials:
affiliation: Spanish Respiratory Society
name: Ferran Barbé Illa
role: PRINCIPAL_INVESTIGATOR
References: