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

Primary Purpose

Ventilatory Failure

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Telemedicine
Sponsored by
Sociedad Española de Neumología y Cirugía Torácica
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ventilatory Failure focused on measuring HMV, Tele-monitoring, Telemedicine, Chronic hypercapnic respiratory failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Hospital Universitario Arnau de VilanovaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard care group

MyVENT group

Arm 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.

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

Outcomes

Primary Outcome Measures

Adherence to HMV treatment.
The number of treatment hours will be obtained by the system counter

Secondary Outcome Measures

Treatment efficiency
Reduce or maintain carbon dioxide (CO2) in the measures
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).
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.
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.

Full Information

First Posted
May 27, 2019
Last Updated
May 4, 2022
Sponsor
Sociedad Española de Neumología y Cirugía Torácica
Collaborators
Fundació Eurecat
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1. Study Identification

Unique Protocol Identification Number
NCT03971630
Brief Title
Tele-monitoring of Patients With Home Mechanical Ventilation (HMV) Trough Telemedicine System (MyVENT)
Acronym
MyVENT
Official Title
Tele-monitoring of Patients With Home Mechanical Ventilation. "MyVENT" Study.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 21, 2021 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sociedad Española de Neumología y Cirugía Torácica
Collaborators
Fundació Eurecat

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventilatory Failure
Keywords
HMV, Tele-monitoring, Telemedicine, Chronic hypercapnic respiratory failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
184 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard care group
Arm Type
No Intervention
Arm 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.
Arm Title
MyVENT group
Arm Type
Experimental
Arm Description
These patients will be followed up using the telemedicine (MyVENT System and APP)
Intervention Type
Other
Intervention Name(s)
Telemedicine
Intervention Description
Patients will be followed up using the MyVENT System and APP
Primary Outcome Measure Information:
Title
Adherence to HMV treatment.
Description
The number of treatment hours will be obtained by the system counter
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Treatment efficiency
Description
Reduce or maintain carbon dioxide (CO2) in the measures
Time Frame
9 months
Title
Cost effectiveness
Description
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).
Time Frame
9 months
Title
Early detection of problems
Description
In MyVENT group the system will send notices to the clinician if it detects any problem in order to solve problems earlier.
Time Frame
9 months
Title
Define the patient satisfaction
Description
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.
Time Frame
9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ferran Barbe Illa, MD
Phone
+34 (973) 70 53 72
Email
fbarbe.lleida.ics@gencat.cat
First Name & Middle Initial & Last Name or Official Title & Degree
Ferran Barbé Illa
Phone
+34 (973) 70 53 72
Email
fbarbe.lleida.ics@gencat.cat
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ferran Barbé Illa
Organizational Affiliation
Spanish Respiratory Society
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario Arnau de Vilanova
City
Lleida
ZIP/Postal Code
25198
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ferran Barbe Illa, MD
Email
fbarbe.lleida.ics@gencat.cat

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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