Ventilatory FailureMyVENTNCT03971630
Tele-monitoring of Patients With Home Mechanical Ventilation (HMV) Trough Telemedicine System (MyVENT)
A study testing Telemedicine in people with Ventilatory Failure, run by Sociedad Española de Neumología y Cirugía Torácica at 1 site in Spain.
Trial summary
The purpose of this study is to improve HMV treatment adherence using an integrated telemedicine platform (MyVENT system) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilatory Failure
- What is being tested?
- Telemedicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteSpain
- Study dates
- 21 Jan 2021to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Chronic pathology limiting life expectancy less than 1 year.
- Psychiatric limiting problems.
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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)
Read the 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.
- Conditions
- Ventilatory Failure
- Being tested
- Telemedicine
- Keywords
- HMV, Tele-monitoring, Telemedicine, Chronic hypercapnic respiratory failure
- Medical subject headings
- Hypoventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelemedicineOther
Patients will be followed up using the MyVENT System and APP
| Study group | Role | What they receive |
|---|---|---|
| Standard care group | No intervention | 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. |
| MyVENT group | Experimental | These patients will be followed up using the telemedicine (MyVENT System and APP) Receives: Other: Telemedicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to HMV treatment.
The number of treatment hours will be obtained by the system counter
Measured: 9 months
Secondary outcomes (4)
Treatment efficiency
Reduce or maintain carbon dioxide (CO2) in the measures
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2019
- Study start21 Jan 2021
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilatory FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sociedad Española de Neumología y Cirugía Torácica
- Sponsor type
- University, hospital or other
- Collaborators
- Fundació Eurecat
- Responsible party
- Principal investigator, Ferran Barbe, Sociedad Española de Neumología y Cirugía Torácica
- Investigators
- Ferran Barbé Illa, Principal investigator, Spanish Respiratory Society
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03971630
- Sponsor's protocol ID
- MyVENT1
- Acronym
- MyVENT
- Status last verified
- Nov 2023
- First submitted
- 27 May 2019
- Last updated
- 22 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tele-monitoring of Patients With Home Mechanical Ventilation. "MyVENT" Study.
- ClinicalTrials.gov ID
- NCT03971630
- Acronym / sponsor ID
- MyVENT / MyVENT1
- Conditions
- Ventilatory Failure
- Keywords
- HMV, Tele-monitoring, Telemedicine, Chronic hypercapnic respiratory failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Sociedad Española de Neumología y Cirugía TorácicaUniversity, hospital or other
- Collaborators
- Fundació Eurecat
- Study start
- 21 Jan 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 3 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard care group | No intervention | –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. |
| MyVENT group | Experimental | Other: TelemedicineThese patients will be followed up using the telemedicine (MyVENT System and APP) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Chronic pathology limiting life expectancy less than 1 year.
- Psychiatric limiting problems.
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TelemedicinePatients will be followed up using the MyVENT System and APP | Other | MyVENT group |
Primary outcome
Adherence to HMV treatment.
Time frame: 9 months
The number of treatment hours will be obtained by the system counter
4 secondary outcomes
Treatment efficiency
Time frame: 9 months
Cost effectiveness
Time frame: 9 months
Early detection of problems
Time frame: 9 months
Define the patient satisfaction
Time frame: 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- Individual participant dataSharing planned: No
Related trials for Ventilatory Failure
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Assessing the Acute Effects of Virtual Reality Interventions on Stress
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Oxytocin for Respiratory Compromise and Hypoventilation Induced by Drugs
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ferran Barbé Illa principal investigator
Spanish Respiratory Society
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telemedicine in people with Ventilatory Failure, run by Sociedad Española de Neumología y Cirugía Torácica at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to HMV treatment. (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2023.