Hospital Universitario Arnau de Vilanova
Lleida, 25198, Spain
NCT Number: NCT03971630
The purpose of this study is to improve HMV treatment adherence using an integrated telemedicine platform (MyVENT system)
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Lleida, 25198, Spain
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients will be followed up using the MyVENT System and APP
Time frame: 9 months
The number of treatment hours will be obtained by the system counter
Time frame: 9 months
Reduce or maintain carbon dioxide (CO2) in the measures
Time frame: 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).
Time frame: 9 months
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
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.
Sociedad Española de Neumología y Cirugía Torácica
Other
Tele-monitoring of Patients With Home Mechanical Ventilation. "MyVENT" Study.
Acronym: MyVENT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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