NCT03971630

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 27, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 3, 2019

Completed
1.6 years until next milestone

Study Start

First participant enrolled

January 21, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

November 22, 2023

Status Verified

November 1, 2023

Enrollment Period

1.4 years

First QC Date

May 27, 2019

Last Update Submit

November 21, 2023

Conditions

Ventilatory Failure

Keywords

HMVTele-monitoringTelemedicineChronic hypercapnic respiratory failure

Outcome Measures

Primary Outcomes (1)

  • Adherence to HMV treatment.

    The number of treatment hours will be obtained by the system counter

    9 months

Secondary Outcomes (4)

  • Treatment efficiency

    9 months

  • Cost effectiveness

    9 months

  • Early detection of problems

    9 months

  • Define the patient satisfaction

    9 months

Study Arms (2)

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)

Other: Telemedicine

Interventions

TelemedicineOTHER

Patients will be followed up using the MyVENT System and APP

MyVENT group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women over to 18 years old.
  • Signed informed consent.
  • Good knowledge about the use of smartphones.

You may not qualify if:

  • Chronic pathology limiting life expectancy less than 1 year.
  • Psychiatric limiting problems.
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario Arnau de Vilanova

Lleida, 25198, Spain

Location

MeSH Terms

Conditions

Hypoventilation

Interventions

Telemedicine

Condition Hierarchy (Ancestors)

Respiratory InsufficiencyRespiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Delivery of Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Ferran Barbé Illa

    Spanish Respiratory Society

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

May 27, 2019

First Posted

June 3, 2019

Study Start

January 21, 2021

Primary Completion

June 30, 2022

Study Completion

June 30, 2022

Last Updated

November 22, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)