NCT03395418

Brief Summary

Asthma and COPD have a significant impact on public health, affecting about 8 million people in France and generating health care costs of 5.5 billion euros, almost 50% of which are dedicated to long-term treatments are essentially inhaled therapies. The good control of the disease depends on the patient's compliance, but also on the proper use of the devices used for the administration of inhaled drugs under penalty of the degradation of the control of the disease with major medical and medico-economic consequences. Thus, education of these patients in the use of devices must be an integral part of medical care. It comes up against the complexity of the therapeutic arsenal on the one hand and on the other hand with its time-consuming nature: this makes it incompatible with a realization in consultation. The "ARGOS" process is a telemonitoring project for the support of therapeutic education, consisting in setting up a concrete and real-time relay between prescribers and patients for the education of inhaled therapeutics. Its objective is to provide the answer to what is currently an "unmet need" in the management of asthma and COPD, with the prospect of a positive impact on the observance of these treatments and by consequently their clinical and economic efficiency.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2017

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

Study Start

First participant enrolled

December 1, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 4, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 10, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

March 29, 2023

Status Verified

March 1, 2023

Enrollment Period

1.8 years

First QC Date

January 4, 2018

Last Update Submit

March 28, 2023

Conditions

Keywords

COPDAsthmaInhaled Therapeutics

Outcome Measures

Primary Outcomes (1)

  • Percentage of exploitable films

    Ratio between the number of exploitable films and the number of films arriving at the telemedicine platform.

    Day 1 to day 7

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients followed in pneumology for asthma or COPD who have: * a prescription for long-term inhaled therapeutics * also a home health provider (either for long-term oxygen or for a CPAP, NIV ...)

You may qualify if:

  • Patient followed in Pneumology for asthma or COPD with a prescription for long-term inhaled therapies AND a home health provider (who monitors either home oxygen and / or respiratory equipment)
  • The patient must have a means of telephone communication in order to be able to be contacted by a provider, an H2AD permanence or a doctor
  • Patient having given his agreement after having been informed in writing of the purpose and the data collected during this study
  • Age ≥ 18 years
  • Beneficiary of a social security scheme

You may not qualify if:

  • Refusal of the patient
  • Patient not understanding French
  • Absence of home health provider
  • Absence of means of telephone communication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ANTADIR

Paris, 75006, France

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveAsthma

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBronchial DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2018

First Posted

January 10, 2018

Study Start

December 1, 2017

Primary Completion

September 1, 2019

Study Completion

November 1, 2019

Last Updated

March 29, 2023

Record last verified: 2023-03

Locations