NCT05320276

Brief Summary

Chronic diseases are frequent and potentially severe. Type II diabetes, asthma and heart failure affect 3.3 million, 4 million and 1 million people respectively in France. They are sources of avoidable mortality as well as disabilities leading to a loss of years of full health life (DALYS). Cumulatively, they were responsible for the loss of more than 1 million DALYS in 2019 in France. National and international recommendations also include TVE in the management of these three diseases. This severity can be reduced by better management underpinned by therapeutic education. By improving their knowledge of the disease, it allows a better adherence of patients to the care project, the achievement of clinical and biological objectives, a decrease in the number of emergency room visits and unscheduled hospitalizations, and an improvement in the quality of life during the course of three frequent chronic diseases such as type 2 diabetes, asthma and heart failure. However, participation in a therapeutic education program remains highly variable depending on many parameters. Lack of information seems to play a major role in this context. In the Ile de France region, the density of available TEP programs is high, particularly in Paris. The three chronic diseases that are managed by an advanced practice nurse with a PCS mention have the largest number of TVE programs in Paris: type 2 diabetes (32, and 6 for diabetic foot), asthma and heart failure. In an urban area with a good supply of TVE facilities, how can investigators explain the lack of integration of these facilities into the care pathway? Among the diverse patient population consulting an emergency department suffering from type II diabetes, asthma or heart failure, investigators wish to determine the proportion of patients who have not been offered TVE during their care. Investigators will then try to identify demographic, socioeconomic, and medical factors statistically associated with the absence of FTE proposal.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
297

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2022

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

February 28, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 31, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 11, 2022

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 26, 2023

Completed
Last Updated

April 27, 2023

Status Verified

April 1, 2023

Enrollment Period

2 months

First QC Date

March 31, 2022

Last Update Submit

April 26, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Frequency of patients with chronic diseases seen in the emergency department who have not been offered an educational program

    This outcome corresponds to the number of patients who have not been offered participation in a therapeutic education program during their course of care since the diagnosis of their chronic disease.

    Day 1

Secondary Outcomes (2)

  • Patient Characteristics Associated with Not Offering a Therapeutic Education Program During the Course of Care

    Day 1

  • Identification of reasons for refusal to participate

    Day 1

Eligibility Criteria

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

Patients visit the emergency department for any reason between 12/15/2021 and 3/30/2022 and have at least one of the following chronic conditions: type 2 diabetes, asthma or heart failure.

You may qualify if:

  • Patient whose age is ≥ 18 years
  • Patient consulting the GHPSJ emergency department for any reason
  • Patient with a chronic disease among type 2 diabetes and/or asthma and/or heart failure
  • Francophone patient

You may not qualify if:

  • Diagnosis of the chronic disease in the context of its current management in the emergency room
  • Patient being followed outside of Ile de France for the chronic disease studied
  • Patient with dementia or cognitive disorders
  • Patient under guardianship or curatorship
  • Patient deprived of liberty
  • Patient under legal protection
  • Patient opposing the use of his data for this research

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Groupe Hospitalier Paris Saint-Joseph

Paris, 75014, France

Location

Related Publications (3)

  • Odgers-Jewell K, Ball LE, Kelly JT, Isenring EA, Reidlinger DP, Thomas R. Effectiveness of group-based self-management education for individuals with Type 2 diabetes: a systematic review with meta-analyses and meta-regression. Diabet Med. 2017 Aug;34(8):1027-1039. doi: 10.1111/dme.13340. Epub 2017 Mar 20.

    PMID: 28226200BACKGROUND
  • McGhan SL, Cicutto LC, Befus AD. Advances in development and evaluation of asthma education programs. Curr Opin Pulm Med. 2005 Jan;11(1):61-8. doi: 10.1097/01.mcp.0000146783.18716.31.

    PMID: 15591890BACKGROUND
  • Rice H, Say R, Betihavas V. The effect of nurse-led education on hospitalisation, readmission, quality of life and cost in adults with heart failure. A systematic review. Patient Educ Couns. 2018 Mar;101(3):363-374. doi: 10.1016/j.pec.2017.10.002. Epub 2017 Oct 5.

    PMID: 29102442BACKGROUND

Related Links

MeSH Terms

Conditions

EmergenciesDiabetes MellitusAsthmaHeart Failure

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesHeart DiseasesCardiovascular Diseases

Study Officials

  • Camille GERLIER, MD

    Groupe Hopsitalier Paris Saint-Joseph

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2022

First Posted

April 11, 2022

Study Start

February 28, 2022

Primary Completion

April 15, 2022

Study Completion

April 26, 2023

Last Updated

April 27, 2023

Record last verified: 2023-04

Locations