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Therapeutic Education ProgramESCAPENCT05320276

Predictors of Non-accESs to therapeutiC EducAtion Programs Among Patients With Type 2 Diabetes, and/or Asthma, and/or Chronic Heart Failure in an Emergency Setting

An observational study of Therapeutic Education Program and Emergencies, run by Fondation Hôpital Saint-Joseph at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
How many people
297 participants
Where
1 siteFrance
Study dates
28 Feb 2022to 26 Apr 2023
Phase
Observational
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

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.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

France1 site

  • Groupe Hospitalier Paris Saint-Joseph

    Paris, 75014

Other trials in France

About this study

Official title: Redictors of Non-accESs to therapeutiC EducAtion Programs Among Patients With Type 2 Diabetes, and/or Asthma, and/or Chronic Heart Failure in an Emergency Setting

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.

Read more

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.

Medical subject headings
Emergencies, Diabetes Mellitus, Asthma, Heart Failure

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Day 1

Secondary outcomes (2)

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

    This outcome corresponds to the demographic, social, economic and medical characteristics statistically associated with the absence of a therapeutic education proposal.

    Measured: Day 1

  2. Identification of reasons for refusal to participate

    This outcome corresponds to the reason for declining to participate in an TEP program for patients who have been offered one.

    Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Apr 2022
  2. Study start28 Feb 2022
  3. Primary completion15 Apr 2022
  4. Study completion26 Apr 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
297 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05320276
Sponsor's protocol ID
ESCAPE
Acronym
ESCAPE
Status last verified
Apr 2023
First submitted
31 Mar 2022
Last updated
27 Apr 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 28226200

  • 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.

    PubMed 15591890

  • 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.

    PubMed 29102442

Questions about this trial

What is this clinical trial studying?

An observational study of Therapeutic Education Program and Emergencies, run by Fondation Hôpital Saint-Joseph at 1 site in France.

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 7 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 27 Apr 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 France. 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?

Frequency of patients with chronic diseases seen in the emergency department who have not been offered an educational program (time frame: Day 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05320276, which also lists 3 linked publications.

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 27 Apr 2023.

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