Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT03951467

Using an Intervention Adapted to the Health Literacy Level to Improve Adherence to Medical Recommendations

Led by Hospices Civils de Lyon · Updated on 2025-07-14

300

Participants Needed

4

Research Sites

130 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Health literacy is the ability to access, understand, evaluate and apply information in order to communicate with health professionals and understand health instructions but also, promote, maintain and improve health throughout life. Health literacy is known as a health determinant. Level of Health Literacy is low or limited within 47% of interrogated people in Europe, resulting in an inability to understand and/or use written texts and digital concepts about one's health. There is a demonstrated link between low HL and low therapeutic adherence, an increase in the number of re-admissions, and more generally poor health or survival that is even more limited. An association between low LS and higher health care costs has also been reported in the USA and Switzerland. WHO highlight the central role of Health Literacyin health inequalities, regardless of the region of the world. The investigator chose to conduct this study in patients hospitalized for an acute cardiovascular event: acute myocardial infarction or acute decompensated heart failure , as these patients have cumulative risk factors for misuse and medication errors. They are hospitalized in emergency, for shorter and shorter periods and are discharged with complex drug treatments. The data show that the return home after acute hospitalization for these conditions is a particularly high-risk period for medication errors and misuse, especially with low level of Health Literacy. The proportion of patients with preventable adverse events in the weeks following their return home ranges from 23% to 30% and nearly 60% are re-hospitalized within 6 months. The hypothesis of the study is that in patients hospitalized for cute myocardial infarctionor acute decompensated heart failurewith low Health Literacy levels, information on discharge treatment using appropriate tools and techniques will reduce the risk of patient-related medication errors or misuse within 30 days of discharge. The purpose of this study is to develop an educational intervention model adapted to low Health Literacy levels and routinely feasible, even in case of short stays, in complementarity with traditional therapeutic education programmes that require higher investments and are therefore not accessible to all patients. This innovative approach could then be applied to a large number of chronic diseases.

CONDITIONS

Official Title

Using an Intervention Adapted to the Health Literacy Level to Improve Adherence to Medical Recommendations

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Hospitalized for at least a second acute cardiovascular attack (systolic or diastolic)
  • Living at home before hospitalization for decompensated heart failure or myocardial infarction
  • Affiliated with a health insurance plan
Not Eligible

You will not qualify if you...

  • Short-term life expectancy
  • Bipolar disorders or active psychoses
  • Severe dementia
  • Psychiatric or cognitive conditions that prevent participation
  • Pregnant, parturient, or breastfeeding women
  • People deprived of liberty by judicial or administrative decision
  • Admission to health or social institution for non-research reasons
  • Adults under legal protection measures (guardianship, curatorship)
  • Participation in another ongoing interventional research with an exclusion period
  • Score on S-TOFHLA greater than 22
  • Withdrawal of consent

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 4 locations

1

Hôpital Louis Pradel

Bron, France, 69500

Actively Recruiting

2

Public Health Department

Lyon, France

Actively Recruiting

3

Hôpital Lyon Sud

Pierre-Bénite, France, 69495

Actively Recruiting

4

SSR Val Rosay

Saint-Didier-au-Mont-d'Or, France, 69370

Actively Recruiting

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Research Team

J

Julie HAESEBAERT, MD

CONTACT

E

Estelle BRAVANT

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

2

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Using an Intervention Adapted to the Health Literacy Level to Improve Adherence to Medical Recommendations | DecenTrialz