RecruitingNot ApplicableNCT03951467

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

Impact of a Strategy Dedicated to Low Health Literacy Level Patients to Improve Their Understanding and Ownership of the Discharge Prescription in Cardio-vascular Diseases


Sponsor

Hospices Civils de Lyon

Enrollment

300 participants

Start Date

Jun 26, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a health education program specifically designed for people with low health literacy — meaning people who may find it hard to understand medical information — who have been hospitalized for heart failure. The program aims to help patients understand and follow their doctor's recommendations to prevent their heart failure from getting worse again. **You may be eligible if...** - You are at least 18 years old - You have been hospitalized for at least your second episode of heart failure - You were living at home before this hospitalization - You are enrolled in a health insurance plan - You have a low health literacy score (as measured by the S-TOFHLA test) **You may NOT be eligible if...** - You have a short-term life-threatening prognosis - You have severe dementia, active psychosis, or bipolar disorder - You are pregnant or breastfeeding - You are already enrolled in another clinical trial with an exclusion period - You are under legal guardianship or a protected adult Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERInterventional educational toolkit specific to low Health Literacy patients, designed with patients and health professionals.

Three interviews between the patient and a health advisor trained for the study: two times before discharge from hospital and a telephone reminder within 3 weeks after discharge. First and second interview: the nurse will evolve using tools developed in the first phase of the study. The nurse will provide detailed personalized information on the patient's discharge order and illness and the action to be taken depending on the potential situations the patient may encounter. Telephone interview: within 3 weeks after discharge, the nurse will repeat the elements of the first interview with the patient to verify that the information has been properly understood and retained and that the patient is able to adopt appropriate behaviors in high-risk situations. Two interviews by phone with a clinical reseach assistant at 30 days et 90 days after discharge which consist of questionnaire.


Locations(4)

Hôpital Louis Pradel

Bron, France

Public Health Department

Lyon, France

Hôpital Lyon Sud

Pierre-Bénite, France

SSR Val Rosay

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

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NCT03951467


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