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Recruiting NCT03951467

NCT03951467 Using an Intervention Adapted to the Health Literacy Level to Improve Adherence to Medical Recommendations

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Clinical Trial Summary
NCT ID NCT03951467
Status Recruiting
Phase
Sponsor Hospices Civils de Lyon
Condition Acute Decompensated Heart Failure
Study Type INTERVENTIONAL
Enrollment 300 participants
Start Date 2025-06-26
Primary Completion 2027-12-26

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age N/A
Study Type INTERVENTIONAL
Interventions
Interventional educational toolkit specific to low Health Literacy patients, designed with patients and health professionals.

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 300 participants in total. It began in 2025-06-26 with a primary completion date of 2027-12-26.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief 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 Criteria

Inclusion Criteria: * Age greater than or equal to 18 years * Hospitalization for at least a 2nd acute attack (systolic or diastolic) * Patient living at home before hospitalization for decompensation * Affiliated with a health insurance plan Exclusion Criteria: * Short-term vital prognosis * Bipolar disorders, active psychoses * Severe dementia * Psychiatric or cognitive comorbidities making inclusion impossible, at the discretion of the investigator. * Pregnant, parturient or breastfeeding women * Persons deprived of liberty by a judicial or administrative decision * Persons admitted to a health or social establishment for purposes other than research * Adults subject to a legal protection measure (guardianship, curatorship) * Subject participating in another interventional research including an exclusion period still ongoing at inclusion * Score S-TOFHLA (\>22) * Withdrawal of consent

Contact & Investigator

Central Contact

Julie HAESEBAERT, MD

✉ julie.haesebaert@chu-lyon.fr

📞 04 72 68 49 05

Principal Investigator

Julie HAESEBAERT, MD

PRINCIPAL INVESTIGATOR

Hospices Civils de Lyon

Frequently Asked Questions

Who can join the NCT03951467 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Decompensated Heart Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT03951467 currently recruiting?

Yes, NCT03951467 is actively recruiting participants. Contact the research team at julie.haesebaert@chu-lyon.fr for enrollment information.

Where is the NCT03951467 trial being conducted?

This trial is being conducted at Bron, France, Lyon, France, Pierre-Bénite, France, Saint-Didier-au-Mont-d'Or, France.

Who is sponsoring the NCT03951467 clinical trial?

NCT03951467 is sponsored by Hospices Civils de Lyon. The principal investigator is Julie HAESEBAERT, MD at Hospices Civils de Lyon. The trial plans to enroll 300 participants.

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ClinicalMetric — Independent clinical trial intelligence platform. Not affiliated with NIH, ClinicalTrials.gov, the U.S. FDA, or any pharmaceutical company, hospital, or clinical research organization. Trial data is sourced from ClinicalTrials.gov for informational purposes only and does not constitute medical advice. Do not make any treatment, enrollment, or health decisions based solely on information found here — always consult a qualified healthcare professional. Full Disclaimer  ·  Last Reviewed: July 2026  ·  Data Methodology