Education tailored to your health literacy to help follow heart-care instructions after a heart attack or heart failure
Official title: 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
Run by Hospices Civils de Lyon · NCT03951467 · Data updated 2026-11-12
This trial tests whether an educational toolkit adapted for people with limited health literacy helps patients hospitalized for a heart attack or worsening heart failure follow medical recommendations and avoid readmission.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | Hospices Civils de Lyon Academic / other |
| Locations | 4 sites (Bron and 3 other locations) |
| Status | Recruiting |
| Started | June 26, 2025 |
| Main results expected | December 26, 2027 |
| Study ends | December 26, 2027 |
| Registry record updated | July 14, 2025 |
| Trial ID | NCT03951467 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18) hospitalized for an acute myocardial infarction or a recurrent episode of decompensated heart failure who lived at home before admission, are affiliated with health insurance, and have limited health literacy (S-TOFHLA ≤22) are the intended participants.
✕Probably not a fit
People with adequate health literacy (S-TOFHLA >22), severe dementia or active psychosis, a short-term vital prognosis, pregnancy, legal incapacity, or other exclusion criteria are not eligible and unlikely to benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized interventional trial enrolls adults hospitalized for an acute myocardial infarction or acute decompensated heart failure who have limited health literacy. Participants are randomized to receive usual discharge care or an educational toolkit co-designed with patients and health professionals that is adapted to low health literacy. The toolkit focuses on clear written materials and practical instructions to improve medication taking and follow-up behaviors. The study tracks adherence to medical recommendations and subsequent healthcare use after discharge.
Why it matters
Potential benefit: If successful, the intervention could improve medication adherence and reduce rehospitalizations for patients with limited health literacy after acute cardiac events.
How similar studies have gone: Some prior studies of health-literacy–adapted education have shown improvements in adherence and reduced readmissions, but results are mixed and randomized evidence remains limited.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Hôpital Louis Pradel
Bron, France Recruiting -
Public Health Department
Lyon, France Recruiting -
Hôpital Lyon Sud
Pierre-Bénite, France Recruiting -
SSR Val Rosay
Saint-Didier-au-Mont-d'Or, France Recruiting
Study contacts
- Principal investigator: Julie HAESEBAERT, MD — Hospices Civils de Lyon
- Study coordinator: Julie HAESEBAERT, MD
- Email: julie.haesebaert@chu-lyon.fr
- Phone: 04 72 68 49 05
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.