Education tailored to your health literacy to help follow heart-care instructions after a heart attack or heart failure
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
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospices Civils de Lyon Academic / other |
| Locations | 4 sites (Bron and 3 other locations) |
| Trial ID | NCT03951467 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Bron and 3 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.