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

NCT ID: NCT03951467

Last Updated: 2025-07-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-26
• Study Completion Date: 2027-12-26

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.

Conditions

Acute Decompensated Heart Failure; Acute Myocardial Infarction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Interventional arm

Group Type: EXPERIMENTAL

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

Intervention Type: OTHER

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.

Controlled arm

Patients within this arm will be follow as usual care of the cardiologic unit

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Interventional 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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Julie HAESEBAERT, MD

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Locations

Hôpital Louis Pradel

Bron, , France

Site Status: RECRUITING

Public Health Department

Lyon, , France

Site Status: RECRUITING

Hôpital Lyon Sud

Pierre-Bénite, , France

Site Status: RECRUITING

SSR Val Rosay

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

Site Status: RECRUITING

Countries

France

Central Contacts

Julie HAESEBAERT, MD

Role: CONTACT

julie.haesebaert@chu-lyon.fr

04 72 68 49 05 ext. +33

Estelle BRAVANT

Role: CONTACT

estelle.bravant@chu-lyon.fr

04 27 85 63 18 ext. +33

Facility Contacts

Nathan MEWTON,

Role: primary

nathan.mewton@chu-lyon.fr

04 72 35 58 65

Julie HAESEBAERT, MD

Role: primary

julie.haesebaert@chu-lyon.fr

04 72 68 49 05 ext. +33

Estelle BRAVANT

Role: backup

estelle.bravant@chu-lyon.fr

04 27 85 63 18 ext. +33

Pierre-Yves, COURAND,

Role: primary

pierre-yves.courand@chu-lyon.fr

04 78 86 57 37

Nathalie CHARLOTTE,

Role: primary

04 72 53 20 22 ext. nathalie.charl

Other Identifiers

69HCL19_0035

Identifier Type: -

Identifier Source: org_study_id