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

NCT03951467 | Recruiting

• 1 other identifier: 69HCL19_0035
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 4

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

Keywords

Literacy; Cardiovascular Diseases; Interventional study; Randomized Controlled Trial; Tertiary prevention; Health promotion

Outcome Measures

Primary Outcomes (1)

• Patient-related medication errors or misuse within 30 days of discharge from hospital.

  This criterion is defined as the proportion of patients who have made a medication error or misuse, with or without a clinical consequence. We will focus on patient-related medication errors and misuse, i.e. non-compliance with prescription (shorter or longer treatment time, dosage changes, self-medication, etc.), based on the definition proposed by Kripalani et al. An adjudication committee composed of three independent experts will be responsible for defining the potential severity of drug errors or misuses related to the main judgement criterion. Data on primary endpoint will be collected by a clinical researcher, blinded to the randomization group, using a standardized questionnaire administered during the 30-day telephone interview. The patient will be asked the names of the treatments, how he/she took them (number of units per intake, frequency of intake,...), self-medication taken and medical follow-up (medical consultations, biological follow-up,...) over the past 30 days.

  Day 30

Study Arms (2)

Interventional arm

EXPERIMENTAL

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

Controlled arm

NO INTERVENTION

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

Interventions

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

Interventional arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Short-term vital prognosis
• Bipolar disorders, active psychoses
• Severe dementia
• 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)
• Score S-TOFHLA (\>22)
• Withdrawal of consent

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (4)

Hôpital Louis Pradel

Bron, 69500, France

RECRUITING

Public Health Department

Lyon, France

RECRUITING

Hôpital Lyon Sud

Pierre-Bénite, 69495, France

RECRUITING

SSR Val Rosay

Saint-Didier-au-Mont-d'Or, 69370, France

RECRUITING

MeSH Terms

Conditions

Literacy; Cardiovascular Diseases

Interventions

Health Personnel

Condition Hierarchy (Ancestors)

Communication; Behavior

Intervention Hierarchy (Ancestors)

Health Care Facilities Workforce and Services

Study Officials

• Julie HAESEBAERT, MD

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julie HAESEBAERT, MD

CONTACT

04 72 68 49 05; julie.haesebaert@chu-lyon.fr

Estelle BRAVANT

CONTACT

04 27 85 63 18; estelle.bravant@chu-lyon.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2019
• First Posted: May 15, 2019
• Study Start: June 26, 2025
• Primary Completion (Estimated): December 26, 2027
• Study Completion (Estimated): December 26, 2027
• Last Updated: July 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)