Pilot Study of ILIADE : Exploring Health Literacy Within Patients Hospitalized for Acute Cardiovascular Events (P-ILIADE)

Pilot Study of ILIADE: Exploring Health Literacy Within Patients Hospitalized for Acute Cardiovascular Events

Health literacy (HL) 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. An association has been shown between low health literacy and low health outcomes such as increased number of unscheduled hospitalization or emergency visits, low medication adherence and poor health status.

These have been particularly demonstrated with cardiovascular diseases, which combine risk factors (emergency hospitalization, reduction in the length of hospital stays, and complex secondary preventive drug treatments). Despite many scientific international literature about health literacy and health outcomes, no information is available in France on the prevalence of low health literacy level of patients, notably cardiovascular patients. The investigating team's hypothesis is that knowing the prevalence of low HL levels in cardiovascular patients would help to better tailored a communication intervention dedicated to the needs of these low-HL patients with the final aim of increasing their adhesion to preventive drugs and behavioural recommendations.

The first aim of the present study is to estimate the prevalence of low HL level among patients discharged after acute myocardial infarction or acute decompensation of chronic heart failure. Secondary aims are to assess factors associated with the level of HL and identify barriers and facilitators of low HL patients to understand medical information on their disease. The results of this study will guide the design of the intervention of an interventional study on HL of cardiovascular patients.

Study Overview

• Status: Completed
• Conditions: Chronic Heart Failure; Acute Myocardial Infarction
• Intervention / Treatment: Other: Exploring health literacy levels and patients' informal needs or individual relationship between caregivers and patients.

• Study Type: Observational
• Enrollment (Actual): 209

Contacts and Locations

Study Locations

• France
  • Bron, France
    • Groupement Hospitalier Est

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients hospitalized for Acute myocardial infarction (AMI) and acute decompensation of chronic heart failure (CHF) will be screened for one month in the cardiology departments of the Louis Pradel Hospital.

Description

Inclusion Criteria:

- Patient

• Age greater than or equal to 18 years
• Hospitalization for Acute coronary syndrome (ACS) (myocardial infarction with or without ST segment elevation) or acute attack of heart failure (systolic or diastolic)
• Able to communicate in French and/or helping to communicate in French
• Return home after hospitalization

Health professional

• Voluntary and available for the entire interview
• Having participated in the management of the patient screened on the day of the consultation
• Cardiologist, intern or emergency department nurse
• Attached to the participating service

Exclusion Criteria:

- Patient

• Short-term vital prognosis
• Severe dementia
• Inability to manage drug treatment alone
• Institutionalization at the end of hospitalization

Health professional

• Health professional working in the department only one or two days a week
• Health professional who is not specialized in diseases of interest

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Eligible patients; All eligible patients discharged from hospital for Acute Myocardial Infarction (AMI) or acute decompensation of Chronic Heart Failure (CHF)

Other: Exploring health literacy levels and patients' informal needs or individual relationship between caregivers and patients.; It is a cross-sectional study coupled with a qualitative ancillary study conducted within patients hospitalized for one of the two acute cardiovascular diseases (acute coronary syndrome or acute heart failure). All patients hospitalized at Hospices Civils de Lyon for one of these two diseases and whom are going back home will be enrolled. Few patients will be interviewed during the follow-up visit at 1-month post hospitalisation. Caregivers from cardiology units will also be interviewed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Brief Health Literacy Screening (BHLS) of patients hospitalized for a cardiovascular disease.	Health literacy will be measured thanks to the questionnaire Brief Health Literacy Screening (BHLS). This questionnaire is composed of 3 questions and is known to screen quickly patient health literacy. The 3 responses are summed to generate a score between 3 and 15, where higher scores indicated higher health literacy. Low health literacy is defined as Brief Health Literacy Screen less than or equal to a score of 9.	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health Literacy Questionnaire (HLQ)	The HLQ explores more dimensions of health literacy such as social support relationship with caregivers, health information evaluation or ability to engage with caregivers. It consists of 44 items. Participants are asked to rate "How strongly do you disagree or agree with the following statements?". The options provided were: 'strongly disagree', 'disagree', 'agree' and 'strongly agree', which were scored from 1 to 4, respectively. In 2nd part of the HLQ, participants were asked "How easy or difficult are the following tasks for you to do now?" The options for these scales were 'cannot do', 'very difficult', 'quite difficult', 'quite easy' and 'very easy', which were scored from 1 to 5, respectively. The higher the score the higher the health literacy of a patient.	Day 1

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Anne-Marie SCHOTT, PhD, Hospices Civils de Lyon; Study Chair: Julie HAESEBAERT, MD, Hospices Civils de Lyon

Publications and helpful links

General Publications

• Perrin A, Damiolini E, Schott AM, Zermati J, Bravant E, Delahaye F, Dima AL, Haesebaert J. Considering health literacy in cardiovascular disease management: a qualitative study on healthcare professionals' and patients' perspectives. BMC Health Serv Res. 2022 Sep 5;22(1):1121. doi: 10.1186/s12913-022-08455-8.

Study record dates

Study Major Dates

• Study Start (Actual): June 24, 2019
• Primary Completion (Actual): December 12, 2019
• Study Completion (Actual): December 12, 2019

Study Registration Dates

• First Submitted: May 10, 2019
• First Submitted That Met QC Criteria: May 13, 2019
• First Posted (Actual): May 14, 2019

Study Record Updates

• Last Update Posted (Actual): June 22, 2021
• Last Update Submitted That Met QC Criteria: June 17, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction
• Other Study ID Numbers: 69HCL19_0207; 2019-A00799-48 (Other Identifier: ID-RCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No