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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03949309
Recruitment Status : Not yet recruiting
First Posted : May 14, 2019
Last Update Posted : May 14, 2019
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief Summary:

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.

Condition or disease Intervention/treatment
Acute Myocardial Infarction Chronic Heart Failure Other: Exploring health literacy levels and patients' informal needs or individual relationship between caregivers and patients.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pilot Study of ILIADE: Exploring Health Literacy Within Patients Hospitalized for Acute Cardiovascular Events
Estimated Study Start Date : June 1, 2019
Estimated Primary Completion Date : July 1, 2019
Estimated Study Completion Date : August 1, 2019

Resource links provided by the National Library of Medicine

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.

Primary Outcome Measures :
  1. Brief Health Literacy Screening (BHLS) of patients hospitalized for a cardiovascular disease. [ Time Frame: Day 1 ]
    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.

Secondary Outcome Measures :
  1. Health Literacy Questionnaire (HLQ) [ Time Frame: Day 1 ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03949309

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Contact: Anne-Marie SCHOTT, PhD 4 26 68 82 41 ext 33
Contact: Adèle PERRIN 4 26 68 82 22 ext 33

Sponsors and Collaborators
Hospices Civils de Lyon
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Principal Investigator: Anne-Marie SCHOTT, PhD Hospices Civils de Lyon
Study Chair: Julie HAESEBAERT, MD Hospices Civils de Lyon
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Responsible Party: Hospices Civils de Lyon Identifier: NCT03949309    
Other Study ID Numbers: 69HCL19_0207
2019-A00799-48 ( Other Identifier: ID-RCB )
First Posted: May 14, 2019    Key Record Dates
Last Update Posted: May 14, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Myocardial Infarction
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Myocardial Ischemia
Vascular Diseases