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Using an Intervention Adapted to the Health Literacy Level to Improve Adherence to Medical Recommendations (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: NCT03951467
Recruitment Status : Not yet recruiting
First Posted : May 15, 2019
Last Update Posted : May 15, 2019
Information provided by (Responsible Party):
Hospices Civils de Lyon

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 (HL) 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 LS in health inequalities, regardless of the region of the world.

We chose to conduct this study in patients hospitalized for an acute cardiovascular event: acute myocardial infarction (AMI) or acute decompensated heart failure (ADHF), 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 HL. The proportion of patients with preventable ADR in the weeks following their return home ranges from 23% to 30% and nearly 60% are re-hospitalized within 6 months.

Our hypothesis is that in patients hospitalized for AMI or ADHF with low HL 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 HL 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.

Condition or disease Intervention/treatment Phase
Acute Decompensated Heart Failure Acute Myocardial Infarction Other: Interventional educational toolkit specific to low Health Literacy patients, designed with patients and health professionals. Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 576 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: 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
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : March 2023

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Interventional arm Other: Interventional educational toolkit specific to low Health Literacy patients, designed with patients and health professionals.

Two interviews between the patient and the nurse trained for the study: before discharge from hospital and a telephone reminder between 3 and 5 days after discharge.

First 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: 3 to 5 days 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.

No Intervention: Controlled arm
Patients within this arm will be follow as usual care of the cardiologic unit

Primary Outcome Measures :
  1. Patient-related medication errors or misuse within 30 days of discharge from hospital. [ Time Frame: Day 30 ]

    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.

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

Inclusion Criteria:

  • Inadequate health literacy level according to the Brief Health Literacy Screening questionnaire
  • Age greater than or equal to 18 years
  • Hospitalization for acute myocardial infarction (myocardial infarction with or without ST segment elevation) or acute decompensated heart failure (systolic or diastolic)
  • Return home after hospitalization
  • Affiliated with a health insurance plan

Exclusion Criteria:

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

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): NCT03951467

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Contact: Julie HAESEBAERT, MD 04 72 68 49 05 ext +33
Contact: Estelle BRAVANT 04 27 85 63 18 ext +33

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Public Health Department Not yet recruiting
Lyon, France
Contact: Julie HAESEBAERT, MD    04 72 68 49 05 ext +33   
Contact: Estelle BRAVANT    04 27 85 63 18 ext +33   
Principal Investigator: Julie HAESEBAERT, MD         
Sponsors and Collaborators
Hospices Civils de Lyon
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Principal Investigator: Julie HAESEBAERT, MD Hospices Civils de Lyon

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Responsible Party: Hospices Civils de Lyon Identifier: NCT03951467     History of Changes
Other Study ID Numbers: 69HCL19_0035
First Posted: May 15, 2019    Key Record Dates
Last Update Posted: May 15, 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

Keywords provided by Hospices Civils de Lyon:
Cardiovascular Diseases
Interventional study
Randomized Controlled Trial
Tertiary prevention
Health promotion

Additional relevant MeSH terms:
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Heart Failure
Myocardial Infarction
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Myocardial Ischemia
Vascular Diseases