Acute Decompensated Heart FailureILIADENCT03951467
Using an Intervention Adapted to the Health Literacy Level to Improve Adherence to Medical Recommendations
A study testing Interventional educational toolkit specific to low Health Literacy patients, designed with patients and health professionals. in people with Acute Decompensated Heart Failure and Acute Myocardial Infarction, run by Hospices Civils de Lyon at 4 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Decompensated Heart Failure, Acute Myocardial Infarction
- What is being tested?
- Interventional educational toolkit specific to low Health Literacy patients, designed with patients and health professionals.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 4 sitesFrance
- Study dates
- 26 Jun 2025to 26 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France4 sites, 4 recruiting
- Recruiting
Hôpital Louis Pradel
Bron, 69500
Nathan MEWTON,, 04 72 35 58 65, nathan.mewton@chu-lyon.fr
- Recruiting
Public Health Department
Lyon
Julie HAESEBAERT, MD, 04 72 68 49 05 ext. +33, julie.haesebaert@chu-lyon.fr
Estelle BRAVANT, 04 27 85 63 18 ext. +33, estelle.bravant@chu-lyon.fr
- Recruiting
Hôpital Lyon Sud
Pierre-Bénite, 69495
Pierre-Yves, COURAND,, 04 78 86 57 37, pierre-yves.courand@chu-lyon.fr
- Recruiting
SSR Val Rosay
Saint-Didier-au-Mont-d'Or, 69370
Nathalie CHARLOTTE,, 04 72 53 20 22 ext. nathalie.charl
About this study
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
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.
Read more
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.
- Being tested
- Interventional educational toolkit specific to low Health Literacy patients, designed with patients and health professionals.
- Keywords
- Literacy, Cardiovascular Diseases, Interventional study, Randomized Controlled Trial, Tertiary prevention, Health promotion
- Medical subject headings
- Literacy, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Interventional arm | Experimental | Not described Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2019
- Study start26 Jun 2025
- Primary completion26 Dec 2027 (estimated)
- Study completion26 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Decompensated Heart FailureStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julie HAESEBAERT, MD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03951467
- Sponsor's protocol ID
- 69HCL19_0035
- Acronym
- ILIADE
- Status last verified
- Jul 2025
- First submitted
- 14 May 2019
- Last updated
- 14 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03951467
- Acronym / sponsor ID
- ILIADE / 69HCL19_0035
- Keywords
- Literacy, Cardiovascular Diseases, Interventional study, Randomized Controlled Trial, Tertiary prevention, Health promotion
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 26 Jun 2025 (actual)
- Primary completion
- 26 Dec 2027 (estimated)
- Study completion
- 26 Dec 2027 (estimated)
- First posted
- 15 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Interventional arm |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Julie HAESEBAERT, MD principal investigator
Hospices Civils de Lyon
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interventional educational toolkit specific to low Health Literacy patients, designed with patients and health professionals. in people with Acute Decompensated Heart Failure and Acute Myocardial Infarction, run by Hospices Civils de Lyon at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julie HAESEBAERT, MD (04 72 68 49 05 ext. +33, julie.haesebaert@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-related medication errors or misuse within 30 days of discharge from hospital. (time frame: Day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2025.