Acute Myocardial InfarctionP-ILIADENCT03949309
Pilot Study of ILIADE : Exploring Health Literacy Within Patients Hospitalized for Acute Cardiovascular Events
An observational study of Acute Myocardial Infarction and Chronic Heart Failure, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myocardial Infarction, Chronic Heart Failure
- What is being tested?
- Exploring health literacy levels and patients' informal needs or individual relationship between caregivers and patients.
- How many people
- 209 participants
- Where
- 1 siteFrance
- Study dates
- 24 Jun 2019to 12 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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
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.
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Acute Myocardial Infarction, Chronic Heart Failure
- Being tested
- Exploring health literacy levels and patients' informal needs or individual relationship between caregivers and patients.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exploring health literacy levels and patients' informal needs or individual relationship between caregivers and patients.Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Eligible patients | All eligible patients discharged from hospital for Acute Myocardial Infarction (AMI) or acute decompensation of Chronic Heart Failure (CHF) Receives: Other: Exploring health literacy levels and patients' informal needs or individual relationship between caregivers and patients. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
Secondary outcomes (1)
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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2019
- Study start24 Jun 2019
- Primary completion12 Dec 2019
- Study completion12 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Myocardial InfarctionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 209 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne-Marie SCHOTT, PhD, Principal investigator, Hospices Civils de LyonJulie HAESEBAERT, MD, Study chair, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03949309
- Sponsor's protocol ID
- 69HCL19_0207
- Other IDs
- 2019-A00799-48
- Acronym
- P-ILIADE
- Status last verified
- Jun 2021
- First submitted
- 10 May 2019
- Last updated
- 22 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 36064395
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of ILIADE: Exploring Health Literacy Within Patients Hospitalized for Acute Cardiovascular Events
- ClinicalTrials.gov ID
- NCT03949309
- Acronym / sponsor ID
- P-ILIADE / 69HCL19_0207
- Conditions
- Acute Myocardial Infarction, Chronic Heart Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 209 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 24 Jun 2019 (actual)
- Primary completion
- 12 Dec 2019 (actual)
- Study completion
- 12 Dec 2019 (actual)
- First posted
- 14 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 (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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Eligible patients | – | Other: Exploring health literacy levels and patients' informal needs or individual relationship between caregivers and patients.All eligible patients discharged from hospital for Acute Myocardial Infarction (AMI) or acute decompensation of Chronic Heart Failure (CHF) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (8 listed)
- Patient
- Short-term vital prognosis
- Severe dementia
- Inability to manage drug treatment alone
- Institutionalization at the end of hospitalization
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 |
|---|---|---|
| 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. | Other | Eligible patients |
Primary outcome
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.
1 secondary outcome
Health Literacy Questionnaire (HLQ)
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2021.
- Derived from this study: PubMed 36064395Perrin 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.
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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. This study is not recruiting at the moment.
Anne-Marie SCHOTT, PhD principal investigator
Hospices Civils de Lyon
Julie HAESEBAERT, MD study chair
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myocardial Infarction and Chronic Heart Failure, run by Hospices Civils de Lyon at 1 site 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 10 inclusion and 8 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: finished, as of the sponsor's last update on 22 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brief Health Literacy Screening (BHLS) of patients hospitalized for a cardiovascular disease. (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03949309, which also lists 1 linked publication.
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 22 Jun 2021.