Cardiovascular DiseasesLIT-SNCT03952013
Low Health Literacy Prevalence's Study in Patients With Chronic Cardiovascular Disease
An observational study of Cardiovascular Diseases, run by Hospices Civils de Lyon.
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 (HL) is known as a health determinant. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- To explore health literacy levels in patients hospitalized for acute neuro-cardiovascular diseases i.e. stroke, myocardial infarction, or heart failure
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 19 Jul 2019to 17 Dec 2020
- 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 to 90 years
- All sexes
- Adult, Older adult
Study population: All HCL patients in the LOOP-HF, HIBISCUS-STEMI and HIBISCUS-STROKE cohorts may be included and will constitute the study population.
Who may be able to join
- Age ≥ 18 years
- Can be reached by phone (telephone numbers will be obtained through cohorts)
- Included in one of the 3 cohorts LOOP-HF (Heart Failure), HIBISCUS (stroke and myocardial infarction) with the following eligibility criteria:
- LOOP-HF
- Patient with congestive heart failure confirmed after at the end of: Hospitalization for congestive cardiac decompensation, Follow-up for stable congestive heart failure in consultation with at least one episode of cardiac decompensation within the year
- NT-proBNP > 500ng/l in the month before inclusion
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- New York Heart Association (NYHA) ≥ 2
- Age > 18 years old
- Signature informed consent
- HIBISCUS-STROKE
- Age > 18 years old
- Diagnosis of ischemic cerebral infarction confirmed by brain imaging
- Visible proximal occlusion on brain imaging (ACI or M1)
- Patient treated with thrombolysis and/or thrombectomy
- Signature of consent by the patient or family member
- HIBISCUS-STEMI
- Age > 18 years old
- STEMI diagnosis defined by an elevation of the ST segment ≥ 0.2 mV in 2 leads contiguous on a 12-lead ECG.
- Percutaneous coronary intervention (PCI)
- Obtaining informed and signed consent obtained or oral consent attested by a third party.
Who cannot join
- Announcing an opposition to the study (an information letter will be sent to patients at home and their non-opposition to the study will be considered if the patient does not contact the coordination centre)
- Not speaking French
- LOOP-HF
- Life expectancy < 1 year
- Patient over 90 years of age
- Recent discovery of heart failure (< 3 months) long-term assisted or cardiac transplant patient
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- Inability to provide the patient with informed information
- Loss of autonomy, dementia, major dependence
- Lack of coverage by the social security system
- HIBISCUS-STROKE
- Patients > 50 km from Pierre Wertheimer Hospital (follow-up in Lyon impossible)
- Patient for whom H0 sampling is not possible (telemedicine)
- Patient with active or uncontrolled cancer.
- Stroke of unknown schedule
- Lack of coverage by a Social Security scheme
- Deprivation of civil rights (guardianship, guardianship, protection of justice)
- HIBISCUS-STEMI
- Unconfirmed STEMI diagnosis in angiography
- Refusal to participate in the study or to sign the consent
- Inability to provide informed information about the subject
- Lack of coverage by a Social Security scheme
- Clear contraindication to magnetic resonance imaging (claustrophobia, pacemaker, defibrillator, renal failure, known allergy to a product of contrast...)
- Deprivation of civil rights (guardianship, guardianship, protection of justice)
About this study
Official title: Low Health Literacy Prevalence's Study in Patients Hospitalized a Congestive Heart Failure, a Myocardial Infarct, or a Stroke
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 (HL) is known as a health determinant.
An association has been shown between low HL and poorer health outcomes such as increased number of unscheduled hospitalisation or emergency visits, low medication adherence and poor health status.
Read more
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 large scientific international literature about HL and health outcomes, no information is available in France on the prevalence of low HL level among patients managed for neuro-cardio-vascular diseases.
It has been shown in other countries that healthcare professionals overestimate the HL level of their patients and do not adapt information to the HL level. Therefore, patients with low HL do not understand and/or are not able to use properly the information they receive.
Having a better knowledge of HL level and characteristics in these patients is necessary to develop tools for helping healthcare professionals to identify patients with low HL level and to realize the role of HL as a determinant of health. It will also provide more precise information on the difficulties or needs of patients with different levels of health literacy.
- Conditions
- Cardiovascular Diseases
- Being tested
- To explore health literacy levels in patients hospitalized for acute neuro-cardiovascular diseases i.e. stroke, myocardial infarction, or heart failure
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
To explore health literacy levels in patients hospitalized for acute neuro-cardiovascular diseases i.e. stroke, myocardial infarction, or heart failureOther
All patients included and followed within one of the three cohorts studies: LOOP-HF, HIBISCUS-STEMI and HIBISCUS-STROKE who accepted to participate in the study, will be contacted by phone (attempted calls are set to 3 to reach the patient), mail or during a consultation, to answer to a health literacy questionnaire. The patient will participate in the study only once. The estimated duration is therefore estimated at 1 day for each patient and two month for the study. Thanks to the many following periods within the cohorts (6 months, 1 year and 18 month), we will measure health literacy at different times of the care.
| Study group | Role | What they receive |
|---|---|---|
| Study group | All eligible patients included into one of the three existing cohorts studies of Hospices Civils de Lyon's hospitals: LOOP-HF, HIBISCUS-STEMI and HIBISCUS-STROKE
* LOOP-HF (Registry of Congestive Heart Failure, NCT03422991),
* HIBISCUS-STEMI (Prospective cohort with a heart attack from ST segment elevation myocardium admitted to the centre coronary angiography room participating investigators, NCT03070496)
* HIBISCUS-STROKE (Prospective cohort of Stroke patients, NCT03149705) Receives: Other: To explore health literacy levels in patients hospitalized for acute neuro-cardiovascular diseases i.e. stroke, myocardial infarction, or heart failure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health literacy levels measured by BHLS
Health literacy will be measured using the Brief Health Literacy Screening (BHLS) questionnaire.
The BHLS is known to screen quickly health literacy with 3 questions corresponding to 3 dimensions of the Health and Labour Questionnaire (HLQ): Enough information to manage health, Ability to actively engage with healthcare providers and Sufficient understanding to know what to do.
Measured: At 2 months after study participation acceptation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2019
- Study start19 Jul 2019
- Primary completion17 Dec 2020
- Study completion17 Dec 2020 (estimated)
Why it stopped: COVID-19 : departure of investigative staff
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03952013
- Sponsor's protocol ID
- LIT-S
- Acronym
- LIT-S
- Status last verified
- Aug 2022
- First submitted
- 14 May 2019
- Last updated
- 22 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Health Literacy Prevalence's Study in Patients Hospitalized a Congestive Heart Failure, a Myocardial Infarct, or a Stroke
- ClinicalTrials.gov ID
- NCT03952013
- Acronym / sponsor ID
- LIT-S / LIT-S
- Conditions
- Cardiovascular Diseases
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: COVID-19 : departure of investigative staff
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 19 Jul 2019 (actual)
- Primary completion
- 17 Dec 2020 (actual)
- Study completion
- 17 Dec 2020 (estimated)
- First posted
- 16 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 (HL) is known as a health determinant.
An association has been shown between low HL and poorer health outcomes such as increased number of unscheduled hospitalisation 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 large scientific international literature about HL and health outcomes, no information is available in France on the prevalence of low HL level among patients managed for neuro-cardio-vascular diseases.
It has been shown in other countries that healthcare professionals overestimate the HL level of their patients and do not adapt information to the HL level. Therefore, patients with low HL do not understand and/or are not able to use properly the information they receive.
Having a better knowledge of HL level and characteristics in these patients is necessary to develop tools for helping healthcare professionals to identify patients with low HL level and to realize the role of HL as a determinant of health. It will also provide more precise information on the difficulties or needs of patients with different levels of health literacy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Other: To explore health literacy levels in patients hospitalized for acute neuro-cardiovascular diseases i.e. stroke, myocardial infarction, or heart failureAll eligible patients included into one of the three existing cohorts studies of Hospices Civils de Lyon's hospitals: LOOP-HF, HIBISCUS-STEMI and HIBISCUS-STROKE * LOOP-HF (Registry of Congestive Heart Failure, NCT03422991), * HIBISCUS-STEMI (Prospective cohort with a heart attack from ST segment elevation myocardium admitted to the centre coronary angiography room participating investigators, NCT03070496) * HIBISCUS-STROKE (Prospective cohort of Stroke patients, NCT03149705) |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All HCL patients in the LOOP-HF, HIBISCUS-STEMI and HIBISCUS-STROKE cohorts may be included and will constitute the study population.
Key inclusion criteria (20 listed)
- Age ≥ 18 years
- Can be reached by phone (telephone numbers will be obtained through cohorts)
- Included in one of the 3 cohorts LOOP-HF (Heart Failure), HIBISCUS (stroke and myocardial infarction) with the following eligibility criteria:
- LOOP-HF
- Patient with congestive heart failure confirmed after at the end of: Hospitalization for congestive cardiac decompensation, Follow-up for stable congestive heart failure in consultation with at least one episode of cardiac decompensation within the year
Key exclusion criteria (23 listed)
- Announcing an opposition to the study (an information letter will be sent to patients at home and their non-opposition to the study will be considered if the patient does not contact the coordination centre)
- Not speaking French
- LOOP-HF
- Life expectancy < 1 year
- Patient over 90 years of age
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 |
|---|---|---|
| To explore health literacy levels in patients hospitalized for acute neuro-cardiovascular diseases i.e. stroke, myocardial infarction, or heart failureAll patients included and followed within one of the three cohorts studies: LOOP-HF, HIBISCUS-STEMI and HIBISCUS-STROKE who accepted to participate in the study, will be contacted by phone (attempted calls are set to 3 to reach the patient), mail or during a consultation, to answer to a health literacy questionnaire. The patient will participate in the study only once. The estimated duration is therefore estimated at 1 day for each patient and two month for the study. Thanks to the many following periods within the cohorts (6 months, 1 year and 18 month), we will measure health literacy at different times of the care. | Other | Study group |
Primary outcome
Health literacy levels measured by BHLS
Time frame: At 2 months after study participation acceptation
Health literacy will be measured using the Brief Health Literacy Screening (BHLS) questionnaire. The BHLS is known to screen quickly health literacy with 3 questions corresponding to 3 dimensions of the Health and Labour Questionnaire (HLQ): Enough information to manage health, Ability to actively engage with healthcare providers and Sufficient understanding to know what to do.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases, run by Hospices Civils de Lyon.
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 20 inclusion and 23 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: withdrawn, as of the sponsor's last update on 22 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Health literacy levels measured by BHLS (time frame: At 2 months after study participation acceptation). 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 22 Aug 2022.