Clinical trial NCT03952013: Low Health Literacy Prevalence's Study in Patients With Chronic Cardiovascular Disease
Official title: Low Health Literacy Prevalence's Study in Patients Hospitalized a Congestive Heart Failure, a Myocardial Infarct, or a Stroke
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Cardiovascular Diseases
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2019-05-16
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All HCL patients in the LOOP-HF, HIBISCUS-STEMI and HIBISCUS-STROKE cohorts may be included and will constitute the study population.

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 (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.


Eligibility criteria: Inclusion Criteria:

* 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
* 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.

Exclusion Criteria:

* 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
* 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)

Primary outcomes:
measure: Health literacy levels measured by BHLS
timeFrame: At 2 months after study participation acceptation
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: