- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03952013
Low Health Literacy Prevalence's Study in Patients With Chronic Cardiovascular Disease (LIT-S)
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.
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 Overview
Status
Conditions
Study Type
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
At 2 months after study participation acceptation
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LIT-S
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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