Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Low Health Literacy Prevalence's Study in Patients With Chronic Cardiovascular Disease (LIT-S)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03952013
Recruitment Status : Not yet recruiting
First Posted : May 16, 2019
Last Update Posted : May 16, 2019
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

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.


Condition or disease Intervention/treatment
Cardiovascular Diseases Other: To explore health literacy levels in patients hospitalized for acute neuro-cardiovascular diseases i.e. stroke, myocardial infarction, or heart failure

Layout table for study information
Study Type : Observational
Estimated Enrollment : 720 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Low Health Literacy Prevalence's Study in Patients Hospitalized a Congestive Heart Failure, a Myocardial Infarct, or a Stroke
Estimated Study Start Date : June 2019
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine


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

  • 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)
Other: To explore health literacy levels in patients hospitalized for acute neuro-cardiovascular diseases i.e. stroke, myocardial infarction, or heart failure
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.




Primary Outcome Measures :
  1. 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.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03952013


Contacts
Layout table for location contacts
Contact: Anne-Marie SCHOTT, MD, Prof. 426688241 ext +33 anne-marie.schott-pethelaz@chu-lyon.fr
Contact: Adèle PERRIN, PhD student 426688222 ext +33 adele.perrin@univ-lyon1.fr

Locations
Layout table for location information
France
Hôpital pneumologique et cardiovasculaire Louis Pradel, HCL Not yet recruiting
Bron, France, 69500
Contact: Anne-Marie SCHOTT, MD, Prof.    426688241 ext +33    anne-marie.schott-pethelaz@chu-lyon.fr   
Contact: Adèle PERRIN, PhD student    426688222 ext +33    adele.perrin@univ-lyon1.fr   
Principal Investigator: Anne-Marie SCHOTT, MD, Prof.         
Sub-Investigator: Julie HAESEBAERT, MD         
Sponsors and Collaborators
Hospices Civils de Lyon

Layout table for additonal information
Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03952013     History of Changes
Other Study ID Numbers: LIT-S
First Posted: May 16, 2019    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: May 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Cardiovascular Diseases