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出境医 / 临床实验 / Low Health Literacy Prevalence's Study in Patients With Chronic Cardiovascular Disease (LIT-S)

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

Study Description
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

Study Design
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
Arms 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

  • 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.

Outcome Measures
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.



Eligibility Criteria
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)
Contacts and Locations

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
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
Tracking Information
First Submitted Date May 14, 2019
First Posted Date May 16, 2019
Last Update Posted Date May 16, 2019
Estimated Study Start Date June 2019
Estimated Primary Completion Date October 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 14, 2019)
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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Cardiovascular Diseases
Intervention 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.
Study Groups/Cohorts 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)
Intervention: Other: To explore health literacy levels in patients hospitalized for acute neuro-cardiovascular diseases i.e. stroke, myocardial infarction, or heart failure
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: May 14, 2019)
720
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 2019
Estimated Primary Completion Date October 2019   (Final data collection date for primary outcome measure)
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)
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03952013
Other Study ID Numbers LIT-S
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Hospices Civils de Lyon
Study Sponsor Hospices Civils de Lyon
Collaborators Not Provided
Investigators Not Provided
PRS Account Hospices Civils de Lyon
Verification Date May 2019