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 |
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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 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 |
Group/Cohort | Intervention/treatment |
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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
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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.
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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.
Ages Eligible for Study: | 18 Years to 90 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
LOOP-HF
HIBISCUS-STROKE
HIBISCUS-STEMI
Exclusion Criteria:
LOOP-HF
HIBISCUS-STROKE
HIBISCUS-STEMI
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 |
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 |
Tracking Information | |||||
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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 |
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.
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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. |
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Detailed Description | Not Provided | ||||
Study Type | Observational | ||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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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.
|
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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
Intervention: Other: To explore health literacy levels in patients hospitalized for acute neuro-cardiovascular diseases i.e. stroke, myocardial infarction, or heart failure
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Unknown status | ||||
Estimated Enrollment |
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:
LOOP-HF
HIBISCUS-STROKE
HIBISCUS-STEMI
Exclusion Criteria:
LOOP-HF
HIBISCUS-STROKE
HIBISCUS-STEMI
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Sex/Gender |
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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 |
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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 |