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临床试验/NCT03952013
NCT03952013撤回不适用

Low Health Literacy Prevalence's Study in Patients Hospitalized a Congestive Heart Failure, a Myocardial Infarct, or a Stroke

Hospices Civils de Lyon0 个研究点开始时间: 2019年7月19日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
主要终点
Health literacy levels measured by BHLS

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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:
  • 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.

排除标准

  • 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
  • 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)

结局指标

主要结局

Health literacy levels measured by BHLS

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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