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Clinical Trials/NCT03952013
NCT03952013
Withdrawn
Not Applicable

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

Hospices Civils de Lyon0 sitesJuly 19, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiovascular Diseases
Sponsor
Hospices Civils de Lyon
Primary Endpoint
Health literacy levels measured by BHLS
Status
Withdrawn
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 19, 2019
End Date
December 17, 2020
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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:
  • 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

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
  • 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)

Outcomes

Primary Outcomes

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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