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Pilot Study of ILIADE : Exploring Health Literacy Within Patients Hospitalized for Acute Cardiovascular Events (P-ILIADE)
Health literacy (HL) 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 is known as a health determinant. An association has been shown between low health literacy and low health outcomes such as increased number of unscheduled hospitalization 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 many scientific international literature about health literacy and health outcomes, no information is available in France on the prevalence of low health literacy level of patients, notably cardiovascular patients. The investigating team's hypothesis is that knowing the prevalence of low HL levels in cardiovascular patients would help to better tailored a communication intervention dedicated to the needs of these low-HL patients with the final aim of increasing their adhesion to preventive drugs and behavioural recommendations.
The first aim of the present study is to estimate the prevalence of low HL level among patients discharged after acute myocardial infarction or acute decompensation of chronic heart failure. Secondary aims are to assess factors associated with the level of HL and identify barriers and facilitators of low HL patients to understand medical information on their disease. The results of this study will guide the design of the intervention of an interventional study on HL of cardiovascular patients.
| Condition or disease | Intervention/treatment |
|---|---|
| Acute Myocardial Infarction Chronic Heart Failure | Other: Exploring health literacy levels and patients' informal needs or individual relationship between caregivers and patients. |
| Study Type : | Observational |
| Estimated Enrollment : | 100 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Pilot Study of ILIADE: Exploring Health Literacy Within Patients Hospitalized for Acute Cardiovascular Events |
| Estimated Study Start Date : | June 1, 2019 |
| Estimated Primary Completion Date : | July 1, 2019 |
| Estimated Study Completion Date : | August 1, 2019 |
| Group/Cohort | Intervention/treatment |
|---|---|
|
Eligible patients
All eligible patients discharged from hospital for Acute Myocardial Infarction (AMI) or acute decompensation of Chronic Heart Failure (CHF)
|
Other: Exploring health literacy levels and patients' informal needs or individual relationship between caregivers and patients.
It is a cross-sectional study coupled with a qualitative ancillary study conducted within patients hospitalized for one of the two acute cardiovascular diseases (acute coronary syndrome or acute heart failure). All patients hospitalized at Hospices Civils de Lyon for one of these two diseases and whom are going back home will be enrolled. Few patients will be interviewed during the follow-up visit at 1-month post hospitalisation. Caregivers from cardiology units will also be interviewed.
|
- Brief Health Literacy Screening (BHLS) of patients hospitalized for a cardiovascular disease. [ Time Frame: Day 1 ]Health literacy will be measured thanks to the questionnaire Brief Health Literacy Screening (BHLS). This questionnaire is composed of 3 questions and is known to screen quickly patient health literacy. The 3 responses are summed to generate a score between 3 and 15, where higher scores indicated higher health literacy. Low health literacy is defined as Brief Health Literacy Screen less than or equal to a score of 9.
- Health Literacy Questionnaire (HLQ) [ Time Frame: Day 1 ]The HLQ explores more dimensions of health literacy such as social support relationship with caregivers, health information evaluation or ability to engage with caregivers. It consists of 44 items. Participants are asked to rate "How strongly do you disagree or agree with the following statements?". The options provided were: 'strongly disagree', 'disagree', 'agree' and 'strongly agree', which were scored from 1 to 4, respectively. In 2nd part of the HLQ, participants were asked "How easy or difficult are the following tasks for you to do now?" The options for these scales were 'cannot do', 'very difficult', 'quite difficult', 'quite easy' and 'very easy', which were scored from 1 to 5, respectively. The higher the score the higher the health literacy of a patient.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Patient
- Age greater than or equal to 18 years
- Hospitalization for Acute coronary syndrome (ACS) (myocardial infarction with or without ST segment elevation) or acute attack of heart failure (systolic or diastolic)
- Able to communicate in French and/or helping to communicate in French
- Return home after hospitalization
Health professional
- Voluntary and available for the entire interview
- Having participated in the management of the patient screened on the day of the consultation
- Cardiologist, intern or emergency department nurse
- Attached to the participating service
Exclusion Criteria:
- Patient
- Short-term vital prognosis
- Severe dementia
- Inability to manage drug treatment alone
- Institutionalization at the end of hospitalization
Health professional
- Health professional working in the department only one or two days a week
- Health professional who is not specialized in diseases of interest
| Contact: Anne-Marie SCHOTT, PhD | 4 26 68 82 41 ext 33 | anne-marie.schott-pethelaz@chu-lyon.fr | |
| Contact: Adèle PERRIN | 4 26 68 82 22 ext 33 | adele.perrin@univ-lyon1.fr |
| Principal Investigator: | Anne-Marie SCHOTT, PhD | Hospices Civils de Lyon | |
| Study Chair: | Julie HAESEBAERT, MD | Hospices Civils de Lyon |
| Tracking Information | |||||||
|---|---|---|---|---|---|---|---|
| First Submitted Date | May 10, 2019 | ||||||
| First Posted Date | May 14, 2019 | ||||||
| Last Update Posted Date | May 14, 2019 | ||||||
| Estimated Study Start Date | June 1, 2019 | ||||||
| Estimated Primary Completion Date | July 1, 2019 (Final data collection date for primary outcome measure) | ||||||
| Current Primary Outcome Measures |
Brief Health Literacy Screening (BHLS) of patients hospitalized for a cardiovascular disease. [ Time Frame: Day 1 ] Health literacy will be measured thanks to the questionnaire Brief Health Literacy Screening (BHLS). This questionnaire is composed of 3 questions and is known to screen quickly patient health literacy. The 3 responses are summed to generate a score between 3 and 15, where higher scores indicated higher health literacy. Low health literacy is defined as Brief Health Literacy Screen less than or equal to a score of 9.
|
||||||
| Original Primary Outcome Measures | Same as current | ||||||
| Change History | No Changes Posted | ||||||
| Current Secondary Outcome Measures |
Health Literacy Questionnaire (HLQ) [ Time Frame: Day 1 ] The HLQ explores more dimensions of health literacy such as social support relationship with caregivers, health information evaluation or ability to engage with caregivers. It consists of 44 items. Participants are asked to rate "How strongly do you disagree or agree with the following statements?". The options provided were: 'strongly disagree', 'disagree', 'agree' and 'strongly agree', which were scored from 1 to 4, respectively. In 2nd part of the HLQ, participants were asked "How easy or difficult are the following tasks for you to do now?" The options for these scales were 'cannot do', 'very difficult', 'quite difficult', 'quite easy' and 'very easy', which were scored from 1 to 5, respectively. The higher the score the higher the health literacy of a patient.
|
||||||
| Original Secondary Outcome Measures | Same as current | ||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||
| Descriptive Information | |||||||
| Brief Title | Pilot Study of ILIADE : Exploring Health Literacy Within Patients Hospitalized for Acute Cardiovascular Events | ||||||
| Official Title | Pilot Study of ILIADE: Exploring Health Literacy Within Patients Hospitalized for Acute Cardiovascular Events | ||||||
| Brief Summary |
Health literacy (HL) 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 is known as a health determinant. An association has been shown between low health literacy and low health outcomes such as increased number of unscheduled hospitalization 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 many scientific international literature about health literacy and health outcomes, no information is available in France on the prevalence of low health literacy level of patients, notably cardiovascular patients. The investigating team's hypothesis is that knowing the prevalence of low HL levels in cardiovascular patients would help to better tailored a communication intervention dedicated to the needs of these low-HL patients with the final aim of increasing their adhesion to preventive drugs and behavioural recommendations. The first aim of the present study is to estimate the prevalence of low HL level among patients discharged after acute myocardial infarction or acute decompensation of chronic heart failure. Secondary aims are to assess factors associated with the level of HL and identify barriers and facilitators of low HL patients to understand medical information on their disease. The results of this study will guide the design of the intervention of an interventional study on HL of cardiovascular patients. |
||||||
| 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 patients hospitalized for Acute myocardial infarction (AMI) and acute decompensation of chronic heart failure (CHF) will be screened for one month in the cardiology departments of the Louis Pradel Hospital. | ||||||
| Condition |
|
||||||
| Intervention | Other: Exploring health literacy levels and patients' informal needs or individual relationship between caregivers and patients.
It is a cross-sectional study coupled with a qualitative ancillary study conducted within patients hospitalized for one of the two acute cardiovascular diseases (acute coronary syndrome or acute heart failure). All patients hospitalized at Hospices Civils de Lyon for one of these two diseases and whom are going back home will be enrolled. Few patients will be interviewed during the follow-up visit at 1-month post hospitalisation. Caregivers from cardiology units will also be interviewed.
|
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| Study Groups/Cohorts | Eligible patients
All eligible patients discharged from hospital for Acute Myocardial Infarction (AMI) or acute decompensation of Chronic Heart Failure (CHF)
Intervention: Other: Exploring health literacy levels and patients' informal needs or individual relationship between caregivers and patients.
|
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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 |
100 | ||||||
| Original Estimated Enrollment | Same as current | ||||||
| Estimated Study Completion Date | August 1, 2019 | ||||||
| Estimated Primary Completion Date | July 1, 2019 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria |
Inclusion Criteria: - Patient
Health professional
Exclusion Criteria: - Patient
Health professional
|
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| Sex/Gender |
|
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| Ages | 18 Years and older (Adult, Older Adult) | ||||||
| Accepts Healthy Volunteers | No | ||||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||||
| Listed Location Countries | Not Provided | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number | NCT03949309 | ||||||
| Other Study ID Numbers | 69HCL19_0207 2019-A00799-48 ( Other Identifier: ID-RCB ) |
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| 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 |
|
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| PRS Account | Hospices Civils de Lyon | ||||||
| Verification Date | May 2019 | ||||||
