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Trial details
Impact of Health Literacy on Multiple Patient Variables: A Single-Center Observational Study in Lebanon
Current status:
Approved
|
Date registered:
19/09/2023
Trial version(s)
History: 14/06/2023
Current: 14/06/2023
Click here to view the tips and fields' descriptions
Main Information
Primary registry identifying number
LBCTR2023065377
Protocol number
N/A
MOH registration number
Trial already registered with the MoPH
Study registered at the country of origin
Type of registration
Prospective
Date of registration in national regulatory agency
14/06/2023
Primary sponsor
No sponsor
Primary sponsor: Country of origin
No sponsor
Public title
Impact of Health Literacy on Multiple Patient Variables: A Single-Center Observational Study in Lebanon
Acronym
Scientific title
Impact of Health Literacy on Multiple Patient Variables: A Single-Center Observational Study in Lebanon
Acronym
Brief summary of the study: English
The aim of this study is to assess health literacy among patients receiving care at Lebanese American University Medical Center - Rizk Hospital and to investigate its impact on several patient outcomes. Health literacy refers to an individual’s capacity to obtain, understand, evaluate and apply health information and services in order to make informed decisions about their own healthcare. Poor health literacy is being increasingly recognized in the medical literature as a predictor of health-related outcomes such as more frequent use of emergency care and hospitalizations, adverse drug events and medication errors, inadequate knowledge of antibiotic use and antibiotic resistance resulting in misuse, and poorer quality of life; making it a major public health matter. Research on this topic in Lebanon has only just started to emerge with only two studies having assessed and published results on health literacy in Lebanese samples. None of those studies, however, explored health literacy’s effect on health-related outcomes. As such, this cross-sectional study seeks not only to report the level of health literacy in our patient population, but also to evaluate its effect on the following patient outcomes: quality of life, increased need for health services, adverse drug events, antibiotic misuse, and adequacy of antibiotic knowledge. Data was collected via face-to-face interviews using a questionnaire. These findings will help improve and tailor our patient education practices to target inadequacies in the health literacy of our patient population.
Brief summary of the study: Arabic
الهدف من هذه الدراسة هو تقييم مستوى التنوّر الصحي (أو الثقافة الصحيّة) لدى المرضى المستفيدين من خدمات المركز الطبي للجامعة اللبنانية الأمريكية - مستشفى رزق، وتقدير تأثيره على النتائج المتعلقة بسلامة وصحة هؤلاء المرضى. يُقصد بالتنوّر الصحي قدرة الفرد على الحصول على المعلومات والخدمات الصحية وفهمها وتقييمها وتطبيقها لاتخاذ قرارات بشأن صحته وعلاجه. تشير الدراسات إلى أن التنوّر الصحي المنخفض يعكس نتائج صحية سلبية مثل الحاجة المتكررة لخدمات الطوارئ والاستشفاء، والآثار الجانبية للأدوية والأخطاء الدوائية، والمعرفة الضعيفة بالمضادات الحيوية مما يؤدي إلى سوء استخدامها، وتدني وجودة الحياة. بدأت البحوث حول هذا الموضوع في لبنان حيث قامت دراستان بتقييم ونشر النتائج حول التنوّر الصحي لدى المرضى اللبنانيين. ومع ذلك، لم تدرس أي من تلك الدراسات تأثير التنوّر الصحي على النتائج الصحية. لذلك، تهدف هذه الدراسة إلى الإبلاغ عن مستوى التثقيف الصحي في عينة المرضى لدينا، كذلك تسعى إلى تقييم تأثيرها على النتائج التالية للمرضى: جودة الحياة، زيادة الحاجة للخدمات الصحية، الأحداث والأخطاء الدوائية، سوء استخدام المضادات الحيوية، ومستوى المعرفة بالمضادات الحيوية. تم جمع المعلومات من خلال مقابلات مع المرضى. ستساعد نتائج هذا المشروع في تحسين ممارسات تثقيف المرضى لوتكييفها لاستهداف أوجه القصور في مستوى الثقافة الصحية لمرضانا.
Health conditions/problem studied: Specify
No specific health condition or problem was set as inclusion criteria (included were noncritically ill inpatients at LAUMC-RH)
Interventions: Specify
No intervention was performed. A face-to-face interview was conducted using a questionnaire.
Key inclusion and exclusion criteria: Inclusion criteria
-Aged 18 years or older -Provided informed consent
Key inclusion and exclusion criteria: Gender
Both
Key inclusion and exclusion criteria: Age minimum
18
Key inclusion and exclusion criteria: Age maximum
100
Key inclusion and exclusion criteria: Exclusion criteria
-Has cognitive impairment or an altered mental status at the time of the study -Is critically ill -Does not speak Arabic or English
Type of Study
Type
Observational
Study model
Other
Study model: Specify model
Cross-sectional
Study model: Explain model
Single-center observational cross-sectional study. The subjects were recruited from the inpatient settings at LAUMC-RH. Patients staying at the hospital were approached and screened for eligibility, after which data of interest will be collected through face-to-face interviews using a questionnaire. Informed consent will be sought prior to conducting the interview and after explaining the purpose of the study and stating that all data will be treated confidentially and that withdrawal from the study would be possible at any time. Two copies of the informed consent form will be handed to the patient stating the purpose of the study and providing the contact information of the principal investigators and the LAU institutional review board (IRB) office. One copy is to be signed and returned to the interviewer and another is to remain with the participant for future reference.
Time perspective
Prospective
Time perspective: Explain time perspective
The study took place from November till May.
Target follow-up duration
0
Target follow-up duration: Unit
N/A
Number of groups/cohorts
1
Biospecimen retention
None retained
Biospecimen description
N/A
Target sample size
100
Actual enrollment target size
135
Date of first enrollment: Type
Actual
Date of first enrollment: Date
15/11/2022
Date of study closure: Type
Actual
Date of study closure: Date
31/05/2023
Recruitment status
Complete
Date of completion
31/05/2023
IPD sharing statement plan
No
IPD sharing statement description
N/A
Additional data URL
Summary Results
Secondary Identifying Numbers
Full name of issuing authority
Secondary identifying number
Sources of Monetary or Material Support
Name
Secondary Sponsors
Name
Contact for Public/Scientific Queries
Contact type
First name
Last name
Address
Country
Telephone
Email
Affiliation
Public
Katia
El Harake
Ashrafiyeh, Beirut
Lebanon
76700599
katia.elharake@lau.edu
Lebanese American University - LAUMC-RH
Scientific
Hanine
Mansour
Blat, Byblos
Lebanon
76731512
hanine.mansour@lau.edu.lb
Lebanese American University
Centers/Hospitals Involved in the Study
Center/Hospital name
Name of principles investigator
Principles investigator speciality
Ethical approval
Lebanese American University Medical Center - Rizk Hospital
Katia El Harake, Hanine Mansour, Soumana Nasser, Elsy Ramia
Pharmacists
Approved
Ethics Review
Ethics approval obtained
Approval date
Contact name
Contact email
Contact phone
Lebanese American University- University Medical Center Rizk Hospital
14/09/2022
Joseph Stephan
irb@lau.edu.lb
01786456 ext. (2546)
Countries of Recruitment
Name
Lebanon
Health Conditions or Problems Studied
Condition
Code
Keyword
Interventions
Intervention
Description
Keyword
Primary Outcomes
Name
Time points
Measure
Health literacy level
At time of interview
European Health Literacy Survey Questionnaire—modified short version “HLS-EU-Q16”
Key Secondary Outcomes
Name
Time points
Measure
Quality of life
At time of interview
EQ-5D-5L questionnaire
Antibiotic consumption practices and knowledge about antibiotics
At time of interview
Questions adapted from the WHO validated antibiotic resistance: multi-country public awareness survey
Health services used in the previous year
At time of interview
Number of doctor visits, hospital admissions, emergency department visits per patient report
Adverse drug events in the previous year
At time of interview
Number of adverse drug events per patient report
Trial Results
Summary results in Lebanon
Study results globally
Date of posting of results summaries
Date of first journal publication of results
Results URL link
Baseline characteristics
Participant flow
Adverse events
Outcome measures
URL to protocol files
Link(s) to publications related to the study
Changes History
Change
Date
Download as PDF
Save a PDF copy of the summary of the trial