Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06503068
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-01
Brief Title:
Impact of NAFLD vs MAFLD Stigma on Quality of Life in Egyptian Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
NAFLD Stigma vs MAFLD Stigma and Their Impact on Quality of Life in Egyptian Patients A Survey Study
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Non-alcoholic fatty liver disease NAFLD has become the leading cause of liver disease worldwide The global burden of NAFLD is about 30 of the population With a higher prevalence in Egypt about 475 The prevalence increases significantly with the presence of type 2 diabetes and obesity
NAFLD is commonly associated with metabolic dysfunction and the development of cardiovascular disease However the NAFLD definition excludes other causes It is not correlated with metabolic dysfunction and cardiovascular risk so in 2020 the term metabolic-dysfunction-associated fatty liver disease MAFLD was suggested to replace the term NAFLD
The nomenclature change was partly related to the stigma associated with the term NAFLD As the words alcoholic and fatty were considered stigmatizing A recent global survey showed that 26 of patients 57 in the USA and 7 in MENA felt stigmatized relating to overweightobesity and 8 of patients 22 in the USA and 3 in MENA felt stigmatized by the term NAFLD While 34 and 38 of physicians considered the words non-alcoholic and fatty stigmatizing respectively
There is a discrepancy between the different regions of the world and between patients and providers regarding the perception of NAFLD MAFLD stigma This study aims to assess the perception and stigmatization of various diagnostic terms fatty liver NAFLD MAFLD among Egyptian patients and physicians Also to assess the impact of stigma on the quality of life and the motivations and barriers for lifestyle modification which is the cornerstone of NAFLDMAFLD management
NAFLD is commonly associated with metabolic dysfunction and the development of cardiovascular disease However the NAFLD definition excludes other causes It is not correlated with metabolic dysfunction and cardiovascular risk so in 2020 the term metabolic-dysfunction-associated fatty liver disease MAFLD was suggested to replace the term NAFLD
The nomenclature change was partly related to the stigma associated with the term NAFLD As the words alcoholic and fatty were considered stigmatizing A recent global survey showed that 26 of patients 57 in the USA and 7 in MENA felt stigmatized relating to overweightobesity and 8 of patients 22 in the USA and 3 in MENA felt stigmatized by the term NAFLD While 34 and 38 of physicians considered the words non-alcoholic and fatty stigmatizing respectively
There is a discrepancy between the different regions of the world and between patients and providers regarding the perception of NAFLD MAFLD stigma This study aims to assess the perception and stigmatization of various diagnostic terms fatty liver NAFLD MAFLD among Egyptian patients and physicians Also to assess the impact of stigma on the quality of life and the motivations and barriers for lifestyle modification which is the cornerstone of NAFLDMAFLD management
Detailed Description:
This cross-sectional study will be carried out in collaboration between the Tropical Medicine Department and Public Health Department Tanta University Hospitals A questionnaire in both digital and written forms targeting patients with NAFLDNASH and physicians treating NAFLDNASH patients in Egypt
Type of study
Prospective cross-sectional survey
Duration of study
Study will be carried out from May 2024 to August 2024 or until the target number is reached about 500 subjects
Target subjects
The questionnaire will target a convenience sample of NAFLDNASH patients and physicians treating NAFLDNASH patients about 500 subjects
The questionnaire will be written and digital in both Arabic and English versions
Methodology
After designing the questionnaire it will be discussed with other experts in the field validity and reliability will be assessed and a pilot study will be done
After an informed consent subject will answer a designed questionnaire either written or digital 2 phases will be done The questionnaire will be divided into 3 sectors Sector 1 Demographic data questions about age sex residence educational level occupation subspecialty workplace for all participants
Sector 2 Socioeconomic level determination mainly for population Socio-economic data will be gathered through questions asking about the number of family members number of rooms in the apartment level of education occupation and cost per month
Sector 3 the main work includes questions for patients patient awareness of NAFLD before diagnosis presence and severity of liver fibrosis presence of comorbidities the diagnostic term they use to describe their disease have they disclosed their condition to family or friends have they experienced stigmatization or discriminations due to their disease and how frequently how they feel about the words fatty alcoholic and metabolic have they avoided or missed a visit with their physician due to NAFLD patients concerns about the disease and its progression barriers and motivations for lifestyle modifications
For physicians their clinical experience in NAFLD and the number of NAFLDNASH patients they see per month what terms they think are considered stigmatizing to their patients fatty non-alcoholic overweightobese metabolic associated does their patients feel discrimination due to their disease would the name change help their patients causes of frustration and discomfort when treating NAFLD patients their opinion of what are the barriers and motivations for lifestyle modifications in their patients
Ethical considerations
A written or digital informed consent form authorizing the collection of this data was signed by all subjects The study will be approved by the Ethical Committee of Faculty of Medicine Tanta University
The risks to the participants and measures needed to minimize these risks
The privacy of the data of the patients will be maintained
Any unexpected risks appear during the course of research will be cleared to the subjects and the ethical committee on time
Adequate provisions to maintain the privacy of participants and confidentially of data are as follows
A code number for each patient will be used and symbols for the name and address will be kept in a special file
The investigators will hide the patients names when the research is used
The investigators will use the results of the research only for scientific aims and not use it in other aims
The endpoint of this study
Assess the prevalence of NAFLDMAFLD stigma among both patients and physicians and the beneficence of name change from NAFLD to MAFLD in Egypt to determine the factors leading to lifestyle modifications in NAFLDMAFLD patients thus improving patients quality of life
Type of study
Prospective cross-sectional survey
Duration of study
Study will be carried out from May 2024 to August 2024 or until the target number is reached about 500 subjects
Target subjects
The questionnaire will target a convenience sample of NAFLDNASH patients and physicians treating NAFLDNASH patients about 500 subjects
The questionnaire will be written and digital in both Arabic and English versions
Methodology
After designing the questionnaire it will be discussed with other experts in the field validity and reliability will be assessed and a pilot study will be done
After an informed consent subject will answer a designed questionnaire either written or digital 2 phases will be done The questionnaire will be divided into 3 sectors Sector 1 Demographic data questions about age sex residence educational level occupation subspecialty workplace for all participants
Sector 2 Socioeconomic level determination mainly for population Socio-economic data will be gathered through questions asking about the number of family members number of rooms in the apartment level of education occupation and cost per month
Sector 3 the main work includes questions for patients patient awareness of NAFLD before diagnosis presence and severity of liver fibrosis presence of comorbidities the diagnostic term they use to describe their disease have they disclosed their condition to family or friends have they experienced stigmatization or discriminations due to their disease and how frequently how they feel about the words fatty alcoholic and metabolic have they avoided or missed a visit with their physician due to NAFLD patients concerns about the disease and its progression barriers and motivations for lifestyle modifications
For physicians their clinical experience in NAFLD and the number of NAFLDNASH patients they see per month what terms they think are considered stigmatizing to their patients fatty non-alcoholic overweightobese metabolic associated does their patients feel discrimination due to their disease would the name change help their patients causes of frustration and discomfort when treating NAFLD patients their opinion of what are the barriers and motivations for lifestyle modifications in their patients
Ethical considerations
A written or digital informed consent form authorizing the collection of this data was signed by all subjects The study will be approved by the Ethical Committee of Faculty of Medicine Tanta University
The risks to the participants and measures needed to minimize these risks
The privacy of the data of the patients will be maintained
Any unexpected risks appear during the course of research will be cleared to the subjects and the ethical committee on time
Adequate provisions to maintain the privacy of participants and confidentially of data are as follows
A code number for each patient will be used and symbols for the name and address will be kept in a special file
The investigators will hide the patients names when the research is used
The investigators will use the results of the research only for scientific aims and not use it in other aims
The endpoint of this study
Assess the prevalence of NAFLDMAFLD stigma among both patients and physicians and the beneficence of name change from NAFLD to MAFLD in Egypt to determine the factors leading to lifestyle modifications in NAFLDMAFLD patients thus improving patients quality of life
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None