Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06422598
Status:
RECRUITING
Last Update Posted:
2024-05-21
First Post:
2024-05-15
Brief Title:
Prevalence and Management Practice of Diabetic Kidney Disease at BADAS Affiliated Healthcare Centres in Bangladesh
Sponsor:
Bangladesh Institute of Research and Rehabilitation in Diabetes Endocrine and Metabolic Disorders
Organization:
Bangladesh Institute of Research and Rehabilitation in Diabetes Endocrine and Metabolic Disorders
Study Overview
Official Title:
Prevalence and Management Practice of Diabetic Kidney Disease at BADAS Affiliated Healthcare Centres in Bangladesh - An Exploratory Cross-Sectional Study
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BADAS
Brief Summary:
Background Diabetes is a growing public health concern in Bangladesh with millions affected Diabetic Kidney Disease DKD is a severe complication of diabetes affecting approximately 213 of the diabetic population To address this issue a comprehensive assessment of DKD within the Bangladesh Diabetic Association39s BADAS affiliated healthcare centres is necessary
Objective The study39s general objective is to determine the prevalence of DKD and evaluate its management at BADAS-affiliated healthcare centers Specific objectives include assessing risk factors screening practices disease staging management approaches patient education and providing evidence-based recommendations
Methodology
Study Design Cross-sectional
Study Population All diabetic patients at BADAS-affiliated centers
Exclusion Criteria Patients unwilling to participate or with kidney disease from other causes and with acute illness
Sample Size 34Forty patients will be selected from each center resulting in a total sample size of 320 patients across eight centers with one center randomly selected from each of the eight divisions in Bangladesh34
Data Collection Demographics comorbidities kidney function blood pressure HbA1c levels medication records treatment guideline adherence
Data Analysis prevalence of diabetic kidney disease factors affecting management and potential barriers
Ethical Considerations Ensure patient data privacy obtain approvals and informed consent Implications The study aims to provide insights into the current state of magnitude prevalence of DKD its management highlighting areas for improvement in patient care guideline adherence and ultimately enhancing the well-being of diabetic patients in Bangladesh
Objective The study39s general objective is to determine the prevalence of DKD and evaluate its management at BADAS-affiliated healthcare centers Specific objectives include assessing risk factors screening practices disease staging management approaches patient education and providing evidence-based recommendations
Methodology
Study Design Cross-sectional
Study Population All diabetic patients at BADAS-affiliated centers
Exclusion Criteria Patients unwilling to participate or with kidney disease from other causes and with acute illness
Sample Size 34Forty patients will be selected from each center resulting in a total sample size of 320 patients across eight centers with one center randomly selected from each of the eight divisions in Bangladesh34
Data Collection Demographics comorbidities kidney function blood pressure HbA1c levels medication records treatment guideline adherence
Data Analysis prevalence of diabetic kidney disease factors affecting management and potential barriers
Ethical Considerations Ensure patient data privacy obtain approvals and informed consent Implications The study aims to provide insights into the current state of magnitude prevalence of DKD its management highlighting areas for improvement in patient care guideline adherence and ultimately enhancing the well-being of diabetic patients in Bangladesh
Detailed Description:
Background Diabetes mellitus represents a significant public health challenge globally and Bangladesh is no exception to this growing epidemic According to the International Diabetes Federation IDF about 131 million people in Bangladesh have diabetes and this number is expected to increase to 223 million by 2045Sun et al 2022 One of the most serious complications of diabetes is Diabetic Kidney Disease DKD which can lead to chronic kidney disease and end-stage renal disease ESRD DKD not only imposes a heavy burden on the healthcare system but also affects the economic and social well-being of the patients and their families The prevalence of kidney disease among the diabetic population of Bangladesh is estimated to be around 213 This number is based on a single center study conducted at the Bangladesh Institute of Health Sciences BIHS hospital in Dhaka BangladeshIslam et al 2021 This high prevalence highlights the need for a comprehensive evaluation of DKD within the centers affiliated with the Bangladesh diabetic association BADAS which is the largest non-governmental organization providing diabetes care and research in the country
The Bangladesh Diabetic Association BADAS with its extensive network of diabetes care centers and healthcare professionals has long been at the forefront of addressing diabetes-related health concerns in the country As a nation-wide institution dedicated to diabetes care BADAS plays a pivotal role in delivering healthcare services and shaping the well-being of diabetic patients in Bangladesh
A comprehensive understanding of DKD prevalence and management status within BADAS centers is essential to enhance the quality of care for diabetic patients Identifying areas for improvement is the first step towards effecting positive change
Our ultimate plan is to implement a nationwide DKD prevention program through affiliated diabetic centers To achieve this a comprehensive assessment of the current situation is an imperative foundation for program design planning and execution
The study will provide a rich dataset upon which evidence-based recommendations for preventing and managing DKD within BADAS-affiliated centers can be developed These recommendations are essential for improving patient outcomes and ensuring the success of the future prevention program
In conclusion the proposed study is a crucial undertaking aimed at addressing the pressing issue of DKD within the context of BADAS-affiliated healthcare centers It serves as the first step towards the larger goal of implementing a nationwide DKD prevention program with the potential to positively impact the health and well-being of diabetic patients across Bangladesh
Objective
General Objective
To determine the prevalence of diabetic kidney disease and assess the management status of diabetic kidney disease in patients attending affiliated healthcare centers of the Bangladesh Diabetic Associations
Specific Objectives
Determine the Prevalence of Diabetic Kidney Disease Calculate the prevalence of DKD among diabetic patients visiting BADAS-affiliated healthcare centers using clinical and laboratory assessments
Assess Risk Factors for DKD Identify and analyze demographic and clinical factors associated with the development of DKD in the study population
Evaluate Screening Practices Evaluate the extent to which BADAS-affiliated healthcare centers conduct regular screening of registered diabetic patients for DKD and assess the effectiveness of current screening protocols
Characterize Disease Staging Determine the stages of DKD among patients diagnosed with the condition and assess the proportion of patients with various stages of renal impairment
Analyze Management Approaches Investigate the treatment modalities including pharmacological interventions lifestyle modifications and patient education used to manage DKD in the healthcare centers
Assess Healthcare Professional Awareness Evaluate the awareness and knowledge of healthcare professionals working in BADAS-affiliated centres regarding DKD prevention diagnosis and management
Assess the infrastructural support of BADAS-affiliated centres regarding DKD prevention diagnosis and management
Examine Patient Education and Engagement Assess the level of patient education and engagement in DKD management programs including lifestyle modification guidance and adherence to treatment plans
Provide Recommendations Based on the study findings generate evidence-based recommendations for improving the prevention early detection and management of DKD in BADAS-affiliated healthcare centers to enhance the quality of care for diabetic patients
Material and Methodology
Study Design
Cross-sectional study design
Study Population
All registered diabetic patients receiving care at affiliated healthcare centres of Bangladesh Diabetic Associations
Exclusion criteria
Unwilling to participate in the study Presence of AKI or acute illness Presence of Known kidney disease due to other cause
Sampling method Multi-stage sampling
Sample size calculation
The formula to calculate the sample size
Where
n required sample size Z Z-score corresponding to the desired confidence level eg 196 for a 95 confidence level p expected prevalence in decimal form E margin of error in decimal form Expected prevalence of DKD to be 213 0213 in decimal form Confidence level 95 Margin of error of 5 005 in decimal form
Using these values the sample size calculation would look like this
292 However we will select forty patients from each centre resulting in a total sample size of 320 patients across eight centres with one centre will be randomly selected from each of the eight divisions in Bangladesh
Data Collection
Gather patient data including demographics comorbidities kidney function eGFR UACR blood pressure measurements and HbA1c levels
Review medication records to determine the use of anti-proteinuric medications eg ACE inhibitors angiotensin receptor blockers SGLT2i nonsteroidal mineralocorticoids receptor antagonists and GLP analogues
Assess adherence to recommended treatment guidelines for diabetic kidney disease management
Collect data on healthcare professionals39 awareness and knowledge of DKD prevention diagnosis and management
Gather data on the infrastructure available in BADAS-affiliated centres for DKD prevention diagnosis and management
Screening for the presence of DKD
The diagnostic criteria for diabetic kidney disease DKDMcGrath and Edi 2019 ElSayed et al 2022
DKD is usually a clinical diagnosis in a patient with long-standing diabetes gt10 years with albuminuria andor reduced eGFR in the absence of signs or symptoms of other primary causes of kidney damage
Albuminuria Increased urinary albumin excretion is defined as 30 mgg 2 out of 3 in 3 to 6 months
Reduced estimated Glomerular Filtration Rate eGFR lt60mlminute173m2 for more than 3 months Duration of Diabetes DKD is typically associated with a long duration of diabetes gt10 years duration of type 1 diabetes may be present at diagnosis in type 2 diabetes
Presence of Retinopathy DKD is typically associated with retinopathy however the absence of retinopathy does not exclude DKD in type 2 diabetes
Data Analysis
Evaluate the proportion of patients achieving target blood pressure control eg lt13080 mm Hg glycaemic control eg HbA1c lt7 and receiving appropriate anti-proteinuric medications
Examine factors associated with successful management including age gender duration of diabetes and comorbidities
Identify potential barriers to achieving optimal management
Ethical Considerations
Ensure patient data privacy and confidentiality Obtain necessary approvals and informed consent for data access and analysis
Implications
Provide insights into the current magnitude and state of diabetic kidney disease management specifically focusing on blood pressure and glycaemic control and the utilization of anti-proteinuric medications among diabetic patients
Highlight areas for improvement in patient care and guideline adherence to enhance diabetic kidney disease management
The Bangladesh Diabetic Association BADAS with its extensive network of diabetes care centers and healthcare professionals has long been at the forefront of addressing diabetes-related health concerns in the country As a nation-wide institution dedicated to diabetes care BADAS plays a pivotal role in delivering healthcare services and shaping the well-being of diabetic patients in Bangladesh
A comprehensive understanding of DKD prevalence and management status within BADAS centers is essential to enhance the quality of care for diabetic patients Identifying areas for improvement is the first step towards effecting positive change
Our ultimate plan is to implement a nationwide DKD prevention program through affiliated diabetic centers To achieve this a comprehensive assessment of the current situation is an imperative foundation for program design planning and execution
The study will provide a rich dataset upon which evidence-based recommendations for preventing and managing DKD within BADAS-affiliated centers can be developed These recommendations are essential for improving patient outcomes and ensuring the success of the future prevention program
In conclusion the proposed study is a crucial undertaking aimed at addressing the pressing issue of DKD within the context of BADAS-affiliated healthcare centers It serves as the first step towards the larger goal of implementing a nationwide DKD prevention program with the potential to positively impact the health and well-being of diabetic patients across Bangladesh
Objective
General Objective
To determine the prevalence of diabetic kidney disease and assess the management status of diabetic kidney disease in patients attending affiliated healthcare centers of the Bangladesh Diabetic Associations
Specific Objectives
Determine the Prevalence of Diabetic Kidney Disease Calculate the prevalence of DKD among diabetic patients visiting BADAS-affiliated healthcare centers using clinical and laboratory assessments
Assess Risk Factors for DKD Identify and analyze demographic and clinical factors associated with the development of DKD in the study population
Evaluate Screening Practices Evaluate the extent to which BADAS-affiliated healthcare centers conduct regular screening of registered diabetic patients for DKD and assess the effectiveness of current screening protocols
Characterize Disease Staging Determine the stages of DKD among patients diagnosed with the condition and assess the proportion of patients with various stages of renal impairment
Analyze Management Approaches Investigate the treatment modalities including pharmacological interventions lifestyle modifications and patient education used to manage DKD in the healthcare centers
Assess Healthcare Professional Awareness Evaluate the awareness and knowledge of healthcare professionals working in BADAS-affiliated centres regarding DKD prevention diagnosis and management
Assess the infrastructural support of BADAS-affiliated centres regarding DKD prevention diagnosis and management
Examine Patient Education and Engagement Assess the level of patient education and engagement in DKD management programs including lifestyle modification guidance and adherence to treatment plans
Provide Recommendations Based on the study findings generate evidence-based recommendations for improving the prevention early detection and management of DKD in BADAS-affiliated healthcare centers to enhance the quality of care for diabetic patients
Material and Methodology
Study Design
Cross-sectional study design
Study Population
All registered diabetic patients receiving care at affiliated healthcare centres of Bangladesh Diabetic Associations
Exclusion criteria
Unwilling to participate in the study Presence of AKI or acute illness Presence of Known kidney disease due to other cause
Sampling method Multi-stage sampling
Sample size calculation
The formula to calculate the sample size
Where
n required sample size Z Z-score corresponding to the desired confidence level eg 196 for a 95 confidence level p expected prevalence in decimal form E margin of error in decimal form Expected prevalence of DKD to be 213 0213 in decimal form Confidence level 95 Margin of error of 5 005 in decimal form
Using these values the sample size calculation would look like this
292 However we will select forty patients from each centre resulting in a total sample size of 320 patients across eight centres with one centre will be randomly selected from each of the eight divisions in Bangladesh
Data Collection
Gather patient data including demographics comorbidities kidney function eGFR UACR blood pressure measurements and HbA1c levels
Review medication records to determine the use of anti-proteinuric medications eg ACE inhibitors angiotensin receptor blockers SGLT2i nonsteroidal mineralocorticoids receptor antagonists and GLP analogues
Assess adherence to recommended treatment guidelines for diabetic kidney disease management
Collect data on healthcare professionals39 awareness and knowledge of DKD prevention diagnosis and management
Gather data on the infrastructure available in BADAS-affiliated centres for DKD prevention diagnosis and management
Screening for the presence of DKD
The diagnostic criteria for diabetic kidney disease DKDMcGrath and Edi 2019 ElSayed et al 2022
DKD is usually a clinical diagnosis in a patient with long-standing diabetes gt10 years with albuminuria andor reduced eGFR in the absence of signs or symptoms of other primary causes of kidney damage
Albuminuria Increased urinary albumin excretion is defined as 30 mgg 2 out of 3 in 3 to 6 months
Reduced estimated Glomerular Filtration Rate eGFR lt60mlminute173m2 for more than 3 months Duration of Diabetes DKD is typically associated with a long duration of diabetes gt10 years duration of type 1 diabetes may be present at diagnosis in type 2 diabetes
Presence of Retinopathy DKD is typically associated with retinopathy however the absence of retinopathy does not exclude DKD in type 2 diabetes
Data Analysis
Evaluate the proportion of patients achieving target blood pressure control eg lt13080 mm Hg glycaemic control eg HbA1c lt7 and receiving appropriate anti-proteinuric medications
Examine factors associated with successful management including age gender duration of diabetes and comorbidities
Identify potential barriers to achieving optimal management
Ethical Considerations
Ensure patient data privacy and confidentiality Obtain necessary approvals and informed consent for data access and analysis
Implications
Provide insights into the current magnitude and state of diabetic kidney disease management specifically focusing on blood pressure and glycaemic control and the utilization of anti-proteinuric medications among diabetic patients
Highlight areas for improvement in patient care and guideline adherence to enhance diabetic kidney disease management
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| BADAS-ERCEC2423 | OTHER | The Diabetic Association of Bangladesh BADAS | None |