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CTRI Number  CTRI/2024/07/070937 [Registered on: 22/07/2024] Trial Registered Prospectively
Last Modified On: 19/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   A Survey to Evaluate Diabetes Distress and its Association with Blood Glucose Control and Diabetic Complications 
Scientific Title of Study   Assessment of Diabetes Distress and Its Impact on Glycemic Control and Diabetic Complications: A Cross-Sectional Study  
Trial Acronym  NIL  
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Amna Reem 
Designation  Student 
Affiliation  NGSM Institute of pharmaceutical science 
Address  Department of Pharmacy Practice, NGSM Institute of Pharmaceutical sciences, Paneer, Deralakatte, Mangaluru-575018

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9633979990  
Fax    
Email  amnaareem@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Uday Venkat Mateti 
Designation  Assistant Professor  
Affiliation  NGSM Institute of pharmaceutical science 
Address  Department of Pharmacy Practice, NGSM Institute of Pharmaceutical sciences, Paneer, Deralakatte, Mangaluru-575018

Dakshina Kannada
KARNATAKA
575018
India 
Phone  8152977460  
Fax    
Email  udayv@nitte.edu.in  
 
Details of Contact Person
Public Query
 
Name  Dr Adithi Kellarai 
Designation  Associate Professor  
Affiliation  Justice KS Hegde Charitable Hospital 
Address  Department of General Medicine Justice KS Hegde Charitable Hospital K.S. Hegde Medical Academy Deralakatte, Mangaluru – 575018

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9886517329  
Fax    
Email  adithibhandary@nitte.edu.in  
 
Source of Monetary or Material Support  
Department of General Medicine Justice KS Hegde Charitable Hospital K.S. Hegde Medical Academy Deralakatte, Mangaluru –575018 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [NIL] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Adithi Kellarai  Justice K S Hegde Charitable Hospital   Department of General Medicine, Justice K S Hegde Charitable Hospital K.S. Hegde Medical Academy Deralakatte, Mangaluru – 575018
Dakshina Kannada
KARNATAKA 
9886517329

adithibhandary@nitte.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
NGSM Institute of Pharmaceutical Sciences Institutional Ethics Committee (NGSMIPS-IEC)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E116||Type 2 diabetes mellitus with other specified complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Type 2 Diabetes patients above 18 years of age of either gender who were diagnosed at least 2 years back 
 
ExclusionCriteria 
Details  1) Patients with psychiatric disorders or mental illnesses
2) Critically ill patients
3) Immunocompromised patients
4) Pregnant women  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Various aspects of distress among type 2 diabetes mellitus patients  8 Months  
 
Secondary Outcome  
Outcome  TimePoints 
Diabetes-associated Distress association with glycemic control and diabetes complications among type 2 diabetes patients  8 Months  
 
Target Sample Size   Total Sample Size="354"
Sample Size from India="354" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   30/07/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

INTRODUCTION

Diabetes is a disease that is considered to be difficult for patients to manage given that it incorporates many restricting instructions. Psychological comorbidity, like depression and/or diabetic distress, are prevalent among patients with T2DM and have been linked with less effective outcomes of the treatment Diabetes distress can influence the relationship between depression and glycaemic control.

OBJECTIVE

To translate and validate PAID (Problem areas in diabetes) scale into Kannada and Malayalam languages.

To evaluate the diabetes-associated distress and its association with glycaemic control and diabetes complications among type 2 diabetes patients.

JUSTIFICATION OF THE STUDY

T2DM often results in mental health conditions commonly; depression and diabetes distress. This gives rise to patient’s risk for mortality, poor disease management, diabetes-related complications, and decreased quality of life. Depression and diabetes distress have resulted in poor medication adherence and a decrease in self-care leading to negative outcomes in Type 2 diabetes patients. It has been reported that diabetes patients usually experience depression and anxiety. A meta-analysis reported that about 36% of T2DM experience distress. However, the data on diabetes distress and its association with glycaemic control and diabetic complications among Indian patients are limited which makes it a novel area to be explored.

METHODOLOGY

PAID (Problem areas in diabetes) scale will be translated into Malayalam and Kannada. Patients with a confirmed diagnosis of type 2 Diabetes, who are attending inpatient and outpatient units of Justice K.S Hedge charitable hospital in an age group above 18 years, diagnosed at least 2 years back and willing to participate in the study. A data collection form will be used to collect data, each participant will complete the PAID scale. Diabetic distress was determined using the questionnaire.

STATISTICAL ANALYSIS

The data will be summarised using descriptive statistics, Mean, Standard deviations, Median, Inter Quartile Range, frequency, and percentage. Shapiro-wilk test will be used to evaluate the normality of data. the reliability of the translation will be assessed by Cronbach alpha score, and the validity of the translation will be determined using person correlation/Spearman rank correlation. Inferential statistics will be analysed using Chi-square test, Unpaired t-test/Mann-Whitney U test, Quade’s ANCOVA test, Multiple linear Regression analysis, Univariate regression analysis, Multivariate Logistic Regression Analysis, Odds Ratio

OUTCOME MEASURES

This study will give an overview of various aspects of distress among type 2 diabetes mellitus patients and its associations with glycaemic control and complications.

 
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