| 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
|
|
|
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
|
|
|
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. |