| CTRI Number |
CTRI/2024/08/071891 [Registered on: 05/08/2024] Trial Registered Prospectively |
| Last Modified On: |
31/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to understand the knowledge about Type 2 Diabetes among Indian diabetic patients |
|
Scientific Title of Study
|
A cross- sectional study to assess the awareness and knowledge about Diabetes mellitus and its risk factors among Indian diabetic patients |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pramod Tripathi |
| Designation |
Director |
| Affiliation |
Freedom From Diabetes Research Foundation |
| Address |
Freedom From Diabetes Research Foundation, Parth, Ghodke Chowk, Prabhat Road, Pune, Maharashtra, India - 411004
Pune
MAHARASHTRA
411004
India |
| Phone |
07776077760 |
| Fax |
|
| Email |
drpramod@freedomfromdiabetes.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nidhi Kadam |
| Designation |
Head of the Department (HoD) |
| Affiliation |
Freedom From Diabetes Research Foundation |
| Address |
Freedom From Diabetes Research Foundation, Parth, Ghodke Chowk, Prabhat Road, Pune, Maharashtra, India - 411004
Pune
MAHARASHTRA
411004
India |
| Phone |
9822792772 |
| Fax |
|
| Email |
research@freedomfromdiabetes.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nidhi Kadam |
| Designation |
Head of the Department (HoD) |
| Affiliation |
Freedom From Diabetes Research Foundation |
| Address |
Freedom From Diabetes Research Foundation, Parth, Ghodke Chowk, Prabhat Road, Pune, Maharashtra, India - 411004
MAHARASHTRA
411004
India |
| Phone |
9822792772 |
| Fax |
|
| Email |
research@freedomfromdiabetes.org |
|
|
Source of Monetary or Material Support
|
| Freedom From Diabetes Research Foundation, Parth, Ghodke Chowk, Prabhat Road, Pune, Mahrashtra - 411004 |
|
|
Primary Sponsor
|
| Name |
Freedom From Diabetes Research Foundation |
| Address |
Parth, Ghodke Chowk, Prabhat Road, Pune, Maharashtra - 411004 |
| Type of Sponsor |
Research institution |
|
|
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 Nidhi Kadam |
Freedom from Diabetes Clinic |
Department of Research, Freedom from Diabetes Research Foundation, Parth, Ghodke Chowk Prabhat Road, Pune,
MAHARASHTRA
Pune
MAHARASHTRA |
9822792772
research@freedomfromdiabetes.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Freedom from Diabetes Research Foundation- Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E08-E13||Diabetes mellitus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients who are 18 - 70 years of age at the time of enrollment
2. Patients who provide written informed consent
|
|
| ExclusionCriteria |
| Details |
1. Patients below 18 or above 70 years of age
2. Patients who do not give consent |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
This study will help to assess knowledge levels of T2D among study participants
|
Cross-sectional single point at baseline only |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| None |
NA |
|
|
Target Sample Size
|
Total Sample Size="370"
Sample Size from India="370"
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)
|
15/08/2024 |
| 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="6"
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
|
Effective management of Type 2 Diabetes entails not only medical interventions but also an understanding of knowledge towards the condition to enable effective healthcare interventions. In this context, this proposed study aims to comprehensively investigate the knowledge levels of T2D in patients providing insights into the understanding, perceptions, and behaviors related to the management of the disease. The study has two objectives: 1. To assess the knowledge about Type 2 Diabetes among participants attending an introductory session for a Diabetes Management Program and 2. To identify challenges and factors influencing knowledge related to T2D management among the participants. Data related to knowledge about T2D will be collected using a validated questionnaire. The questionnaire will be administered online prior to the Discover Reversal Session, and data will be collected via a Google form. In addition to the knowledge data, baseline socio-demographic characteristics such as age, sex, education, socio- economic status, medical history etc. will be collected. Data pertaining to knowledge assessment will be collected using a validated DKQ-Revised (DKQ-R) questionnaire. DKQ-R is a revised version of the DKQ-24 questionnaire. The DKQ-R comprises 22 items on diabetes knowledge and has been established as a reliable and validated tool to measure diabetes knowledge for diverse populations with T2D. This study will help to assess knowledge levels of T2D among study participants and also will aid healthcare providers in understanding and addressing knowledge gaps about T2D and its association with the health status of the participants. |