| CTRI Number |
CTRI/2023/12/060720 [Registered on: 26/12/2023] Trial Registered Prospectively |
| Last Modified On: |
01/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Translation of the Diabetes Distress Scale (DDS) into Gujarati and Validation of the Translation |
|
Scientific Title of Study
|
Translation of Diabetes Distress Scale (DDS) in Gujarati Version and its Validation |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Richa Manjani |
| Designation |
1st year MPT student |
| Affiliation |
College Of Physiotherapy Sumandeep Vidyapeeth deemed to be University |
| Address |
College of physiotherapy, Sumandeep Vidyapeeth deemed to be University ,Piparia, Waghodia.
Vadodara
GUJARAT
391760
India |
| Phone |
6352673940 |
| Fax |
|
| Email |
richapmanjani2001@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Richa Manjani |
| Designation |
Associate Professor. |
| Affiliation |
College Of Physiotherapy Sumandeep Vidyapeeth deemed to be University. |
| Address |
College of physiotherapy, Sumandeep Vidyapeeth deemed to be University ,Piparia, Waghodia.
College of physiotherapy, Sumandeep Vidyapeeth deemed to be University ,Piparia, Waghodia.
Vadodara
GUJARAT
391760
India |
| Phone |
06352673940 |
| Fax |
|
| Email |
richapmanjani2001@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rushikesh Joshi |
| Designation |
Associate Professor. |
| Affiliation |
College Of Physiotherapy Sumandeep Vidyapeeth deemed to be University. |
| Address |
College of physiotherapy, Sumandeep Vidyapeeth deemed to be University ,Piparia, Waghodia.
GUJARAT
391760
India |
| Phone |
8141633941 |
| Fax |
|
| Email |
drrushikesh.cop@sumandeepvidyapeethdu.edu.in |
|
|
Source of Monetary or Material Support
|
| This is self-funded study. The infrastructure is provided by college of physiotherapy, Sumandeep Vidyapeeth, An institutional Deemed to be university. |
|
|
Primary Sponsor
|
| Name |
Richa Prakashkumar Manjani |
| Address |
College of physiotherapy, Sumandeep Vidyapeeth deemed to be University ,Piparia, Waghodia. |
| Type of Sponsor |
Other [self funded] |
|
|
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 |
| Richa Manjani |
Dheeraj Hospital |
DGH (Dheeraj General Hospital) from old and new building Piparia, Waghodia, vadodara.
Vadodara
GUJARAT |
6352673940
richapmanjani2001@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| constituent institutes of Sumandeep Vidyapeeth |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
participate can be Male and Female diagnosed with Type2 Diabetes at least one year ago with Age Group 25 to 80. Who can read, write and understand Gujarati. |
|
| ExclusionCriteria |
| Details |
participate diagnosed with any cognitive and chronic disases. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Diabetes Distress Scale |
10 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="134"
Sample Size from India="134"
Final Enrollment numbers achieved (Total)= "134"
Final Enrollment numbers achieved (India)="134" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/01/2024 |
| Date of Study Completion (India) |
31/03/2025 |
| Date of First Enrollment (Global) |
01/02/2025 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
The Diabetes Distress Scale translated in Gujarati language by four different translator according to the standard guidelines cross-cultural adaption of self-report measures. then the participants selected as per the inclusive and exclusive criteria from Dheeraj Hospital. before taking part all informed about the study procedure. those who are willing to participate in the study, will be requested to fill the informed consent form and then the Gujarati version of Diabetes Distress Scale is self-filled by participant. |