| CTRI Number |
CTRI/2024/03/063918 [Registered on: 11/03/2024] Trial Registered Prospectively |
| Last Modified On: |
18/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
The translation and validation of the diabetes self-management questionnaire and its correlation with the prevalence of musculoskeletal disorders in the diabetic population in India |
|
Scientific Title of Study
|
Translation and Validation of Diabetes Self Management Questionnaire and its Association with Prevalence of Musculoskeletal Disorders among Indian Diabetic Population |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bhuvan Mohindra |
| Designation |
Postgraduate Student |
| Affiliation |
Amity Institute of Health and Allied Sciences |
| Address |
Siri Fort Road House no 9 Ground Floor New Delhi 110049
Siri Fort Road House no 9 , Ground Floor New Delhi 110049
South
DELHI
110049
India |
| Phone |
7838893173 |
| Fax |
0 |
| Email |
mohindrabhuvan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rabab Kaur |
| Designation |
Assistant professor |
| Affiliation |
Amity Institute of Health and Allied Sciences |
| Address |
Amity Institute of Health and Allied Sciences , Amity University Noida , Sector 125 , Uttar Pradesh , 201301
Sector 125 , Uttar Pradesh 201301
Gautam Buddha Nagar
UTTAR PRADESH
201301
India |
| Phone |
9654478155 |
| Fax |
|
| Email |
rkaur4@amity.edu |
|
Details of Contact Person
Public Query
|
| Name |
Rabab Kaur |
| Designation |
Assistant professor |
| Affiliation |
Amity Institute of Health and Allied Sciences |
| Address |
Amity Institute of Health and Allied Sciences , Amity University Noida , Sector 125 , Uttar Pradesh , 201301
Sector 125 , Uttar Pradesh 201301
Gautam Buddha Nagar
UTTAR PRADESH
201301
India |
| Phone |
9654478155 |
| Fax |
|
| Email |
rkaur4@amity.edu |
|
|
Source of Monetary or Material Support
|
| Amity University Noida , Sector 125 , Noida , Uttar Pradesh 201301 |
|
|
Primary Sponsor
|
| Name |
Bhuvan Mohindra |
| Address |
Amity University Noida |
| Type of Sponsor |
Other [] |
|
|
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 Zeeshan Ahmad |
New India Physiotherapy And Rehabilitation Centre |
Basement - Supertech Emerald Court Apartments , Sector - 93 A Noida , Uttar Pradesh - 201305
Gautam Buddha Nagar
UTTAR PRADESH |
9911598354
0
ahmad.zee86@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional NTCC Committee Amity Institute of Health Allied Sciences , Amity University Uttar Pradesh |
Approved |
| New India Physiotherapy And Rehabilitation Centre, Uttar Pradesh |
No Objection Certificate |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E00-E89||Endocrine, nutritional and metabolic diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
Nil |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
64.00 Year(s) |
| Gender |
Both |
| Details |
1. History of diabetes mellitus for atleast 1 year
2. People who can understand Hindi and English .
3. People who are willing to participate |
|
| ExclusionCriteria |
| Details |
1. Central Nervous system disease
2. Peripheral Nervous system disease
3. Thyroid Disorders
4. Hearing Issue
5. Uncooperative patient
6. History of psychosomatic drugs in the past 6 months . |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Translating the questionnaire into the hindi language spoken in India ensures that it can be understood by a wider range of individuals including those who may not be proficient in English |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| A validated questionnaire in the hindi language is more likely to capture accurate information . |
6 months |
|
|
Target Sample Size
|
Total Sample Size="65"
Sample Size from India="65"
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)
|
18/03/2024 |
| 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="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Diabetes a complex and chronic metabolic disorder has become a pressing global health concern . In recent years the prevalence of diabetes has been steadily increasing and India has not been immune to this trend . NEED OF THE STUDY - Translating the questionnaire into hindi language ensures that it can be understood by a wider range of individuals including those who may not be proficient in English . This is crucial because cultural and linguistic factors can influence how people interpret and respond to questions . A validated questionnaire in hindi language is more likely to capture accurate information . AIM OF THE STUDY - The aim of this study is to assess the self management practices of diabetes among the Indian diabetic population by translating and validating an existing diabetes self management questionnaire and to investigate the relationship between self management practices and the prevalence of musculoskeletal disorders in this population . OBJECTIVES OF THE SUDY - To translate the diabetes self management questionnaire from its original language to other Indian language to ensure linguistic and cultural relevance . To investigate the association of diabetes self management questionnaire with the prevalence of musculoskeletal disorders among individuals with diabetes . |