| CTRI Number |
CTRI/2024/07/070798 [Registered on: 18/07/2024] Trial Registered Prospectively |
| Last Modified On: |
17/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Assessment of Knowledge, attitude, practice Among The Patients with TYPE 2 Diabetes Mellitus Disease
|
|
Scientific Title of Study
|
Assessment of Knowledge, Attitude and Practice Among The
Patients with TYPE 2 Diabetes Mellitus Regarding The Disease-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 |
Vismaya MT |
| Designation |
Student |
| Affiliation |
NGSM institute of pharmaceutical science |
| Address |
Department of pharmacy practice, NGSM Institute of pharmaceutical science, NITTE(Deemed to be university) Mangalore,575018
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8590066493 |
| Fax |
|
| Email |
vismayamt5@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Barma Naga Raju |
| Designation |
Assistant professor |
| Affiliation |
NGSM institute of pharmaceutical science |
| Address |
Assistant Professor, Department of pharmacy practice, NGSM Institute of pharmaceutical science, NITTE(Deemed to be university) Mangalore,575018
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9949617946 |
| Fax |
|
| Email |
barmanagaraju@nitte.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chethan Subramanya |
| Designation |
Associate professor |
| Affiliation |
KS Hegde medical academy |
| Address |
Associate Professor ,Department of General medicine , Justice K.S Hegde charitable Hospital, paneer, derlakatte,mangalore,575018
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8762552454 |
| Fax |
|
| Email |
chethansub@nitte.edu.in |
|
|
Source of Monetary or Material Support
|
| Department of pharmacy practice NGSM institute of pharmaceutical sciences, Paneer, Deralakatte, Manglore, Karnataka, 575018 |
| Justice KS Hegde Charitable Hospital, Deralakatte, Mangaluru, Karnataka, 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 Chethan Subramanya |
Justice KS Hegde Charitable Hospital |
Department of General Medicine Justice KS Hegde Charitable Hospital Deralakatte, Mangaluru Dakshina Kannada Karnataka 575018
Dakshina Kannada
KARNATAKA |
8762552454
chethansub@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 |
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 |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients aged 18 and above 18
2) Patients diagnosed with Type 2 DM
3)OPD visiting patients
4)Patients willing to give consent |
|
| ExclusionCriteria |
| Details |
1)Type 1DM patients
2)Patients not willing to give consent
3)Psychiatric, Neurological and Terminal illness patients
4) Pregnant and lactating women |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The study gives the KAP among patients with T2DM regarding the disease |
8 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
From this study patients will be able to know their knowledge in diabetes, and
help the clinicians and health care workers to provide more information and
awareness about the diabetes |
8 momths |
|
|
Target Sample Size
|
Total Sample Size="209"
Sample Size from India="209"
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)
|
31/07/2024 |
| 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
|
It is an cross sectional study will be conducted in Department of General medicine, Justice KS Hegde Charitable Hospital. Patients who is aged18 years above and with T2DM visiting general medicine OPD department of the Justice K.S. Hegde Charitable Hospital will be included. Their data is collected from the treatment chart, laboratory reports and patient interview. Here the patients will be receiving questionnaire and their KAP regarding the disease will be assessed.• To develop, validate, and reliability of knowledge, attitude, and practice questionnaire among type 2 diabetes mellitus patients. • To assess knowledge, attitude, and practice among type 2 diabetes mellitus patients. • To compare knowledge, attitude, and practice scores with demographical and clinical parameters of the type 2 diabetes mellitus patients.
Sample size- 209 |