| CTRI Number |
CTRI/2024/12/078390 [Registered on: 20/12/2024] Trial Registered Prospectively |
| Last Modified On: |
19/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Understanding Diabetes Care and Medication in Kundapura |
|
Scientific Title of Study
|
A study on medications, knowledge and adherence among the known type 2 Diabetes Mellitus patients in Kundapura, Udupi district |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Not Applicable |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Inchara A Hegde |
| Designation |
Primary Student Researcher |
| Affiliation |
Prasanna School of Public Health,MAHE |
| Address |
Department of Global Public Health Policy and Governance, Prasanna School of Public Health,MAHE,Manipal,Karnataka,
India
Udupi
KARNATAKA
576104
India |
| Phone |
9483211056 |
| Fax |
|
| Email |
inchara.psphmpl2023@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kumar Sumit |
| Designation |
Associate Professor |
| Affiliation |
Prasanna School of Public Health,MAHE |
| Address |
Room number 53,Department of Global Public Health Policy and Governance, Prasanna School of Public Health, MAHE, Manipal, Karnataka,
India
Udupi
KARNATAKA
576104
India |
| Phone |
8867620088 |
| Fax |
|
| Email |
kumar.sumit@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kumar Sumit |
| Designation |
Associate Professor |
| Affiliation |
Prasanna School of Public Health,MAHE |
| Address |
Room number 53,Department of Global Public Health Policy and Governance, Prasanna School of Public Health, MAHE, Manipal, Karnataka,
India
Udupi
KARNATAKA
576104
India |
| Phone |
8867620088 |
| Fax |
|
| Email |
kumar.sumit@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Prasanna School Of Public Health,Madhav Nagar,Eshwar Nagar,Manipal,Karnataka,India
576104
|
|
|
Primary Sponsor
|
| Name |
Dr Inchara A Hegde |
| Address |
Department of Global Public Health Policy and Governance,Prasanna School Of Public Health,MAHE,Manipal,Karnataka 576104 |
| Type of Sponsor |
Other [Self sponsored] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
Not Applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Inchara A Hegde |
Prasanna School of Public Health |
Department of Global Public Health Policy and Governance, Prasanna School of Public Health,MAHE,Manipal,Karnataka,
India
Udupi
KARNATAKA |
9483211056
inchara.psphmpl2023@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee-2(Student Research) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E118||Type 2 diabetes mellitus with unspecified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Both Inpatient and Outpatient department patients at Secondary care hospital Kundapura.
Both male and female with known type 2 diabetes Mellitus patients aged 45 years old and above.
Patients who were diagnosed with type 2 diabetes mellitus for more than a year before the study |
|
| ExclusionCriteria |
| Details |
Patients with known type I diabetes mellitus.
Patients with gestational diabetes.
Patients who are Terminally ill or Seriously ill.
Patients with cognitive impairment or inability to provide informed consent. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the Medications knowledge among known Type 2 Diabetes Mellitus patients in Kundapura Udupi district |
25 December 2024 to 1 March 2025 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the Factors influencing Adherence of medication |
30 March 2025 to 30 June 2025 |
|
|
Target Sample Size
|
Total Sample Size="207"
Sample Size from India="207"
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)
|
30/12/2024 |
| 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="7"
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
|
A study on medication knowledge and adherence among the known type 2 diabetes Mellitus patients in Kundapura aims to assess the impact of medication knowledge and adherence among diabetic patients, as this is a significant global health issue that has emerged due to rapid cultural, economic, and social transformations. Factors contributing to its rise include ageing populations, unplanned urban growth, dietary shifts characterized by higher intake of processed foods and sugary drinks, and obesity. decreased physical activity, and the adoption of unhealthy lifestyles. Previous studies have demonstrated that nonadherence to antidiabetic medications can result in poor glycemic control and can consequently lead to complications associated with disease progression, hospitalization, and premature disability. and mortality. It is important to educate the diabetic population about antidiabetic medication to prevent future complications of type 2 diabetes Mellitus. |