| CTRI Number |
CTRI/2025/08/092708 [Registered on: 08/08/2025] Trial Registered Prospectively |
| Last Modified On: |
08/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to see how well people with high blood sugar level in rural Central India are following their medicines, food habits, exercise, and regular doctor visits. |
|
Scientific Title of Study
|
Assessment of Adherence to Comprehensive Diabetes Management and Self
care Practices in Type 2 Diabetic Patients from Central Rural India: A Mixed
Method 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 |
Dr Kimaya Parkhe |
| Designation |
Junior resident |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Dept. of Community Medicine, 3rd Floor, JNMC Building, Sawangi Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
8169090489 |
| Fax |
|
| Email |
dr.kimayaparkhe@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abhay Mudey |
| Designation |
Professor, Community medicine |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Dept. of Community Medicine, 3rd Floor, JNMC Building, Sawangi Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
9373187088 |
| Fax |
|
| Email |
abhaymudey67@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kimaya Parkhe |
| Designation |
Junior resident |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Dept. of Community Medicine, 3rd Floor, JNMC Building, Sawangi Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
8169090489 |
| Fax |
|
| Email |
dr.kimayaparkhe@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute Of Higher Education and Research, Sawangi, Wardha 442001 |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute Of Higher Education and Research |
| Address |
DMIHER, Sawangi, Wardha, 442001. |
| Type of Sponsor |
Private medical college |
|
|
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 Kimaya Parkhe |
Jawaharlal Nehru Medical College |
Dept. of Community Medicine, 3rd Floor, JNMC Building, Sawangi Meghe
Wardha
MAHARASHTRA |
8169090489
dr.kimayaparkhe@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Datta Meghe institute of Higher Research and 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 |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patient who voluntarily give consent to participate |
|
| ExclusionCriteria |
| Details |
Seriously ill or bedridden patients
Pregnant women
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Socio-demographic profile
Medication adherence rate
Dietary adherence rate
Physical activity adherence rate
Follow-up adherence rate
Factors associated with adherence
Patient-reported barriers
Healthcare provider perceptions
Family/caregiver perceptions
Systemic or administrative challenges
Recommendations for improved adhere |
At single point study |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="359"
Sample Size from India="359"
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)
|
01/09/2025 |
| 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="1"
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
|
The study titled "Assessment of Adherence to Comprehensive Diabetes Management and Self-Care Practices in Type 2 Diabetic Patients from Central Rural India: A Mixed Method Study" aims to evaluate how well patients with Type 2 Diabetes Mellitus adhere to various aspects of their management, including medication intake, dietary practices, physical activity, and follow-up visits. It will also assess the socio-demographic characteristics of these patients and identify factors influencing adherence. Using both quantitative data and qualitative insights from patients, healthcare providers, and caregivers, the study seeks to understand barriers to adherence and provide recommendations to strengthen diabetes care in rural settings. |