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CTRI Number  CTRI/2025/05/087405 [Registered on: 22/05/2025] Trial Registered Prospectively
Last Modified On: 16/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Process of Care Changes
Behavioral
Other (Specify) [health educational ]  
Study Design  Other 
Public Title of Study   Designing and evaluating a diabetes self-care toolkit for patients in an urban community of Central India. 
Scientific Title of Study   Developing and evaluating a self-care intervention package for type 2 diabetics residing in an urban field practice area of Central India A Mixed-Methods 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 Swapnil Tembhekar 
Designation  Junior Resident 
Affiliation  Government Medical College Nagpur 
Address  Plot number 63 Adarsh Nagar Near Pragati School Wadi Nagpur 440023

Nagpur
MAHARASHTRA
440023
India 
Phone  8828044876  
Fax    
Email  swapy0358@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sarita Wadhva 
Designation  Associate Professor 
Affiliation  Government Medical College and HospitalNagpur 
Address  Government Medicak College Ajni Road Medical Chowk Nagpur 440002

Nagpur
MAHARASHTRA
440002
India 
Phone  9422123822  
Fax    
Email  saritawadhva@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Swapnil Tembhekar 
Designation  Junior Resident 
Affiliation  Government Medical College Nagpur 
Address  Plot number 63 Adarsh Nagar Near Pragati School Wadi Nagpur 440023

Nagpur
MAHARASHTRA
440023
India 
Phone  8828044876  
Fax    
Email  swapy0358@gmail.com  
 
Source of Monetary or Material Support  
Indian Council of Medical Research, V. Ramalingaswami Bhawan, P.O. Box No. 4911Ansari Nagar, New Delhi - 110029, India 
 
Primary Sponsor  
Name  Dr Swapnil Tembhekar 
Address  Government Medicak College Ajni Road Medical Chowk Nagpur 440002 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
Nil  Nil 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Meenal Patle  Urban Health Training Centre UHTC Manewada  OPD no 2, UHTC Manewada, Shahu Nagar, Manewada Nagpur
Nagpur
MAHARASHTRA 		 9673026361

minalpatle1250@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Department of Pharmacology Government Medical College Nagpur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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 
Comparator Agent  NIl  NIl 
Intervention  Self care intervention package  Frequency of intervention- fortnightly in the first month. then monthly for next 5 months. Total intervention for 06 months.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Adults with confirmed diagnosis of Type 2 Diabetes Mellitus (T2DM) and on anti-diabetic medication for at least six months prior to onset of the study.
Willing to participate in group sessions, individual counselling, and follow-up activities.
 
 
ExclusionCriteria 
Details  Patients with severe complications of diabetes like heart problem, kidney disease that require specialized care.
Individuals with significant cognitive impairments
Those who refuse to provide consent.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Improve self care practices among T2DM patients
Improve self efficacy
Reduce distress due to diabetes
Provide insights into the barriers and enablers of diabetes self-care in an urban settings. 		 At endline 06 months 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in the medication adherance of the study participants  06 months 
 
Target Sample Size   Total Sample Size="86"
Sample Size from India="86" 
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)   30/05/2025 
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="0"
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [swapy0358@gmail.com].

  6. For how long will this data be available start date provided 10-05-2025 and end date provided 31-12-2026?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

India has the highest number of people with type 2 diabetes in the world, and many of them live in urban areas where managing diabetes can be challenging. Effective self-care, such as proper diet, exercise, taking medicines regularly, and foot care, helps in controlling diabetes and preventing serious complications. However, many patients struggle to follow these practices due to lack of awareness, limited resources, stress, and other personal or social factors.

This study aims to develop and test a self-care support program for patients with type 2 diabetes attending an urban health center in Central India. The program will include educational and motivational activities to help patients manage their condition better. The study will be done in three parts: first, understanding current self-care practices and challenges; second, designing and delivering the intervention; and third, evaluating how well it worked. A mix of surveys and interviews will be used to ensure the program is both scientifically sound and useful for real-life conditions.

The goal is to provide a practical, low-cost, patient-friendly self-care package that improves diabetes control and quality of life in urban, resource-limited settings.

 
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