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CTRI Number  CTRI/2023/07/054963 [Registered on: 07/07/2023] Trial Registered Prospectively
Last Modified On: 19/11/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Cluster Randomized Trial 
Public Title of Study   The DElhi DIabetes INTervention Trial (DEDINTT) 
Scientific Title of Study   A Stepped Wedge Cluster Randomized Trial (SwCRT) to evaluate the efficacy and cost effectiveness of a novel community led self management education module approach in improving the quality of diabetes care and reducing cardiovascular risk among known diabetes patients from Delhi 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Jitender Nagpal 
Designation  Deputy Medical Director 
Affiliation  Sitaram Bhartia Institute of Science and Research 
Address  Research-2 Room, Department of Pediatrics and Clinical Epidemiology, Sitaram Bhartia institute of Science and Research, B-16, Qutab Institutional Area, New Delhi

South
DELHI
110016
India 
Phone    
Fax    
Email  jitendernagpal@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Jitender Nagpal 
Designation  Deputy Medical Director 
Affiliation  Sitaram Bhartia Institute of Science and Research 
Address  Research-2 Room, Department of Pediatrics and Clinical Epidemiology, Sitaram Bhartia institute of Science and research, B-16, Qutab Institutional Area, New Delhi


DELHI
110016
India 
Phone    
Fax    
Email  jitendernagpal@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Jitender Nagpal 
Designation  Deputy Medical Director 
Affiliation  Sitaram Bhartia Institute of Science and Research 
Address  Research-2 Room, Department of Pediatrics and Clinical Epidemiology, Sitaram Bhartia institute of Science and research, B-16, Qutab Institutional Area, New Delhi


DELHI
110016
India 
Phone    
Fax    
Email  jitendernagpal@gmail.com  
 
Source of Monetary or Material Support  
Indian Council of Medical Research, V. Ramalingaswami Bhawan, P.O. Box No. 4911 Ansari Nagar, New Delhi - 110029 
 
Primary Sponsor  
Name  ICMR 
Address  New Delhi 
Type of Sponsor  Government funding agency 
 
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 Jitender Nagpal  Sitaram Bhartia Institute of Science and Research  Research-2 Room, Department of Pediatrics and Epidemiology, B-16, Qutab Institutional Area
South
DELHI 
01142111111

jitendernagpal@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SBISR Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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  Behaviour change through education  The intervention will be delivered by community leader using a standard EKDIN kit which includes all the educational material and devices required to understand LSM & DSME in the local language.  
Comparator Agent  Control Group before intervention  All clusters whcih are pending intervention serve as controls for variable duration of upto 18 months 
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Participated in DEDICOM-II study


 
 
ExclusionCriteria 
Details  1. Cancer, renal, hepatic or intestinal disease requiring continuing treatment or hospital
admission (>1 week in last 1 year).
2. Inability to communicate (due to mental illness or physical disability).
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Comparison of the HbA1c levels between the groups 3 months after the start of intervention.   36 months 
 
Secondary Outcome  
Outcome  TimePoints 
1. Comparison of HbA1c in the groups at ‘trial end point’
2. Comparison of Lipid profile, blood pressure, drug compliance & preventive checks between the groups
3. Comparison of sustainability of the gains in the groups
 
36 months 
 
Target Sample Size   Total Sample Size="350"
Sample Size from India="350" 
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)   01/11/2023 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
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  

Type-2 diabetes is a widely prevalent public health problem, the prevalence has been worsening and the aging population is especially vulnerable to Covid as well. Further, our two city-wide surveys (DEDICOM-II (1) and DEDICOM (2)) conducted 13 years apart (funded by ICMR) documented deterioration in glycemic control amongst known diabetes patients in Delhi especially in the socio-economically weaker sections. This makes it imperative to develop and test potentially effective and scalable interventions to improve glycemic control amongst known diabetes patients.

Available literature suggests that empowering the individual with self-management skills through education helps in achieving good and sustainable glycemic control (3, 4). Many studies on the subject have attempted doctor practice/diabetes educator based self-management education with varying success in the select populations affording and seeking such care. It is understandable that the effectiveness, scalability, and cost effectiveness of such interventions in the wider Indian population remains limited. In this context, our recently concluded cluster randomized community survey provides us with a unique opportunity of working with a pre-engaged community to co-develop a culturally and locally tailored self-management module-based Kit for Diabetes Intervention (EK-DIN). The kit will include all the educational material and devices required to understand DSME in the local language. We propose to subsequently evaluate the effectiveness of EK-DIN, when delivered using the services of trained community leaders, in improving glycemic control (primary outcome) using the Stepped Wedge Cluster Randomized Trial study design amongst the participants of DEDICOM-II (1). The sustainability, cost effectiveness, care seeking behavior and Quality of life impact of the intervention will also be studied as secondary outcomes. 

Reference

  1. Nagpal J, Rawat S, Goyal S, Lata AS. The poor quality of diabetes care in a cluster randomized community survey from Delhi (DEDICOM‐II): A crisis, an opportunity. Diabetic Medicine. 2021 Jan 27:e14530.
  2. Nagpal J, Bhartia A. Quality of diabetes care in the middle-and high-income group populace: the Delhi Diabetes Community (DEDICOM) survey. Diabetes care. 2006 Nov 1;29(11):2341
  3. Asha A, Pradeepa R, Mohan V. Evidence for benefits from diabetes education program. International journal of diabetes in developing countries. 2004;24:96-102.
  4. Nicoll KG, Ramser KL, Campbell JD, Suda KJ, Lee MD, Wood GC, Sumter R, Hamann GL. Sustainability of improved glycemic control after diabetes self-management education. Diabetes Spectrum. 2014 Aug 1;27(3):207-11.

 
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