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
|
|
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
|
|
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 - Nagpal J, Rawat S, Goyal S, Lata AS. The poor quality of diabetes care in a cluster randomized community survey from Delhi (DEDICOMâ€II): A crisis, an opportunity. Diabetic Medicine. 2021 Jan 27:e14530.
- 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
- Asha A, Pradeepa R, Mohan V. Evidence for benefits from diabetes education program. International journal of diabetes in developing countries. 2004;24:96-102.
- 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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