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CTRI Number  CTRI/2025/04/085098 [Registered on: 17/04/2025] Trial Registered Prospectively
Last Modified On: 15/04/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Preventive
Process of Care Changes
Behavioral 
Study Design  Cluster Randomized Trial 
Public Title of Study   ICMR NHRP STEPS-INDIA Multi-Centre Study  
Scientific Title of Study   Strategies for enhanced population engagement and Health Care Seeking for Prevention and Control of Hypertension and Diabetes in India The STEPS INDIA Multi Centre Study  
Trial Acronym  STEPS INDIA 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Roopa Shivashankar 
Designation  Scientist E 
Affiliation  ICMR 
Address  Room No 204 First floor ICMR Headquarters Ansari Nagar

New Delhi
DELHI
110029
India 
Phone  9312065025  
Fax    
Email  shivashankar.r@icmr.gov.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Roopa Shivashankar 
Designation  Scientist E 
Affiliation  ICMR 
Address  Room No 204 First floor ICMR Headquarters Ansari Nagar


DELHI
110029
India 
Phone  9312065025  
Fax    
Email  shivashankar.r@icmr.gov.in  
 
Details of Contact Person
Public Query  
Name  Dr Abhijit P Pakhare 
Designation  Professor  
Affiliation  AIIMS BHOPAL 
Address  Community and Family Medicine AIIMS Campus Rd Saket Nagar Habib Ganj

Bhopal
MADHYA PRADESH
462026
India 
Phone  8989097515  
Fax    
Email  Abhijit.CFM@aiimsbhopal.edu.in  
 
Source of Monetary or Material Support  
Indian Council of Medical Research Headquarters V Ramalingaswami Bhawan PO Box No 4911 Ansari Nagar New Delhi 110029  
 
Primary Sponsor  
Name  ICMR Headquarters 
Address  Indian Council of Medical Research Headquarters V Ramalingaswami Bhawan PO Box No 4911 Ansari Nagar New Delhi 110029  
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
ICMR  Indian Council of Medical Research Headquarters V Ramalingaswami Bhawan PO Box No 4911 Ansari Nagar New Delhi 110029  
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 6  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Abhijit Phakare  AIIMS Bhopal  Dr Abhijit Pakhare Room No. 14,2nd Floor Medical College Building, Department of Community and Family Medicine All India Institute of Medical Sciences Saket Nagar Bhopal Madhya Pradesh
Bhopal
MADHYA PRADESH 		 8989097515

abhijit.cfm@aiimsbhopal.edu.in 
Dr Sitikantha Banerjee  AIIMS Jammu  Dr Sitikantha Banerjee Room No.511F, Department of Community Medicine, Academic Block All India Institute of Medical Science Vijaypur Jammu Pincode 184120
Jammu
JAMMU & KASHMIR 		 8967981649

drsitikantha@gmail.com 
Dr Lena Charlette  AIIMS Madurai  Dr Lena Charlette Room No.526, Department of Community and Family Medicine All India Institute of Medical Sciences Madurai 5th Floor Faculty Block Government Medical College Campus Ramanathapuram 623 504
Madurai
TAMIL NADU 		 9531877163

lenacharlette@gmail.com 
Dr Radhika Shrivastav  HRIDAY  Dr Radhika Shrivastav Room No:2, Department of Community Medicine, HRIDAY Secretariat of the Healthy India Alliance India NCD Alliance N-25 2nd Floor Green Park Extension New Delhi 110016
Jhajjar
HARYANA 		 9810796696

radhika@hriday-shan.org 
Dr Ipsita Debata  KIMS Bhubaneswar  Dr Ipsita Debata Campus No.5 Department of Community Medicine School of Medicine KIMS Bhubaneswar
Khordha
ORISSA 		 9972483237

drdebataipsita@gmail.com 
Dr Abhishek Raut  MGIMS, Sevagram  Dr Abhishek Raut Room No.5, Department of Community Medicine, Mahatma Gandhi Institute of Medical Sciences Sevagram Wardha 442102 Maharashtra
Wardha
MAHARASHTRA 		 7083170552

abhishekraut@mgims.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 6  
Name of Committee  Approval Status 
IEC HRIDAY  Approved 
IEC AIIMS Jammu  Approved 
IEC AIIMS MADURAI  Approved 
IEC KIMSBhubaneswar  Approved 
IEC MGIMS  Approved 
IHEC AIIMS BHOPAL  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I10||Essential (primary) hypertension, (2) ICD-10 Condition: E115||Type 2 diabetes mellitus with circulatory complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Community Level:Community norm building and support   Monthly-Peer groups meetings /Volunteers meetings/Community monitoring/Community spaces Quarterly - Campaigns Frequency-18 months 
Comparator Agent  Control arm- Standard Care Practices   The activities/interventions proposed as part of the NP-NCD program for prevention and control of NCDs including the community engagement activities shall continue without any interference from the project team. Consistency of standard care across clusters 6- monthly exit interview of patients, 3 per facility will be conducted to assess the consistency of standard care across clusters.  
Intervention  Family Level:Providing supportive care   Promoting healthy life choices and monitoring for compliance. Family support Family screening Family will help prevent and identify complications early. Frequency-18 months 
Intervention  HWC Level: Catalyst and Mobilizer   It will act as a drug dispensary and facilitate screening for complications. It will provide follow up health check-ups and referral whenever needed. Bi-directional tele-consultation facility Frequency-18 month 
Intervention  Individual Level:Self-care  Risk identification and lifestyle modifications Screening and follow ups Treatment and care adherence Frequency-18 months 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Taking anti-hypertensive or anti-diabetic drugs
Detected as having Hypertension OR Diabetes during screening
Detected as having elevated blood pressure
Detected as having prediabetes OR impaired glycemia 
 
ExclusionCriteria 
Details  Consent refusal for participation
Planning to migrate out from the cluster during the study period
Individuals confined to bed or with severe chronic conditions (Stroke, Chronic kidney
disease)  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.Identification of potential interventions to engage communities for prevention and control of selected Non communicable diseases.Identification of key stakeholders.2.Development of final model 2 of eCES and communication packages required for implementation of interventions 3.For those below 60 years systolic blood pressure more than 140 mmHg and diastolic blood pressure more than 90 mm Hg. For those above 60 years SBP HbA1c below 7 Methods of measurement.  Baseline,12 Months,18 Months
 
 
Secondary Outcome  
Outcome  TimePoints 
Reversal of
prehypertension or
elevated blood
pressure
Reversal of
prediabetes
Improvement in
proportion of persons
with hypertension who
are on treatment
Improvement in
proportion of persons
with diabetes who are
on treatment
Reduction in
prevalence of risk
factors 		 Nine months with three months overlap with phase 2 
 
Target Sample Size   Total Sample Size="3900"
Sample Size from India="3900" 
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)   01/05/2025 
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="4"
Months="0"
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   Hypertension and Diabetes are the most prevalent of all Non-communicable diseases (NCDs). These NCDs are a risk factor for cardiovascular diseases (CVDs), and stroke. Together all NCDs are estimated to account for 63% of all deaths, thus making them the leading causes of death globally and in India. The control of hypertension and diabetes has been shown to reduce premature mortality and prevent or delay the development of complications. However, current control rates of both of these conditions are suboptimal suggesting a need for better and more effective strategies. Meaningful engagement of communities and those living with NCDs has been highlighted in the revised Operational Guidelines of NP-NCD and the WHO Framework on Meaningful Engagement of People Living with NCDs and Mental and Neurological Conditions. Empowering communities to actively manage their health can lead to sustainable, long-lasting solutions for preventing and managing NCDs. It can address not only their health needs but also social, environmental, and behavioural factors. These approaches can lead to a more comprehensive understanding of the factors contributing to NCDs and facilitate more effective solutions. This multi-district research study is aimed at developing and testing strategies for improving community engagement and population healthcare seeking, to improve the cascade of care from screening to control of Hypertension and Diabetes.
The primary objective of the proposed research is to evaluate the effectiveness of enhanced community engagement strategies (eCES) targeted at hypertension and diabetes care within the primary healthcare setting compared to the current standard of care in achieving blood pressure and glycemic control among adults with hypertension and diabetes respectively. The proposed eCES will be co-developed with the communities so that these are context-specific, and socio-culturally appropriate. The current standard of care are existing strategies under the NP-NCD program. As secondary objectives the proposed research aims to evaluate the effectiveness of eCES on population-level screening and diagnosis of hypertension or diabetes; proportions initiated on treatment, adherence to medication and lifestyle advice, and follow-up (continuity of care) among the adults with hypertension or diabetes; reversal among persons with prehypertension (elevated blood pressure) or prediabetes (impaired glycemia), population-level preventive and promotive efforts to reduce the common shared modifiable risk factors for NCDs (namely physical inactivity, unhealthy diet, tobacco use and alcohol use) and level of community participation in the NCD related activities. The study will also evaluate the implementation fidelity of the eCES.   
 
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