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CTRI Number  CTRI/2025/09/095490 [Registered on: 30/09/2025] Trial Registered Prospectively
Last Modified On: 27/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Screening 
Study Design  Other 
Public Title of Study   Enhancing non communicable disease screening in central India. 
Scientific Title of Study   Enhancing Non Communicable disease screening in central India-A cluster field trial analyzing the quality and coverage of population based screening by frontline health workers. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrUday Narayan Rajput 
Designation  Junior Resident 
Affiliation  Mahatma Gandhi Institute of Medical Sciences 
Address  Department of Community Medicine,old hospital building,bapu kuti road,Mahatma Gandhi Institute of Medical Sciences (MGIMS),Sevagram,Wardha, Maharashtra. pin-442102. India.

Wardha
MAHARASHTRA
442102
India 
Phone  9049903353  
Fax    
Email  udayrajput@student.mgims.ac.in  
 
Details of Contact Person
Scientific Query  
Name  DrDharampal Dhambare 
Designation  Professor 
Affiliation  Mahatma Gandhi Institute of Medical Sciences 
Address  Department of Community Medicine,old hospital building,bapu kuti road,Mahatma Gandhi Institute of Medical Sciences (MGIMS),Sevagram,Wardha, Maharashtra. pin-442102. India.

Wardha
MAHARASHTRA
442102
India 
Phone  9021682765  
Fax    
Email  dgdambhare@mgims.ac.in  
 
Details of Contact Person
Public Query  
Name  DrDharampal Dambhare 
Designation  Professor 
Affiliation  Mahatma Gandhi Institute of Medical Sciences ,Sevagram,Wardha. 
Address  Department of Community Medicine,old hospital building,bapu kuti road,Mahatma Gandhi Institute of Medical Sciences (MGIMS),Sevagram,Wardha, Maharashtra. pin-442102. India.

Wardha
MAHARASHTRA
442102
India 
Phone  9021682765  
Fax    
Email  dgdambhare@mgims.ac.in  
 
Source of Monetary or Material Support  
Mahatma Gandhi Institute of Medical Sciences, Sevagram ,Wardha,Maharashtra,India.442102 
 
Primary Sponsor  
Name  Mahatma Gandhi Institute of Medical Sciences,Sevagram,Wardha,Maharashtra,India.442102 
Address  Dr,Sushila Nair School of Public Health(Incorporating Department of Community Medicine)old hospital building,bapu kuti road,Mahatma Gandhi Institute of Medical Sciences (MGIMS),Sevagram,Wardha, Maharashtra. pin-442102. India. 
Type of Sponsor  Other [Government Medical College and Hospital.] 
 
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 
DrUday Narayan Rajput  Mahatma Gandhi Institute of Medical Sciences  Dr.Sushila Nair School of Public Health(Incorporating Department of Community Medicine)old hospital building,bapu kuti road,Mahatma Gandhi Institute of Medical Sciences (MGIMS),Sevagram,Wardha, Maharashtra. pin-442102. India.
Wardha
MAHARASHTRA 		 9049903353

udayrajput@student.mgims.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Mahatma Gandhi Institute of Medical Sciences Sevagram Institutional Ethics Committee for research on human subjects  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Not Applicable 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Routine Training to FLHWs  Routine NPNCD training and Screening of non communicable diseases under national NPNCD programme by frontline health workers in control group in another PHC in different Block 
Intervention  Skilled training to FLHW of PHC  The intervention package will consist training modules, supervision checklists, and standardized protocols. The proposed intervention package for the cluster field trial aims to enhance the capacity of frontline health workers (FLHWs) in screening for Non-Communicable Diseases (NCDs) through a combination of structured experiential skill based training to reinforce the capacity building under the national NCD programme. The intervention will include a one-day modular training program for FLHWs focusing on key NCDs such as hypertension, diabetes with a focus on risk factors, screening guidelines, referral mechanism, and counselling. Interactive learning methods, including case scenarios, group discussion and hands-on practice with screening tools, will be used to enhance engagement and skill development. FLHWs will be provided with screening checklists, and simplified Standard Operating Procedures (SOPs) to ensure adherence to national guidelines and consistency in data collection. To sustain the quality of screening regular supportive supervision visits will be conducted by PHC level supervisors, who will provide on-site monitoring, observation, and real time feedback. Where feasible, the intervention will aim to integrate existing digital infrastructure (such as NCD mobile applications) to assist FLHWs in risk assessment, real-time data capture, and tracking referrals and follow-up.  
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Individuals above the age of 30 years who are permanant resident of the study area and enrolled for national NPNCD programme. 
 
ExclusionCriteria 
Details  Individuals above 30 years who are severely ill and bedridden. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Quality of NCD screening will be increase in intervention group compared to control group.  6 Months 
 
Secondary Outcome  
Outcome  TimePoints 
Coverage rate will be higher in intervention group.  6 Months 
 
Target Sample Size   Total Sample Size="300"
Sample Size from India="300" 
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)   01/11/2025 
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 - 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 [udayrajput2509@gmail.com].

  6. For how long will this data be available start date provided 01-01-2029 and end date provided 01-01-2035?
    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  

 Summary:

Non-communicable diseases (NCDs) like diabetes, hypertension, cardiovascular diseases, and cancer are leading causes of morbidity and mortality in India, especially among adults aged 30 and above. Despite the rollout of the National Programme for Prevention and Control of NCDs (NP-NCD) and tools like the Community-Based Assessment Checklist (CBAC), challenges persist in the quality and coverage of NCD screening by frontline health workers (FLHWs), including ASHAs, ANMs, and CHOs.

This cluster field trial aims to evaluate whether structured experiential skills-based training of FLHWs improves the quality and coverage of NCD screening in rural Central India compared to routine practice. The study involves 60 clusters from two separate administrative blocks (30 intervention and 30 control clusters) and includes both quantitative and qualitative assessments.

The primary objective is to assess improvements in screening quality (accuracy, completeness, and data reliability). The secondary objective is to measure increased coverage among adults over 30 years of age.

Methodology includes baseline and end-line surveys, pre- and post-training assessments, IDIs with health workers, and FGDs with community members. Quantitative data will be analyzed using statistical tests, and qualitative data will undergo thematic content analysis.

The expected outcome is a measurable improvement in both data quality (validated CBAC, vitals, anthropometric records) and screening coverage in the intervention group. Ethical clearance will be obtained from the Institutional Ethics Committee, and individuals identified with NCDs during the study will be referred for appropriate care.

 
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