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CTRI Number  CTRI/2025/04/083779 [Registered on: 01/04/2025] Trial Registered Prospectively
Last Modified On: 20/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Screening 
Study Design  Cluster Randomized Trial 
Public Title of Study   Efficacy of community level health care providers training for screening peripheral nerve complication seen in Diabetes Mellitus in Dakshina Kannada District of Karnataka 
Scientific Title of Study   Effectiveness of a Community Health Officers training program for the screening of Diabetic Peripheral Neuropathy in Dakshina Kannada District of Karnataka 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Arsha Anna Roy 
Designation  PhD scholar 
Affiliation  Kasturba Medical College, Mangalore 
Address  Department of Community Medicine, Kasturba Medical College, Light house hill road, Mangalore

Dakshina Kannada
KARNATAKA
575001
India 
Phone  9566909064  
Fax    
Email  arsha_na@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Prasanna Mithra P 
Designation  Additional Professor 
Affiliation  Kasturba Medical College, Mangalore 
Address  Department of Community Medicine, Kasturba Medical College, Light house hill road, Mangalore

Dakshina Kannada
KARNATAKA
575001
India 
Phone  9449243260  
Fax    
Email  prasanna.mithra@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Arsha Anna Roy 
Designation  PhD scholar 
Affiliation  Kasturba Medical College, Mangalore 
Address  Department of Community Medicine, Kasturba Medical College, Light house hill road, Mangalore


KARNATAKA
575001
India 
Phone  9566909064  
Fax    
Email  arsha_na@yahoo.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  Kasturba Medical College, Mangalore 
Address  Kasturba Medical College Mangalore, Manipal Academy of Higher Education, Manipal, Lighthouse Hill Road, Mangalore, 575001 Karnataka, India. 
Type of Sponsor  Private medical college 
 
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 Prasanna Mithra P  Kasturba Medical College, Mangalore  Department of Community Medicine, 3rd floor, room no.1, Lighthouse Hill Road, Mangalore, 575001,Karnataka, India.
Dakshina Kannada
KARNATAKA 		 9449243260

prasanna.mithra@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Kasturba Medical College, Mangalore   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  The intervention is training based on module. The trial participants are Community Health Officers. They will be receiving the training. 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Module based Training  Training for the screening of Diabetic Peripheral Neuropathy for Community Health Officers. Taluks will be considered as clusters and randomization will be used to allocate taluks to intervention and control arm. Participants in the intervention arm will receive a training from April 2025. This will be the only training for the participants. Pre and Post test will be done before and after training. Follow-up will be done at every 6 months based on the training to understand the effectiveness of the training from October 2025 till October 2027. First follow up- October 2025 Second follow up- April 2026 Third follow up- October 2026 Fourth follow up - April 2027 Fifth follow up- October 2027 
Comparator Agent  Standard or Routine Training  Study Taluks in the control arm will continue with the existing standard procedure for screening. Participants will be followed up in every 6 months from October 2025 till October 2027. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Participants consent to the study
Participants who continue as Community Health Officers for the next 2 years 
 
ExclusionCriteria 
Details  Participants who refuse consent
Participants who refuse the follow up
Participants who will be leaving the job 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. Change in the mean score of knowledge, perception and practice after the intervention
2. Number of patients screened for DPN before and after intervention
3. Number of patients referred to higher centres before and after intervention
 		 1. At baseline, 24 weeks, 48 weeks, 72 weeks, 96 weeks
2.At baseline,24 weeks, 48 weeks, 72 weeks, 96 weeks
3. At baseline,24 weeks, 48 weeks, 72 weeks, 96 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  NA 
 
Target Sample Size   Total Sample Size="328"
Sample Size from India="328" 
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)   01/04/2025 
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="2"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 - All of the individual participant data collected during the trial, after de-identiļ¬cation.

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

  3. Who will be able to view these files?
    Response - Anyone

  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 (Others) -  Data will be made available in an open public repository - Open Science Framework (osf.io)

  6. For how long will this data be available start date provided 24-09-2027 and end date provided 31-12-2053?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary   Community Health Officers are mid-level health providers placed at Ayushman Arogya Mandirs. Though are involved in the management of Diabetes, currently there is no existing practice for the screening of Diabetic Peripheral Neuropathy at the primary level. The study aims to assess the effectiveness of training program in screening Diabetic Peripheral Neuropathy for Community Health Officers. 
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