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CTRI Number  CTRI/2023/08/056834 [Registered on: 23/08/2023] Trial Registered Prospectively
Last Modified On: 11/07/2023
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Comparing regular and digital literacy of trained health care workers 
Scientific Title of Study   Remote Evaluation of Regular and Digital literacy of Trained health care workers: A Quantitative Observational Study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Suresh Munuswamy 
Designation  Associate Professor, (IIPH-H) Coordinator, MSc and PhD: Health Informatics by PHFI - AcSIR 
Affiliation  Indian Institute of Public Health - Hyderabad 
Address  HI Rapid Lab, IIPH Lab, room no 1, Health Informatics Deprtment Sy. No: 376,377,384,388-391, 387 Premavathi Pet, Rajendra Nagar Mandal

Hyderabad
TELANGANA
500030
India 
Phone  9959560333  
Fax    
Email  s.munuswamy@iiphh.org  
 
Details of Contact Person
Scientific Query  
Name  Dr Suresh Munuswamy 
Designation  Associate Professor, (IIPH-H) Coordinator, MSc and PhD: Health Informatics by PHFI - AcSIR 
Affiliation  Indian Institute of Public Health - Hyderabad 
Address  HI Rapid Lab, IIPH Lab, room no 1, Health Informatics Deprtment Sy. No: 376,377,384,388-391, 387 Premavathi Pet, Rajendra Nagar Mandal


TELANGANA
500030
India 
Phone  9959560333  
Fax    
Email  s.munuswamy@iiphh.org  
 
Details of Contact Person
Public Query  
Name  Dr Suresh Munuswamy 
Designation  Associate Professor, (IIPH-H) Coordinator, MSc and PhD: Health Informatics by PHFI - AcSIR 
Affiliation  Indian Institute of Public Health - Hyderabad 
Address  HI Rapid Lab, IIPH Lab, room no 1, Health Informatics Deprtment Sy. No: 376,377,384,388-391, 387 Premavathi Pet, Rajendra Nagar Mandal

Hyderabad
TELANGANA
500030
India 
Phone  9959560333  
Fax    
Email  s.munuswamy@iiphh.org  
 
Source of Monetary or Material Support  
HI Rapid Lab, IIPH Lab, room no 1, Health Informatics Deprtment Sy. No: 376,377,384,388-391, 387 Premavathi Pet, Rajendra Nagar Mandal 
 
Primary Sponsor  
Name  Hi Rapid Lab Pvt Ltd 
Address  Hi Rapid Lab Private Limited Indian Institute of Public Health Laboratories Sy. No: 376,377,384,388-391&387 Premavathi Pet, Himayatsagar, Himayatnagar, Rajendra Nagar Mandal, Kismatpur Hyderabad - 500030 Telangana, INDIA 
Type of Sponsor  Other [Grant Support] 
 
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 Suresh Munuswamy  Hi Rapid Lab Pvt Ltd  HI Rapid Lab, IIPH Lab, room no 1, Health Informatics Deprtment Sy. No: 376,377,384,388-391, 387 Premavathi Pet, Rajendra Nagar Mandal
Hyderabad
TELANGANA 		 09959560333

s.munuswamy@iiphh.org 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee IIPH - Hyderabad  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  No health conditions studied 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Participants who have prior experience in handling mobile applications and have gone through the
training session and its evaluation. 
 
ExclusionCriteria 
Details  Participants who dont have prior experience in handling mobile applications and have not gone through the
training session and its evaluation. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To determine the effectiveness & total time taken by the healthcare workers to perform each task in regular & digital literacy.   5 days 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the efficiency of T-HCPs with their socio-demographic details like job role, age, & experience.  5 days 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
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)   01/09/2023 
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="0"
Months="0"
Days="15" 
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 - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol

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

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response (Others) -  Data will be available for a limited time period of 3 years provided with due request

  6. For how long will this data be available start date provided 01-09-2023 and end date provided 01-09-2026?
    Response (Others) -  3 years

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   The Pandemic has made imperative use of digital technologies in the medical sector for registration, screening, diagnosis, management, and treatment. To handle these solutions in an effective and efficient way, it is significant to be digitally literate. HI, Rapid Lab has made an application and has planned to launch it for Primary health care to screen and manage NTDs. A quantitative questionnaire was prepared to assess the skills regarding basic and digital literacy among Trained Health care personnel while using the application. 
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