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CTRI Number  CTRI/2018/12/016532 [Registered on: 05/12/2018] Trial Registered Prospectively
Last Modified On: 03/12/2018
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Diagnostic
Preventive
Screening 
Study Design  Single Arm Study 
Public Title of Study   e health initiatives for health  
Scientific Title of Study   e health initiatives for villages in Rajasthan 
Trial Acronym  - 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  vaseem naheed baig 
Designation  ASSOCIATE PROFESSOR 
Affiliation  RUHS - CMS JAIPUR 
Address  RUHS -CMS, SECOND FLOOR, RUHS- CMS, SEC. 18 , PRATAP NAGAR JAIPUR
Dept. of COMMUNITY MEDICINE, Second floor, RUHS- CMS. Sec. 18 PRATAP NAGAR JAIPUR
Jaipur
RAJASTHAN
302033
India 
Phone  9414606193  
Fax    
Email  drvaseemnaheed@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  vaseem naheed baig 
Designation  ASSOCIATE PROFESSOR 
Affiliation  RUHS - CMS JAIPUR 
Address  RUHS -CMS, SECOND FLOOR, RUHS- CMS, SEC. 18 , PRATAP NAGAR JAIPUR
Dept. of community medicine, second floor, SEC 18,RUHS-CMS, PRATAP NAGAR JAIPUR
Jaipur
RAJASTHAN
302033
India 
Phone  9414606193  
Fax    
Email  drvaseemnaheed@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  vaseem naheed baig 
Designation  ASSOCIATE PROFESSOR 
Affiliation  RUHS - CMS JAIPUR 
Address  RUHS -CMS, SECOND FLOOR, RUHS- CMS, SEC. 18 , PRATAP NAGAR JAIPUR
RUHS -CMS, SECOND FLOOR, RUHS- CMS, SEC. 18 , PRATAP NAGAR JAIPUR
Jaipur
RAJASTHAN
302033
India 
Phone  9414606193  
Fax    
Email  drvaseemnaheed@yahoo.com  
 
Source of Monetary or Material Support  
Rajasthan University Of Health Sciences( RUHS), Jaipur. 
 
Primary Sponsor  
Name  RUHS 
Address  SEC 18, PRATAP NAGAR JAIPUR RAJASTHAN 
Type of Sponsor  Research institution 
 
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 
VASEEM NAHEED BAIG  KAPURWALA & LAKHESRA  DEPT. OF COMMUNITY MEDICINE, SECOND FLOOR, RUHS-CMS. SEC. 18, PRATAP NAGAR,JAIPUR
Jaipur
RAJASTHAN 
9414606193

drvaseemnaheed@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ETHICS COMMITTEE S.P.MEDICAL COLLEGE, BIKANER  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  all volunteering individuals of the two villages, all age groups 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  nil  nil 
Intervention  screening, diagnostic, preventive  testing for anemia, hypertension, diabetes and obesity. iec videos 
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  99.00 Year(s)
Gender  Both 
Details  all volunteering residents of two villages.
birth until death. 
 
ExclusionCriteria 
Details  all non consenting individuals 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
better mother and child health and better health as screening and compliance of non communicable diseases.  1 YEAR 
 
Secondary Outcome  
Outcome  TimePoints 
better health of all individuals, and to go away with paper work and develop technology efficient health workers  1 YEAR 
 
Target Sample Size   Total Sample Size="5000"
Sample Size from India="5000" 
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)   15/12/2018 
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="5"
Days="30" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   none yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Title: e-Health Initiative for Villages in Rajasthan.

 Background: India is a strong country with billion plus people, increasing population in India over-burdens the health care structure in the country.

 While, those living in cities and big towns have access to high end health services, the millions of people living in rural India, particularly in the remote parts of the country face problems of  inadequate facilities and poor access to healthcare.

  So as to provide better health care access to the priceless human resources, which in turn can make India healthier too, we want to use e health initiatives.

  The health care industry has generated huge amounts of data, driven by record keeping, compliance and regulatory requirements and patient care .

  Now, the e-health initiative has transformed the health care system to become much more efficient, less expensive and achieve better quality.

  As India too is making strides in the field of e Health. We have developed  an App  namely Health Smart app , made with the concept of iconic data entry or data entry with a few clicks .

This innovative technology is a way to improve the performance of health care systems by linking various systems.

  Rationale: The present initiative to create health smart villages shall create an impact on:

             neonatal and child health including vaccinations,

             maternal health,

             infectious disease and

             non-communicable disease.

  Mobile technology based surveillance of healthcare workers shall lead to better delivery of preventive care

  Constant population surveillance shall lead to early diagnosis of epidemics.

  Equal focus on childhood and adult mortality shall reap healthcare and economic dividends.

  Real-time feedback can lead to rapid policy initiatives and improve practice.

  Academic enrichment

 

Objectives of the study

 

     1. To focus on health issues from womb to tomb of every individual.

     2. To create technology empowered primary health care workers.

3. To use conventional technologies as well as e-health initiatives in disease surveillance and management.

4. To use e - health in disease screening, and timely intervention.

5. To strengthen health care delivery system and referral system.

 

 Methodology:

Is a prospective cohort study

 will track changing lifestyles, risk factors and chronic disease using periodic standardized data collection in rural area. This study is being conducted in three phases:

A Vanguard phase

Recruitment phase

Follow-up phase

       i ) A Vanguard phase 

    During which all aspects of the protocol were further refined and tailored , development of  android application for tablet, development of training module for ASHA,  final training and standardization of methods was done .

ii) Recruitment phase: (3months)

During which all individuals of  the village  were recruited and underwent detailed baseline assessments. During this phase, the initial cross-sectional analysis using baseline data was done.

iii) Follow-up phase:(8 month)

Consists of follow-up of all subjects every monthly, for up to 1 year, to document any changes in the health profile of all the participants.

 

Sampling Frame

1)    Selection criteria: 

          such villages are choosen which had difficult approach or the health services were inadequate.

 2) Location and names  -

               (i)  Lakhesra  -  30 km from RUHSCMS,  Jaipur    under Luniyawas      PHC on Jaipur  Agra road.

     (ii)  Kapurwala - 25 kms  from RUHSCMS, Jaipur under Dadiya PHC on Diggi Malpura road.

Health Smart App

  An android based application (Health Smart App) developed to be used on tablets.

  The health worker (ASHA) provided with tablets which are GPS, skype  and 3G enabled .

  It consists of pop up videos for increasing awareness and knowledge of various health related issues of the general population.

   To go for real time data collection with visualisation and real time processing of information at central loaction. (RUHS College of medical sciences, Jaipur) .

Methods

  Training of ASHA

  We  trained the ASHA’s on different aspects

  First of all we trained her to use the tablet.

  In the subsequent process we  made her friendly with Health Smart Android App

  She was made acquainted with different forms of the Performa, entries to be made on the tablet itself.

  She was trained to take different anthropometric measurements, BP & measure blood glucose level by glucometer and hb estimations through training modules & real time demonstrations.

  We trained these ASHA’s already working in rural area with the e health initiatives which will remove the complete file work and help her to take decision, perform large scale screening for non communicable diseases, update them with alerts like list of people for vaccination , list of antenatal and post natal mothers so as to create health smart  villages.

Overview of Data Collection

•      Standardized, interviewer-based questionnaires are being used to collect detailed information at the community, family and individual level through clicks on the tablet .

•      Physical measures include anthropometry, blood pressure using automated equipment.

•      The data would be transferred directly to the central computer & report on various aspects will be generated automatically on daily basis through the server, So as to capture any deviation from normal in the health status of the community & family.

   Follow up...

  Regular check-up of those who are at high risk (Hypertension, Diabetes Mellitus, Anaemia) in form of  B.P. monitoring, blood sugar estimation and haemoglobin estimation.

 For those found hypertensive and pre hypertensive  monthly B.P. monitoring will be done.

  For diabetics and prediabetics monthly blood sugar estimation will be done and

   Anaemics will be given 3 month of IFA tablets and there haemoglobin estimation will be done after 1 month of completion of the IFA course to see the effect .

  ASHA /CHW will refer those patients to FRU’s. We will also organise specialist visits once a month to the village itself, so as to provide treatment there itself.

  Tracking of these newly diagnosed cases for regular treatment and follow up by ASHA/ CHW.

  Reporting of any new event in the household in form of morbidity, mortality and birth will be done on daily basis.

  Supervision and monitoring of ASHA / CHW by the coordinating team will be done weekly.

         We are training and retraining the ashas to use these e health initiatives  so as to empower them in providing better services at the grass root level  to the people and also be able to screen the population for various NCD’s and provide timely referral so that we can control the occurrence of these diseases.

 
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