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CTRI Number  CTRI/2024/10/076070 [Registered on: 30/10/2024] Trial Registered Prospectively
Last Modified On: 23/10/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Screening 
Study Design  Other 
Public Title of Study   A study to enhance the healthcare faciltities supporting conventional clinics in remote areas using digital tools and telemedicine  
Scientific Title of Study   Acceptance of digital medical tools and telemedicine in hard-to-reach areas as augumentation of conventional physical clinics and face-to-face consultation: An interventional 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  Ramesh Kumar Huda 
Designation  Scientist - C (Information Technology) 
Affiliation  ICMR- NIIRNCD 
Address  Server Room, ICMR-NIIRNCD (Desert Medicine Research Centre), Pali Road, Bhagat ki Kothi, Jodhpur Raj., 342005

Jodhpur
RAJASTHAN
342005
India 
Phone  02912729730  
Fax    
Email  ramesh.hudda@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Ramesh Kumar Huda 
Designation  Scientist - C (Information Technology) 
Affiliation  ICMR- NIIRNCD 
Address  Server Room, ICMR-NIIRNCD (Desert Medicine Research Centre), Pali Road, Bhagat ki Kothi, Jodhpur Raj., 342005

Jodhpur
RAJASTHAN
342005
India 
Phone  02912729730  
Fax    
Email  ramesh.hudda@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Ramesh Kumar Huda 
Designation  Scientist - C (Information Technology) 
Affiliation  ICMR- NIIRNCD 
Address  Server Room, ICMR-NIIRNCD (Desert Medicine Research Centre), Pali Road, Bhagat ki Kothi, Jodhpur Raj., 342005

Jodhpur
RAJASTHAN
342005
India 
Phone  02912729730  
Fax    
Email  ramesh.hudda@gmail.com  
 
Source of Monetary or Material Support  
Indian Council of Medical Research, V. Ramalingaswami Bhawan, P.O. Box No. 4911 Ansari Nagar, New Delhi - 110029, India 
 
Primary Sponsor  
Name  ICMR-NIIRNCD 
Address  ICMR-NIIRNCD (Desert Medicine Research Centre), Pali Road, Bhagat ki Kothi, Jodhpur Raj., 342005 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ramesh Kumar Huda  Ramaniya PHC  Room No. 1, Ramaniya PHC Siwana Block, Balotra
Barmer
RAJASTHAN 
9602755600

ramesh.hudda@gmail.com 
Dr Ramesh Kumar Huda  Siner PHC  Room No. 1, Siner PHC, Siwana Block, Balotra
Barmer
RAJASTHAN 
9602755600

ramesh.hudda@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Biomedical and health ressearch  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E663||Overweight, (2) ICD-10 Condition: E101||Type 1 diabetes mellitus with ketoacidosis, (3) ICD-10 Condition: E46||Unspecified protein-calorie malnutrition,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Non-Telemedicine Support group  Control group will serve as a basis for comparison in evaluating the effectiveness of the intervention. The data will be collected on individuals who fall sick and need medical assistance during the weekly door-to-door survey in the control group. There will be no intervention in this group.  
Intervention  Telemedicine Support group  In the Interventional group, the 05 paramedical staff and ASHA will be deployed for data collection/facilitate the use of the sensor kit and telemedicine platform (i.e., ASHA and one Project staff for every Village), 1 Research Assistant for overall field monitoring and two medical officers and PHC doctors will be deployed to provide dedicated services on the telemedicine platform and guide the participants if they further require clinic/hospital visits. For the Control group, ASHA will collect the required data and 1 Research Assistant for overall monitoring. We are targeting to conduct studies for 20 months to assess the social acceptability of digital medical tools and the effectiveness of telemedicine services. The duration of the Intervention will be 12 months and frequency will be depending upon the patients availing telemedicine services during these 12 months. We cannot predict the exact frequency at this time. 
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  99.00 Year(s)
Gender  Both 
Details  common diseases
non communicable disease
hypertension
 
 
ExclusionCriteria 
Details  emergency cases and invasive procedures 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Increased acceptance of telemedicine services  The outcome will be assessed after 12 months of the Intervention. 
 
Secondary Outcome  
Outcome  TimePoints 
effectiveness of digital medical tools for first level screening  24 months 
 
Target Sample Size   Total Sample Size="25000"
Sample Size from India="25000" 
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)   04/11/2024 
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 - NO
Brief Summary  

Rural and hard-to-reach areas in India face significant healthcare challenges, including limited access to medical facilities, a shortage of qualified healthcare professionals, and inadequate infrastructure at Primary Health Centers (PHCs). The COVID-19 pandemic further exacerbated these challenges, emphasizing the need for scalable, remote healthcare solutions to improve medical access in underserved regions. Conventional healthcare delivery through physical clinics is often impractical in these areas, as patients have to travel long distances to access even basic services. The rapid expansion of telecommunication infrastructure and the growing use of smartphones in rural areas provide an opportunity to introduce telemedicine as a supplementary tool for healthcare delivery. Telemedicine enables remote consultation and diagnosis, thus offering potential solutions to bridge the gap between healthcare providers and patients in hard-to-reach areas. However, existing telemedicine platforms, such as the Government of India e-Sanjeevani, lack the ability to measure vital body parameters in real time, a crucial element in providing effective teleconsultation services. This interventional study assesses the acceptance and effectiveness of digital medical tools and telemedicine to complement traditional healthcare services in hard-to-reach areas. The study introduces low-cost Internet of Things (IoT) devices to measure vital body parameters like heart rate, blood pressure, and oxygen saturation. These devices will be integrated with a telemedicine platform to enable real-time monitoring and consultation. The study will be conducted over 12 months in two groups of villages—an intervention group, which will have access to telemedicine services and digital tools, and a control group, which will not. The study aims to evaluate the following:

  1. The social acceptability of telemedicine services in comparison to face-to-face consultations.
  2. The difference in treatment-seeking behavior between those utilizing telemedicine services and those relying on traditional clinics.
  3. The effectiveness of digital medical tools in providing first-level screening for various health conditions.

By utilizing real-time data collection, AI-driven systems for data analysis, and dedicated teleconsultation services, this trial seeks to establish telemedicine and digital tools as viable and sustainable healthcare solutions for rural India. The expected outcomes include increased acceptance of telemedicine, enhanced healthcare access, and reduced strain on physical clinics. Moreover, the insights generated from this trial will guide future policies and strategies for implementing telemedicine in rural areas on a larger scale.

 
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