| 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
|
|
|
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
|
|
|
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:
- The
social acceptability of telemedicine services in comparison to
face-to-face consultations.
- The
difference in treatment-seeking behavior between those utilizing
telemedicine services and those relying on traditional clinics.
- 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.
|