FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/11/076609 [Registered on: 11/11/2024] Trial Registered Prospectively
Last Modified On: 08/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Quasi-experimental design]  
Study Design  Single Arm Study 
Public Title of Study   Population level non-communicable disease status monitoring digital dashboard in Puducherry 
Scientific Title of Study   Design and implementation of Digital Health Dashboard for monitoring Non-Communicable Disease Care in selected Primary Health Centres of Puducherry - A quasi-experimental 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  Aishwarya V 
Designation  PG student 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research 
Address  Room number:2 Floor:02 Department of Preventive and social medicine Division: MPH Jipmer International School of Public Health(JISPH) JIPMER Campus Rd, Gorimedu, Dhanvantari Nagar

Pondicherry
PONDICHERRY
605006
India 
Phone  9442888542  
Fax    
Email  dras3232@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Subitha L 
Designation  Additional Professor 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research 
Address  Room no:5 floor no:3 Division PSM Dept of Preventive and social medicine Jipmer International School of Public Health(JISPH) JIPMER Campus Rd, Gorimedu, Dhanvantari Nagar, Puducherry, 605006.

Pondicherry
PONDICHERRY
605006
India 
Phone  8489216058  
Fax    
Email  subitha.l@gmail.com  
 
Details of Contact Person
Public Query  
Name  Subitha L 
Designation  Additional Professor 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research 
Address  Room no:5 floor no:3 Division PSM Dept of Preventive and social medicine Jipmer International School of Public Health(JISPH) JIPMER Campus Rd, Gorimedu, Dhanvantari Nagar, Puducherry, 605006.

Pondicherry
PONDICHERRY
605006
India 
Phone  8489216058  
Fax    
Email  subitha.l@gmail.com  
 
Source of Monetary or Material Support  
Jawaharlal Institute of Postgraduate Medical Education and Research Dhanvantri nagar, Gorimedu, Puducherry, India, 605006 
 
Primary Sponsor  
Name  Aishwarya V 
Address  JIPMER Campus Rd, Gorimedu, Dhanvantari Nagar, Puducherry, 605006. 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
Subitha L  JIPMER Campus Rd, Gorimedu, Dhanvantari Nagar, Puducherry, 605006. 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Subitha L  JIPMER Rural Health Centre  Room number: 05 Ground floor, Division: NCD clinic Ramanathapuram, Puducherry, 605502
Pondicherry
PONDICHERRY 		 8489216058

subitha.l@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee for observational studies  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Health care workers 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Digital health dashboard (for health care workers)  the intervention is digital health dashboard for a total of 3 months with PDSA cycles once every 2 weeks, designed for the health care workers to monitor the non-communicable disease care delivered at the selected 2 primary health centres in Puducherry, India 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Health care workers -
1)Medical officers (MO),
2)Public Health Nurses (PHNs),
3)Nursing Officers (NOs),
4)ANMs,
5)ASHAs,
6)NCD experts,
7)technology experts,
8)program officers (NP-NCD) 
 
ExclusionCriteria 
Details  1)Health care workers not aware of NCD application
2)Health care workers not working in NCD care 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
The NCD dashboard will be tested for
1. System implementation and performance
2. Usability
3. User engagement (website metrics)
4. Work performance
5. Technology acceptance (Perceived usefulness,
Perceived ease of use, Attitude, Behavioral intention
to use) 		 the intervention period is for 3 months, with plan-do-study-analyse (PDSA cycle) once every month 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   20/11/2024 
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="0"
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-identification.

  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 - Researchers who provide a methodologically sound proposal.

  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 - Proposals should be directed to [dras3232@gmail.com].

  6. For how long will this data be available start date provided 15-11-2024 and end date provided 15-07-2025?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
This is a quasi-experimental study planned in JIPMER’S Rural and Urban health centres. Sampling method chosen was purposive sampling, where health care workers(HCW) who are Medical officers (MO), Public Health Nurses (PHNs), Nursing Officers (NOs), ANMs, ASHAs, NCD experts, technology experts and program officers (NP-NCD) will be included at different stages of the study (with an estimated sample size of 30). The first phase of the study will be formative assessment, to understand the need of the HCWs through qualitative interviews (in-depth interviews). The second phase of the study would be to co-design the user-centric dashboard for monitoring the NCD care delivered at the selected 2 PHCs. Baseline assessment of the HCW will include basic socio demographic and work-related characteristics, training on NCD application, years of usage, readiness to use new technology/ data. The NCD patient record maintained in the form of excel sheets at the 2 centres will be used to develop the dashboard. The dashboard will be hosted in a website whose login ID/ URL will be shared with the respective stakeholders. A repetitive PDSA (Plan-Do-Study-Act) cycles for a period of 3 months will be done. The regular testing of dashboards and feedbacks from the weekly/ monthly reviews will iteratively improve the dashboard performance fitting to the needs of the stakeholders. The endline assessment will be done to test the System implementation and performance, Usability, User engagement (website metrics), Work performance, Technology acceptance (Perceived usefulness, Perceived ease of use, Attitude, Behavioral intention to use). 
 
Close