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CTRI Number  CTRI/2024/04/066298 [Registered on: 25/04/2024] Trial Registered Prospectively
Last Modified On: 23/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Improving maternal and child health in tribal areas through data science. 
Scientific Title of Study   Data Science for improving maternal and child health in developing communities: an Action Research in a tribal area of Andhra Pradesh 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Arun Mitra Peddireddy 
Designation  Research Scholar 
Affiliation  Sree Chitra Tirunal Institute for Medical Sciences and Technology, Trivarndrum 
Address  Room No 4220, Second Floor, Achutha Menon Centre for Health Science Studies Building, Sree Chitra Tirunal Institute for Medical Sciences and Technology, Trivandrum, Medical College PO, Trivandrum

Thiruvananthapuram
KERALA
695011
India 
Phone  9503563356  
Fax    
Email  dr.arunmitra@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Biju Soman 
Designation  Professor and Head 
Affiliation  Sree Chitra Tirunal Institute for Medical Sciences and Technology, Trivarndrum 
Address  Head of the Department Room, First Floor, Achutha Menon Centre for Health Science Studies Building, Sree Chitra Tirunal Institute for Medical Sciences and Technology, Trivandrum,
Medical College PO, Trivandrum
Thiruvananthapuram
KERALA
695011
India 
Phone  9447862736  
Fax    
Email  bijusoman@sctimst.ac.in  
 
Details of Contact Person
Public Query
 
Name  Arun Mitra Peddireddy 
Designation  Research Scholar 
Affiliation  Sree Chitra Tirunal Institute for Medical Sciences and Technology, Trivarndrum 
Address  Room No 4220, Second Floor, Achutha Menon Centre for Health Science Studies Building, Sree Chitra Tirunal Institute for Medical Sciences and Technology, Trivandrum, Medical College PO, Trivandrum


KERALA
695011
India 
Phone  9503563356  
Fax    
Email  dr.arunmitra@gmail.com  
 
Source of Monetary or Material Support  
SEED Division, DST, Govt of India 
 
Primary Sponsor  
Name  SCTIMST, Trivandrum 
Address  Sree Chitra Tirunal Institute for Medical Sciences and Technology, Medical College PO, 605011 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
ITDA Rampachodavaram  Rampachodavaram, ASR District, Andhra Pradesh 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Arun Mitra  Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST), Trivandrum  Achutha Menon Centre for Health Science Studies (AMCHSS), Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST), Trivandrum,
Thiruvananthapuram
KERALA 
9503563356

dr.arunmitra@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST), Trivarndrum  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  The study participants are the medical officers at the PHC level under the administrative jurisdiction of Integrated Tribal Development Agency (ITDA), Rampachodavaram.  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  - Mid-level programme managers working in the maternal and child health (MCH) sector in tribal settings of Andhra Pradesh.
- Health care workers and health professionals working at the primary health centres (PHCs) in the target area.
- Stakeholders involved in MCH service delivery and decision-making, including community leaders and representatives 
 
ExclusionCriteria 
Details  Participants who are not able to provide informed consent. 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Development of decision support tools to monitor maternal and child health activities at the field level in a participatory way  1 year 
 
Secondary Outcome  
Outcome  TimePoints 
Identify the Data Sources used for Decision Making at the local level  baseline, 3 months 
Understand the Practices, Needs and Challenges related to data utilization in the local level  3 months, 6 months 
 
Target Sample Size   Total Sample Size="6"
Sample Size from India="6" 
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)   08/05/2024 
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="0"
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  
BACKGROUND:

The ubiquitous digitization of the healthcare landscape has led to unique challenges and opportunities for public health. Though advancing technology has shown promise in addressing much of the public health challenges, this has yet to percolate to vulnerable and developing populations. Tribal communities are arguably at the far end of the spectrum regarding health inequities and continue to be plagued by public health issues. They warrant novel, innovative and tailored solutions while also being conscious of inherent ethical and administrative challenges. Maternal and child health are critical indicators of a community’s overall well-being. Poor maternal and child health outcomes can have long-lasting negative effects on individuals, families, and entire communities. By focusing on maternal and child health in a tribal community, such innovative solutions can not only improve health outcomes for mothers and children, but also address systemic issues that contribute to poor health outcomes. Additionally, maternal and child health is a priority area for local administration and program managers in developing communities, making it an ideal focus area for the study. The literature review suggests that in order to effectively use data and technology for informed decision-making in developing communities, it is important to address these contributing factors through a combination of approaches. One possible approach is the use of action research, which involves working closely with community members and stakeholders to understand their needs and perspectives, and co-creating solutions that are tailored to their specific context. Additionally, the use of data science methods can help transform routinely collected data into actionable insights at the local level. By working closely with community members and stakeholders, and using a combination of public health, data science, and action research methods, it may be possible to effectively use data and technology to improve reproductive and child health services in developing communities. T

PURPOSE:

The proposed study is aimed at developing a stakeholder-led decision support tool to aid primary health center medical officers in maternal and child health care (MCH) delivery in tribal areas under the administrative jurisdiction of Integrated Tribal Development Agency (ITDA), Rampachodavaram, Alluri Sitharama Raju (ASR) District, Andhra Pradesh. The purpose is to explore the potential of data science in transforming data on reproductive and child health services into evidence for informed decision-making in tribal areas of Alluri Sitharama Raju (ASR) District, Andhra Pradesh. 

OBJECTIVES:
Specificially, the study aims to address the following objectives:
  • Identifying and mapping data sources on MCH care delivery in a tribal setting.
  • Understanding the current state of data use, practices and challenges in the primary health centre (PHC) level.
  • Exploring data on maternal and child health (MCH) services and interpret the findings in relation to the local context.
METHODS:

The study participants of the proposed study will consist of various stakeholders from community of ITDA Rampachodavaram in Alluri Sitharama Raju (ASR) district of Andhra Pradesh. This will include medical officers, peripheral health workers, government officials and healthcare providers, as well as members of the community who are directly impacted by the reproductive and child health services provided in the area.

Inclusion Criteria:
Mid-level programme managers working in the maternal and child health (MCH) sector in tribal settings of Andhra Pradesh. 
Health care workers and health professionals working at the primary health centres (PHCs) in the target area.
Stakeholders involved in MCH service delivery and decision-making, including community leaders and representatives
Exclusion Criteria: 
Participants who are not able to provide informed consent.

DATA ANALYSIS:
The conduct of the study and data collection procedures will involve the following steps:
Interviews: 
Qualitative semi-structured interviews will be conducted with key stakeholders, including health care providers, community leaders, and local health program managers. These interviews will be conducted at the Primary Health Centers (PHCs) and sub-centers, as well as in the communities served by these facilities. 
Discussions: 
Group discussions will be conducted with health care providers and community members to understand their perspectives on data use, availability and quality. These discussions will be held at the PHCs and in the communities. 
Stakeholder Engagements: 
The stakeholder engagement component of the action research project will be conducted in a number of steps as follows:
Preparation and planning: 
The research team will first identify and invite key stakeholders to participate in the engagement activities, based on their relevance to the project objectives. The team will then prepare a detailed plan of the engagement activities, including the format and timeline of the activities, the specific locations where they will be performed, and the participants who will be involved.
Stakeholder Workshops: 
The research team will conduct one or more stakeholder workshops in which key stakeholders from the primary health center (PHC) and other relevant organizations will be invited to participate. The aim of the workshops is to facilitate open and collaborative discussions between the stakeholders about the use of data in day-to-day activities and decision processes in maternal and child health (MCH) service delivery in the tribal setting. The format of the workshops will be a mix of interactive presentations, group discussions, and question-answer sessions.
By whom: The principal investigator will conduct the data collection activities, including interviews, and discussions.
The analysis of the datasets will be carried out by the PI under guidance of Co-PI using data science approach. It will include steps of data extraction, pre-processing, exploratory data analysis, statistical data analysis and interpretation. The data collected from the stakeholder engagements, observations and interviews will be analyzed in a systematic and structured manner

 
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