| 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
|
|
|
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
|