m-Health System for Tracking Kangaroo Mother Care and Temperature in Southern India

June 28, 2021 updated by: St. John's Research Institute

Evaluation of a m-Health System for Tracking Kangaroo Mother Care and Temperature for Providing Feedback to Family Care Givers or Front-line Workers to Enhance Kangaroo Mother Care Adherence

The product innovation is a wearable device that (combined with a smartphone and back-end analytics system) acts as a sensor, processor and actuator, and is therefore designed to identify critical parameters (Kangaroo Mother Care adherence and temperature of neonate on a 24/7 basis and temperature of mother during these episodes), make intelligent and early diagnosis of (persistent or impending) neonatal hypothermia, maternal/neonatal fever and non-adherence to Kangaroo Mother Care and then trigger audio or visual alerts (via the wearable or smart-mobile phone) for action by the care-giver or front-line healthcare worker to enhance Kangaroo Mother Care duration or referral to a health facility as needed.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Project design and implementation plan:

The logic model envisioned in this study as i) wearable sensors, technology design and development with research team personnel as 'inputs'; ii) data analytics deployment with detection of abnormalities as 'processes'; and iii) feedback alerts appraisal as the 'outputs' for this phase of testing.

Experimental plan comprises of two steps: a non-clinical phase and a clinical phase.

i) The non-clinical phase comprises of the design, development and deployment of the data capture and analytics system. This includes mobile phone app building with features such as push notifications, offline data storage and synchronization on connectivity, local data analysis (with sequentially increasing capabilities as more data comes in) and alerting stakeholders. In addition, capability development of primary nodes for temporary storage and real-time data analysis as also for long-term data storage capabilities that could be scaled to district-level and state-level expansion in future will be done. Data monitoring capacity will be built on real-time visualization dashboards and raising alerts for targeted stakeholders. The entire computational hardware, algorithms/AI engine, network architecture, overall data visualization including heat maps (infrastructure) for this proposed study will be developed by industry experts (will be subcontracted).

ii)In the second phase, it is proposed to undertake a technological-feasibility study as a small-scale clinical trial (in a convenient sample of 20 mother-baby pairs) for testing in real-world conditions while the mother-infant pairs are in the hospital for a few days and when they are discharged for follow-up at home for up to a week. This phase will also include a qualitative research component to study acceptability and feasibility of alerting and actionable advisories sent to care-givers and field staff. All data obtained from this program will reside within dedicated servers with storage facilities within the selected hospital from where mother-infant pairs are recruited. Institutional Ethics Committee approval, clinical trial registration and data safety monitoring board constitution will be undertaken to protect human research participants.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Karnataka
      • Bangalore, Karnataka, India, 560034
        • St Johns Medical College and Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 days to 49 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Stable LBW babies who are less than 2000 grams
  • Kangaroo care provider who could preferably be the mother or any other family member

Exclusion Criteria:

  • Extreme preterm infants (corrected gestational age less than 28 weeks)
  • Any family member who is unwilling to hold the infant in Kangaroo Mother Care position with the wearable device or if presenting with any infection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DEVICE_FEASIBILITY
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Wearable device with smart mobile phone
20 mother/care provider-infant pairs practicing Kangaroo Mother Care, from a tertiary super-specialty hospital selected to wear the device ( few days in the hospital and for a week at home when discharged)
Device: Wearable device with smart mobile phone
The wearable device will act as a sensor designed to identify critical parameters such as Kangaroo Mother Care adherence and temperature of the infant 24/7 and of the mother-infant pairs during these sessions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of hypothermia episodes through the wearable device (remote bio-monitoring - RBM) in real world
Time Frame: 5 months
1. Number of hypothermia (less than 36.5 degree centigrade) episodes
5 months
Evaluation of touch through the wearable device (remote bio-monitoring - RBM) in real world
Time Frame: 5 months
1. No Kangaroo Mother Care ( Skin to skin contact between mother and baby) for 6 hours (alerted through RBM device)
5 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Development of entire computational hardware of the remote bio-monitoring device
Time Frame: 8 months
  1. No of alert messages from the RBM to project staffs.
  2. No of heat map views - total and within 24 hrs.
  3. No of responses to failure of normal temperature range (36.5-37 degree centigrade/ Kangaroo Mother Care alerts)
8 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. John's Research Institute

Collaborators

Bill and Melinda Gates Foundation

Investigators

  • Principal Investigator: Prem K Mony, MD; MSc-Epi, St. John's Research Institute, Bangalore 560034

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 1, 2018

Primary Completion (ACTUAL)

March 31, 2019

Study Completion (ACTUAL)

December 31, 2019

Study Registration Dates

First Submitted

December 19, 2017

First Submitted That Met QC Criteria

June 10, 2021

First Posted (ACTUAL)

June 18, 2021

Study Record Updates

Last Update Posted (ACTUAL)

July 1, 2021

Last Update Submitted That Met QC Criteria

June 28, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OPP1182699

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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