Leveraging Interactive Text Messaging to Monitor and Support Maternal Health in Kenya (AI-NEO)

December 22, 2023 updated by: Keshet Ronen, University of Washington
Mobile health (mHealth) interventions such as interactive short message service (SMS) text messaging with healthcare workers (HCWs) have been proposed as efficient, accessible additions to traditional health care in resource-limited settings. Realizing the full public health potential of mHealth for maternal health requires use of new technological tools that dynamically adapt to user needs. This study will test use of a natural language processing computer algorithm on incoming SMS messages with pregnant people and new mothers in Kenya to see if it can help to identify urgent messages.

Study Overview

Detailed Description

Despite recent achievements in reducing child mortality, neonatal deaths remain high, accounting for 46% of all deaths in children under 5 worldwide. Addressing the high neonatal mortality demands efforts focused on getting proven interventions to at-risk neonates and their families. mHealth interventions have the potential to improve neonatal care and healthcare seeking by caregivers. Impact of such interventions will be maximized by ensuring healthcare workers accurately triage messages from caregivers and respond appropriately and quickly to messages that indicate an urgent medical question. This study adds to current knowledge by testing a novel natural language processing (NLP) tool to detect urgent messages. To the investigators' knowledge, such a tool has not been developed and empirically tested in a "real-world" implementation. Moreover, NLP tools to date have mostly been developed for high-resource languages; the investigators are not aware of any tools developed for detecting urgency in Swahili and Luo languages.

This study's overarching hypothesis is that development of an adaptive variant of the Mobile WACh SMS platform that automatically detects and prioritizes urgent messages will be feasible and acceptable to nurses and end-users, and will reduce the time from message receipt to HCW response.

Broad Objectives The study's overarching aim is to implement an NLP model into the Mobile WACh SMS platform and test its acceptability and impact on HCW response time.

Aim: Pilot the adapted Mobile WACh system (AI-NEO) and evaluate its acceptability and effect on nurse response time.

Eighty pregnant women will be enrolled to receive the AI-NEO SMS intervention. Women will be enrolled at >=28 weeks gestation and will receive automated SMS regarding neonatal health from enrollment until 6 weeks postpartum, and will have the ability to interactively message with study nurses. Participant messages will be automatically categorized by urgency. Intervention acceptability and recommended improvements will be evaluated among clients and nurses using quantitative and qualitative data collection at study exit (quantitative questionnaires with all client participants and qualitative interviews with 4 nurses). Nurse response time to urgent and non-urgent participant messages will be compared in the AI-NEO pilot vs. the ongoing Mobile WACh NEO trial, in which a non-adapted Mobile WACh system is used.

Study Type

Interventional

Enrollment (Actual)

80

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

      • Kisumu, Kenya
        • Kisumu County Hospital
    • Kisumu
      • Ahero, Kisumu, Kenya
        • Ahero Sub-District 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

14 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Pregnant
  • ≥28 weeks gestation
  • Daily access to a mobile phone (own or shared) on the Safaricom network
  • Willing to receive SMS
  • Age ≥14 years
  • Able to read and respond to text messages in English, Kiswahili or Luo, or have someone in the household who can help

Exclusion Criteria:

  • Currently enrolled in another research study

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: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Interactive two-way SMS dialogue
Participants will receive automated SMS messages with prompts to reply. They will have the ability to both respond to and initiate SMS dialogue. Trained Study Nurses will monitor and respond to participant messages. The NLP model will be applied to messages and will highlight those determined to be urgent.
This study uses Mobile WACh, a human-computer hybrid system that enables two-way SMS communication and patient tracking, to provide consistent support to women and their infants during the peripartum period and 6 weeks into the baby's life. Women will receive automated SMS messages targeting the appropriate peripartum period and will have the capability to respond and spontaneously message a nurse based at the clinic. During pregnancy, automated SMS will be delivered weekly. Two weeks prior to the participant's estimated due date (EDD), daily messaging will begin, and will continue for two weeks after delivery is ascertained. Thereafter, SMS will be delivered every other day. Women who experience pregnancy or infant loss will be enrolled into an infant loss track. The NLP model will be applied to incoming participant messages. Those flagged as urgent by the model will be flagged within the SMS system, allowing study nurses to triage and appropriately respond to those messages.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptability
Time Frame: Enrollment through 4 weeks postpartum
AIM (Acceptability of Intervention Measure) score (Weiner et al instrument. Score range 1-5; higher score indicates higher acceptability)
Enrollment through 4 weeks postpartum
Nurse Response Time
Time Frame: Enrollment through 4 weeks postpartum
Minutes from urgent participant message to nurse response
Enrollment through 4 weeks postpartum

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Keshet Ronen, PhD, University of Washington

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)

May 4, 2022

Primary Completion (Actual)

October 31, 2022

Study Completion (Actual)

October 31, 2022

Study Registration Dates

First Submitted

April 11, 2022

First Submitted That Met QC Criteria

May 5, 2022

First Posted (Actual)

May 11, 2022

Study Record Updates

Last Update Posted (Actual)

December 29, 2023

Last Update Submitted That Met QC Criteria

December 22, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • STUDY00014447
  • K18MH122978 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data from AI-NEO will be available at end of the project by contacting the study team at the University of Washington (keshet@uw.edu).

IPD Sharing Time Frame

End of project

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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