- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05369806
Leveraging Interactive Text Messaging to Monitor and Support Maternal Health in Kenya (AI-NEO)
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Kisumu, Kenya
- Kisumu County Hospital
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Kisumu
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Ahero, Kisumu, Kenya
- Ahero Sub-District Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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 |
|---|---|
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Acceptability
Time Frame: Enrollment through 4 weeks postpartum
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AIM (Acceptability of Intervention Measure) score (Weiner et al instrument.
Score range 1-5; higher score indicates higher acceptability)
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Enrollment through 4 weeks postpartum
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Nurse Response Time
Time Frame: Enrollment through 4 weeks postpartum
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Minutes from urgent participant message to nurse response
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Enrollment through 4 weeks postpartum
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Keshet Ronen, PhD, University of Washington
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00014447
- K18MH122978 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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