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| ID | Type | Description | Link |
|---|---|---|---|
| K18MH122978 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interactive two-way SMS dialogue | Experimental | 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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interactive two-way SMS dialogue | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability | 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 | Minutes from urgent participant message to nurse response | Enrollment through 4 weeks postpartum |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Keshet Ronen, PhD | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ahero Sub-District Hospital | Ahero | Kisumu County | Kenya | |||
| Kisumu County Hospital |
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).
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End of project
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Interactive two-way SMS dialogue: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Interactive two-way SMS dialogue: 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Acceptability | AIM (Acceptability of Intervention Measure) score (Weiner et al instrument. Score range 1-5; higher score indicates higher acceptability) | Posted | Median | Inter-Quartile Range | units on a scale | Enrollment through 4 weeks postpartum |
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Enrollment in pregnancy until 10 weeks post-partum
Standard questionnaires administered at delivery phone call, 2-week and 6-week study visits.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Interactive two-way SMS dialogue: 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infant hospitalization | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Keshet Ronen | University of Washington | 2065854363 | keshet@uw.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 15, 2021 | Dec 7, 2023 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 15, 2021 | Dec 7, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D066087 | Perinatal Death |
| D003863 | Depression |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003643 | Death |
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All participants are enrolled into the MWACh SMS system
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| Kisumu |
| Kenya |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Gestational age | Median | Inter-Quartile Range | weeks |
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| Primary | Nurse Response Time | Minutes from urgent participant message to nurse response | Participants who sent an urgent message | Posted | Median | Inter-Quartile Range | minutes | Enrollment through 4 weeks postpartum |
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| 0 |
| 80 |
| 6 |
| 80 |
| 0 |
| 80 |
| Intrauterine fetal demise | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
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| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |