Trial Outcomes & Findings for Leveraging Interactive Text Messaging to Monitor and Support Maternal Health in Kenya (NCT NCT05369806)

NCT ID: NCT05369806

Last Updated: 2023-12-29

Results Overview

AIM (Acceptability of Intervention Measure) score (Weiner et al instrument. Score range 1-5; higher score indicates higher acceptability)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 80 participants
• Primary outcome timeframe: Enrollment through 4 weeks postpartum
• Results posted on: 2023-12-29

Participant Flow

Participant milestones

Measure	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.
Overall Study STARTED	80
Overall Study COMPLETED	79
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure

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.

Overall Study Lost to Follow-up

1

Baseline Characteristics

Leveraging Interactive Text Messaging to Monitor and Support Maternal Health in Kenya

Baseline characteristics by cohort

Measure	Interactive Two-way SMS Dialogue n=80 Participants 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.
Age, Continuous	25 years n=93 Participants
Sex: Female, Male Female	80 Participants n=93 Participants
Sex: Female, Male Male	0 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	80 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	80 Participants n=93 Participants
Race (NIH/OMB) White	0 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment Kenya	80 participants n=93 Participants
Gestational age	31.4 weeks n=93 Participants

PRIMARY outcome

Timeframe: Enrollment through 4 weeks postpartum

AIM (Acceptability of Intervention Measure) score (Weiner et al instrument. Score range 1-5; higher score indicates higher acceptability)

Outcome measures

Measure

Interactive Two-way SMS Dialogue n=79 Participants 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.

Acceptability

4.0 units on a scale Interval 3.0 to 4.0

PRIMARY outcome

Timeframe: Enrollment through 4 weeks postpartum

Population: Participants who sent an urgent message

Minutes from urgent participant message to nurse response

Outcome measures

Measure

Interactive Two-way SMS Dialogue n=62 Participants 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.

Nurse Response Time

139.4 minutes Interval 29.7 to 1521.0

Adverse Events

Interactive Two-way SMS Dialogue

Serious events: 6 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Interactive Two-way SMS Dialogue n=80 participants at risk 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.
General disorders Infant hospitalization	5.0% 4/80 • Number of events 4 • Enrollment in pregnancy until 10 weeks post-partum Standard questionnaires administered at delivery phone call, 2-week and 6-week study visits.
Pregnancy, puerperium and perinatal conditions Intrauterine fetal demise	2.5% 2/80 • Number of events 2 • Enrollment in pregnancy until 10 weeks post-partum Standard questionnaires administered at delivery phone call, 2-week and 6-week study visits.

Other adverse events

Adverse event data not reported

Additional Information

Keshet Ronen

University of Washington

Phone: 2065854363

Email: keshet@uw.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place