Mobile WACh NEO: Mobile Solutions for Neonatal Health and Maternal Support
Study Details
Study Description
Brief Summary
To improve neonatal mortality, it is critical to engage families, especially mothers, in essential newborn care (ENC) and appropriate care-seeking for neonatal illness as well as to support maternal mental health and self-efficacy. This randomized controlled trial (RCT) aims to determine the effect and mechanisms of a two- way mobile health (mHealth) SMS intervention, Mobile WACh NEO, on neonatal mortality, essential newborn practices, care-seeking and maternal mental health at four sites in Kenya.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
High-impact essential newborn care practices and interventions are available to support neonatal survival, but coverage remains a challenge in sub-Saharan Africa, where neonatal mortality is unacceptably high. Many newborns continue to die at home without health care services being sought. The reasons are multifactorial, at the societal, health system, and family levels. Decisions made within the household and the family's ability to reach care play a large part in determining neonatal outcomes. It is estimated that up to 80% of neonatal and child deaths may have delays in recognition of infant illness and decision to seek care. Two-way mobile health (mHealth) communication strategies can enable mothers to remotely interact with a healthcare worker (HCW) and receive real-time education, counseling, encouragement, motivation and decisional guidance to support care-seeking decisions and ultimately neonatal health and survival.
The investigators developed a unique two-way SMS platform (Mobile WACh) that combines automated SMS messaging and dialogue with a HCW. The team adapted this approach for intensive neonatal support and evaluations (Mobile WACh NEO). Mobile WACh NEO (MWN) enhances the benefits of SMS messaging by engaging mothers with SMS communication and bringing timely information and support - asking critical questions at crucial times in order to assess the needs and health of newborns and assist in care seeking decisions.
This is a randomized controlled trial of the MWN intervention among 5,020 participants (2,510 MWN arm, 2,510 control arm) to determine the effect of MWN on neonatal mortality, essential newborn care, care seeking, and maternal mental health in the first 6 weeks postpartum.
Aim 1: To determine the effect of Mobile WACh NEO on neonatal mortality, compared to no SMS control.
Aim 2: To examine the effect of Mobile WACh NEO on maternal implementation of essential newborn care and care seeking behavior.
Aim 3: To examine the effects of Mobile WACh NEO on maternal social support, self-efficacy and depression.
Finally, investigators will explore the associations between maternal mental health, implementation of essential newborn care, neonatal care seeking and participant engagement by SMS.
Study Design
Arms and Interventions
| 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. |
Behavioral: Interactive two-way SMS dialogue
We will utilize Mobile WACh, a human-computer hybrid system that enables seamless 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 theoretically grounded 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 for the remaining four weeks. Women who experience pregnancy or infant loss will be enrolled into an infant loss track where they will receive messages of support.
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| No Intervention: No SMS Control Control receiving standard of care. |
Outcome Measures
Primary Outcome Measures
- Neonatal mortality [28 days postpartum]
Death during 1st 28 days of life
Secondary Outcome Measures
- Early neonatal mortality [7 days postpartum]
Death during 1st 7 days of life
- Initiation of early breastfeeding [1 hour postpartum]
Number of participants initiating breastfeeding in 1st hour of life
- Exclusive breastfeeding [6-weeks postpartum]
Cessation of exclusive breastfeeding in 1st 6 weeks of life
- Thermal care [24 hours postpartum]
Number of participants giving infant a bath in 1st 24 hours of life
- Home provision of Kangaroo Mother Care [14 days at home postpartum]
Number of participants providing any duration of skin-to-skin care on ≥10 of the first 14 days at home, among low birthweight or preterm infants
- Cord care [2-weeks postpartum]
Number of participants with no application of substances to cord
- Maternal knowledge of neonatal danger signs [6-weeks postpartum]
Number of danger signs or symptoms successfully named
- Appropriate care-seeking [6-weeks postpartum]
Number of clinic visits with danger sign and/ or hospital admissions reported in 1st 6 weeks
- Depression [Enrollment through 6-weeks postpartum]
Score above diagnostic threshold (>=13) for Edinburgh Postnatal Depression Scale. Possible scores are 0-30, with a higher score indicating a higher likelihood of possible depressive illness.
- Social support [Enrollment through 6-weeks postpartum]
Score using Medical Outcomes Study (MOS) Social Support Survey. Possible scores are 0-54, with a higher score indicating higher levels of social support.
- Self-efficacy [Enrollment through 6-weeks postpartum]
Score using a modified Karitane Parenting Confidence Scale. Possible scores are 0-63, with higher scores indicating higher levels of parenting confidence.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Pregnant
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28-36 weeks gestation
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Daily access to a mobile phone (own or shared) on the Safaricom network
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Willing to receive SMS
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Able to read and respond to text messages in English, Kiswahili or Luo, or have someone in the household who can help
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Plan to be in the area for at least five months postpartum
Exclusion Criteria:
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Currently enrolled in another research study
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Previous participant in the Mobile WACh NEO RCT (i.e. with a new pregnancy)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ahero Sub-District Hospital | Ahero | Kisumu | Kenya | |
| 2 | Bondo Sub-County Referral Hospital | Bondo | Kenya | ||
| 3 | Rachuonyo County Hospital | Homa Bay | Kenya | ||
| 4 | Kisumu County Hospital | Kisumu | Kenya | ||
| 5 | Mathare North Health Centre | Nairobi | Kenya | ||
| 6 | Riruta Health Center | Nairobi | Kenya |
Sponsors and Collaborators
- University of Washington
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Kenyatta National Hospital
- Women and Infants Hospital of Rhode Island
Investigators
- Principal Investigator: Jennifer A Unger, MD, MPH, Brown University
- Study Director: John Kinuthia, MBChB, MMed, Kenyatta National Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
- STUDY00006395
- 1R01HD098105-01