Mobile WACh NEO: Mobile Solutions for Neonatal Health and Maternal Support

Depression Clinical Trial

Official title:

Mobile WACh NEO Randomized Clinical Trial: Mobile Phone 2-Way Short Message Service (SMS) Versus Control to Reduce Neonatal Mortality in Kenya

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04598165
• Other study ID #: STUDY00006395
• Secondary ID: 1R01HD098105-01
• Status: Completed
• Phase: N/A
• Start date: September 7, 2020
• Est. completion date: February 20, 2023

Study information

• Verified date: January 2024
• Source: Women and Infants Hospital of Rhode Island
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5020
• Est. completion date: February 20, 2023
• Est. primary completion date: February 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 14 Years and older

Eligibility

Inclusion Criteria:

• Pregnant
• 28-36 weeks gestation
• Daily access to a mobile phone (own or shared) on the Safaricom network
• Willing to receive SMS
• 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
• Previous participant in the Mobile WACh NEO RCT (i.e. with a new pregnancy)

Related Conditions & MeSH terms

• Death
• Depression
• Neonatal Death
• Perinatal Death

Intervention

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.

Locations

Country	Name	City	State
Kenya	Ahero Sub-District Hospital	Ahero	Kisumu
Kenya	Bondo Sub-County Referral Hospital	Bondo
Kenya	Rachuonyo County Hospital	Homa Bay
Kenya	Kisumu County Hospital	Kisumu
Kenya	Mathare North Health Centre	Nairobi
Kenya	Riruta Health Center	Nairobi

Sponsors (3)

Lead Sponsor	Collaborator
Women and Infants Hospital of Rhode Island	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Kenyatta National Hospital

Country where clinical trial is conducted

Kenya, 

References & Publications (1)

Ronen K, Choo EM, Wandika B, Udren JI, Osborn L, Kithao P, Hedstrom AB, Masinde M, Kumar M, Wamalwa DC, Richardson BA, Kinuthia J, Unger JA. Evaluation of a two-way SMS messaging strategy to reduce neonatal mortality: rationale, design and methods of the Mobile WACh NEO randomised controlled trial in Kenya. BMJ Open. 2021 Dec 23;11(12):e056062. doi: 10.1136/bmjopen-2021-056062. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neonatal mortality	Death during 1st 28 days of life	28 days postpartum
Secondary	Early neonatal mortality	Death during 1st 7 days of life	7 days postpartum
Secondary	Initiation of early breastfeeding	Number of participants initiating breastfeeding in 1st hour of life	1 hour postpartum
Secondary	Exclusive breastfeeding	Cessation of exclusive breastfeeding in 1st 6 weeks of life	6-weeks postpartum
Secondary	Thermal care	Number of participants giving infant a bath in 1st 24 hours of life	24 hours postpartum
Secondary	Home provision of Kangaroo Mother Care	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	14 days at home postpartum
Secondary	Cord care	Number of participants with no application of substances to cord	2-weeks postpartum
Secondary	Maternal knowledge of neonatal danger signs	Number of danger signs or symptoms successfully named	6-weeks postpartum
Secondary	Appropriate care-seeking	Proportion of illness episodes with danger signs in which the clinic was attended and/or where the infant was hospitalized irrespective of danger signs reported in 1st 18 weeks of life (study follow-up period).	18 weeks postpartum
Secondary	Depression	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.	Enrollment through 6-weeks postpartum
Secondary	Social support	Score using Medical Outcomes Study (MOS) Social Support Survey. Possible scores are 0-100, with a higher score indicating higher levels of social support.	Enrollment through 6-weeks postpartum
Secondary	Self-efficacy	Score using the Karitane Parenting Confidence Scale. Possible scores are 0-45, with higher scores indicating higher levels of parenting confidence.	Enrollment through 6-weeks postpartum