Depression, Neonatal Death, Perinatal Death
Conditions
Keywords
SMS, mHealth, neonate, mortality, depression, Kenya
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.
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.
Interventions
BEHAVIORALInteractive 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.
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Kenyatta National Hospital
Women and Infants Hospital of Rhode Island
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Participants will be randomized to 1) Interactive two-way SMS dialogue or 2) Control (no SMS), using 1:1 allocation.
Eligibility
Sex/Gender
FEMALE
Age
14 Years to No maximum
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neonatal Mortality | 28 days postpartum | Death during 1st 28 days of life |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Initiation of Early Breastfeeding | 1 hour postpartum | Number of participants initiating breastfeeding in 1st hour of life |
| Exclusive Breastfeeding | 6-weeks postpartum | Exclusive breastfeeding at 6-week visit |
| Thermal Care | 24 hours postpartum | Number of participants not giving infant a bath in 1st 24 hours of life |
| Cord Care | 2-weeks postpartum | Number of participants with no application of substances to cord |
| 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 |
| Early Neonatal Mortality | 7 days postpartum | Death during 1st 7 days of life |
| Appropriate Care-seeking | 18 weeks postpartum | 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). |
| Elevated Depressive Symptoms | 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 0-100, with a higher score indicating higher levels of social support. |
| Self-efficacy | Enrollment through 6-weeks postpartum | Score using the Karitane Parenting Confidence Scale. Possible scores are 0-45, with higher scores indicating higher levels of parenting confidence. |
| Maternal Knowledge of Neonatal Danger Signs | Up to 6-weeks postpartum | Number of danger signs or symptoms successfully named |
Countries
Kenya
Participant flow
Recruitment details
Pregnant women were recruited when attending routine antenatal care through referral to study staff. Those interested were asked to provide verbal consent for screening to assess eligibility, and if eligible, they were invited to participate in the study. Women were followed until 6 weeks postpartum but their infants were not considered enrolled. Infant outcomes were obtained from the participants and considered participant outcomes.
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 2,505 |
| No SMS Control Control receiving standard of care. | 2,508 |
| Total | 5,013 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Completed 6-week Follow-up | Death | 2 | 1 |
| Completed 6-week Follow-up | Ineligible | 4 | 3 |
| Completed 6-week Follow-up | Lost to Follow-up | 26 | 33 |
| Completed 6-week Follow-up | Partner refusal | 0 | 1 |
| Completed 6-week Follow-up | Withdrawal by Subject | 6 | 3 |
| Included in Intention to Treat Analysis | Ineligible for inclusion in analysis | 67 | 69 |
Baseline characteristics
| Characteristic | Total | Interactive Two-way SMS Dialogue | No SMS Control |
|---|---|---|---|
| <12 years of education | 2042 Participants | 1037 Participants | 1005 Participants |
| Age, Continuous | 25 years | 25 years | 25 years |
| Can read SMS unassisted | 5001 Participants | 2500 Participants | 2501 Participants |
| Can write SMS unassisted | 4993 Participants | 2492 Participants | 2501 Participants |
| Elevated depressive symptoms defined as a score ≥13 on Edinburgh Postnatal Depression Score (EPDS) | 159 Participants | 78 Participants | 81 Participants |
| Employed | 1864 Participants | 943 Participants | 921 Participants |
| Enrollment clinic Facility 1 | 369 Participants | 185 Participants | 184 Participants |
| Enrollment clinic Facility 2 | 961 Participants | 480 Participants | 481 Participants |
| Enrollment clinic Facility 3 | 394 Participants | 197 Participants | 197 Participants |
| Enrollment clinic Facility 4 | 1538 Participants | 766 Participants | 772 Participants |
| Enrollment clinic Facility 5 | 917 Participants | 458 Participants | 459 Participants |
| Enrollment clinic Facility 6 | 834 Participants | 419 Participants | 415 Participants |
| Estimated gestational age in weeks at baseline | 31.6 weeks | 31.6 weeks | 31.4 weeks |
| HIV positive | 426 Participants | 218 Participants | 208 Participants |
| Household crowding (>3 people per room) | 770 Participants | 399 Participants | 371 Participants |
| Intimate partner violence in last month | 189 Participants | 91 Participants | 98 Participants |
| Married/cohabitating | 4050 Participants | 2000 Participants | 2050 Participants |
| Parenting self-efficacy using the Karitane Parenting Confidence Scale (KPCS) | 45 units on a scale from 0-45 | 45 units on a scale from 0-45 | 45 units on a scale from 0-45 |
| Primigravida | 1692 Participants | 864 Participants | 828 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 5013 Participants | 2505 Participants | 2508 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Received health SMS messages from another program | 1212 Participants | 635 Participants | 577 Participants |
| Region of Enrollment Kenya | 5013 participants | 2505 participants | 2508 participants |
| Self-reported social support score using the MOS social support survey | 81.6 units on a scale from 0-100 | 80.3 units on a scale from 0-100 | 82.9 units on a scale from 0-100 |
| Sex: Female, Male Female | 5013 Participants | 2505 Participants | 2508 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Shares mobile phone | 539 Participants | 299 Participants | 240 Participants |
| Twins | 81 Participants | 42 Participants | 39 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 2,505 | 2 / 2,508 |
| other Total, other adverse events | 7 / 2,505 | 2 / 2,508 |
| serious Total, serious adverse events | 171 / 2,505 | 114 / 2,508 |
Outcome results
Primary
Neonatal Mortality
Death during 1st 28 days of life
Time frame: 28 days postpartum
Population: Intention-to-treat for participants with a known infant outcome at 6 weeks postpartum. Seventy-two (72) participants excluded from the Overall Number of Participants Analyzed, due to stillbirth.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Interactive Two-way SMS Dialogue | Neonatal Mortality | 46 Participants |
| No SMS Control | Neonatal Mortality | 37 Participants |
Comparison: We estimated a sample size of 5000 to detect a risk ratio of ≤0.53 assuming a neonatal mortality rate of 23 per 1000 in the control arm with 80% power and, 95% confidence and taking into account a 10% attrition. Multiple imputation with chain equations (MICE) was used to impute missing values for any outcome with greater than 10% missingness. Any variables associated with the outcome or outcome missingness were included in the imputation model.p-value: 0.31495% CI: [0.81, 1.92]Poisson regression
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).
Time frame: 18 weeks postpartum
Population: Only in infants with illness episodes with danger signs and/or where the infant was hospitalized irrespective of danger signs reported.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Interactive Two-way SMS Dialogue | Appropriate Care-seeking | 204 Participants |
| No SMS Control | Appropriate Care-seeking | 160 Participants |
Comparison: We estimated a sample size of 5000 to detect a risk ratio of ≤0.53 assuming a neonatal mortality rate of 23 per 1000 in the control arm with 80% power and, 95% confidence and assuming 10% attrition. With this sample size, assuming alpha=0.0045 (Bonferroni adjusted for 11 tests), we also had 80% power to detect a risk ratio of 1.11 in appropriate care seeking assuming 1 clinic visit in the 6-weeks postpartum for controls.p-value: 0.32195% CI: [0.98, 1.08]Poisson regression
Secondary
Cord Care
Number of participants with no application of substances to cord
Time frame: 2-weeks postpartum
Population: This population includes participants who did not experience a stillbirth or infant death by 2 weeks postpartum, those who did not decline to answer and those for whom data was not missing.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Interactive Two-way SMS Dialogue | Cord Care | 1123 Participants |
| No SMS Control | Cord Care | 1104 Participants |
Comparison: We estimated a sample size of 5000 to detect a risk ratio of ≤0.53 assuming a neonatal mortality rate of 23 per 1000 in the control arm with 80% power and, 95% confidence and assuming 10% attrition. With this sample size, assuming alpha=0.0045 (Bonferroni adjusted for 11 tests), we also had 80% power to detect a risk ratio of 1.11 in application of substances to the cord or delaying first bath assuming 50% in controls.p-value: 0.35395% CI: [0.97, 1.09]Poisson regression
Secondary
Early Neonatal Mortality
Death during 1st 7 days of life
Time frame: 7 days postpartum
Population: Intention-to-treat for participants with a known infant outcome at the 7th day of life. Seventy-two (72) stillbirths were removed from analysis cohort. This includes 13 participants for whom an outcome is not known at 6 weeks of life for the primary outcome. Seventy-two (72) stillbirths were removed from analysis cohort.Seventy-two (72) participants excluded from the Overall Number of Participants Analyzed, due to stillbirth.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Interactive Two-way SMS Dialogue | Early Neonatal Mortality | 38 Participants |
| No SMS Control | Early Neonatal Mortality | 28 Participants |
Comparison: We estimated a sample size of 5000 to detect a risk ratio of ≤0.53 assuming a neonatal mortality rate of 23 per 1000 in the control arm with 80% power and, 95% confidence and taking into account a 10% attrition. Multiple imputation with chain equations (MICE) was used to impute missing values for any outcome with greater than 10% missingness. Any variables associated with the outcome or outcome missingness were included in the imputation model.p-value: 0.21795% CI: [0.84, 2.21]Poisson regression
Secondary
Elevated Depressive Symptoms
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.
Time frame: Enrollment through 6-weeks postpartum
Population: This population includes participants who attended the 6 week visit, those who did not decline to answer and those for whom data was not missing.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Interactive Two-way SMS Dialogue | Elevated Depressive Symptoms | 38 Participants |
| No SMS Control | Elevated Depressive Symptoms | 40 Participants |
Comparison: We estimated a sample size of 5000 to detect a risk ratio of ≤0.53 assuming a neonatal mortality rate of 23 per 1000 in the control arm with 80% power and, 95% confidence and assuming 10% attrition. With this sample size, assuming alpha=0.0045 (Bonferroni adjusted for 11 tests), we also had 80% power to detect a risk ratio of 0.76 in elevated depression symptoms assuming 19% in controls.p-value: 0.6595% CI: [0.98, 1.04]Poisson generalized estimating equations
Secondary
Exclusive Breastfeeding
Exclusive breastfeeding at 6-week visit
Time frame: 6-weeks postpartum
Population: This population includes participants who did not experience a stillbirth or infant death by 6 weeks postpartum, who attended the 6 week follow-up visit, who did not decline to answer and those for whom data was not missing.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Interactive Two-way SMS Dialogue | Exclusive Breastfeeding | 2190 Participants |
| No SMS Control | Exclusive Breastfeeding | 2217 Participants |
Comparison: We estimated a sample size of 5000 to detect a risk ratio of ≤0.53 assuming a neonatal mortality rate of 23 per 1000 in the control arm with 80% power and, 95% confidence and assuming 10% attrition. With this sample size, assuming alpha=0.0045 (Bonferroni adjusted for 11 tests), we also had 80% power to detect a risk ratio of 1.05 in exclusive breast feeding assuming 80% uptake in controls.p-value: 0.36395% CI: [0.98, 1.01]Poisson regression
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
Time frame: 14 days at home postpartum
Population: Only among preterm and/or low birth weight live births.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Interactive Two-way SMS Dialogue | Home Provision of Kangaroo Mother Care | 12 Participants |
| No SMS Control | Home Provision of Kangaroo Mother Care | 10 Participants |
Comparison: We estimated a sample size of 5000 to detect a risk ratio of ≤0.53 assuming a neonatal mortality rate of 23 per 1000 in the control arm with 80% power and, 95% confidence and assuming 10% attrition. With this sample size, assuming alpha=0.0045 (Bonferroni adjusted for 11 tests), we also had 80% power to detect a risk ratio of 1.53 in provision of Kangaroo Mother Care assuming 25% in controls.p-value: 0.75195% CI: [0.5, 2.61]Poisson regression
Secondary
Initiation of Early Breastfeeding
Number of participants initiating breastfeeding in 1st hour of life
Time frame: 1 hour postpartum
Population: This population includes participants who did not experience a stillbirth or infant death by 2 weeks postpartum, who attended the 2 week follow-up visit, who did not decline to answer and those for whom data was not missing.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Interactive Two-way SMS Dialogue | Initiation of Early Breastfeeding | 1510 Participants |
| No SMS Control | Initiation of Early Breastfeeding | 1402 Participants |
Comparison: We estimated a sample size of 5000 to detect a risk ratio of ≤0.53 assuming a neonatal mortality rate of 23 per 1000 in the control arm with 80% power and, 95% confidence and assuming 10% attrition. With this sample size, assuming alpha=0.0045 (Bonferroni adjusted for 11 tests), we also had 80% power to detect a risk ratio of 1.05 in early initiation of breast feeding assuming 80% uptake in controls.p-value: 0.06495% CI: [1, 1.08]Poisson regression
Secondary
Maternal Knowledge of Neonatal Danger Signs
Number of danger signs or symptoms successfully named
Time frame: Up to 6-weeks postpartum
Population: For this time-varying outcome, data for the 6-week visit are presented here. This population includes those who did not decline to answer and those for whom data was not missing. Data are missing for those experienced an infant loss by the 6-week visit.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Interactive Two-way SMS Dialogue | Maternal Knowledge of Neonatal Danger Signs | 3 Number of danger signs named |
| No SMS Control | Maternal Knowledge of Neonatal Danger Signs | 2 Number of danger signs named |
Comparison: We estimated a sample size of 5000 to detect a risk ratio of ≤0.53 assuming a neonatal mortality rate of 23 per 1000 in the control arm with 80% power and, 95% confidence and assuming 10% attrition. With this sample size, assuming alpha=0.0045 (Bonferroni adjusted for 11 tests), we also had 80% power to detect a risk ratio of 1.04 in number of danger signs correctly named assuming median of 3 in controls.p-value: 0.43195% CI: [1, 1.01]Poisson generalized estimating equations
Secondary
Self-efficacy
Score using the Karitane Parenting Confidence Scale. Possible scores are 0-45, with higher scores indicating higher levels of parenting confidence.
Time frame: Enrollment through 6-weeks postpartum
Population: For this time-varying outcome, data for the 6-week visit are presented here. This population includes those who did not decline to answer and those for whom data was not missing.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Interactive Two-way SMS Dialogue | Self-efficacy | 45 score on a scale |
| No SMS Control | Self-efficacy | 45 score on a scale |
p-value: 0.1995% CI: [-0.01, 0.04]Linear generalized estimating equations
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.
Time frame: Enrollment through 6-weeks postpartum
Population: For this time-varying outcome, data for the 6-week visit are presented here. This population includes those who did not decline to answer and those for whom data was not missing.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Interactive Two-way SMS Dialogue | Social Support | 84.2 score on a scale |
| No SMS Control | Social Support | 84.2 score on a scale |
p-value: 0.07195% CI: [-0.007, 0.18]Linear generalized estimating equations
Secondary
Thermal Care
Number of participants not giving infant a bath in 1st 24 hours of life
Time frame: 24 hours postpartum
Population: This population includes participants who did not experience a stillbirth or infant death by 2 weeks postpartum, whose infants did not die on the first day of life, who did not decline to answer and those for whom data was not missing.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Interactive Two-way SMS Dialogue | Thermal Care | 2245 Participants |
| No SMS Control | Thermal Care | 2232 Participants |
Comparison: We estimated a sample size of 5000 to detect a risk ratio of ≤0.53 assuming a neonatal mortality rate of 23 per 1000 in the control arm with 80% power and, 95% confidence and assuming 10% attrition. With this sample size, assuming alpha=0.0045 (Bonferroni adjusted for 11 tests), we also had 80% power to detect a risk ratio of 1.11 in application of substances to the cord or delaying first bath assuming 50% in controls.p-value: 0.09395% CI: [1, 1.02]Poisson regression