Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04598165
Other study ID # STUDY00006395
Secondary ID 1R01HD098105-01
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05777044 - The Effect of Hatha Yoga on Mental Health N/A
Recruiting NCT04977232 - Adjunctive Game Intervention for Anhedonia in MDD Patients N/A
Recruiting NCT04680611 - Severe Asthma, MepolizumaB and Affect: SAMBA Study
Recruiting NCT04043052 - Mobile Technologies and Post-stroke Depression N/A
Completed NCT04512768 - Treating Comorbid Insomnia in Transdiagnostic Internet-Delivered Cognitive Behaviour Therapy N/A
Recruiting NCT03207828 - Testing Interventions for Patients With Fibromyalgia and Depression N/A
Completed NCT04617015 - Defining and Treating Depression-related Asthma Early Phase 1
Recruiting NCT06011681 - The Rapid Diagnosis of MCI and Depression in Patients Ages 60 and Over
Completed NCT04476446 - An Expanded Access Protocol for Esketamine Treatment in Participants With Treatment Resistant Depression (TRD) Who do Not Have Other Treatment Alternatives Phase 3
Recruiting NCT02783430 - Evaluation of the Initial Prescription of Ketamine and Milnacipran in Depression in Patients With a Progressive Disease Phase 2/Phase 3
Recruiting NCT05563805 - Exploring Virtual Reality Adventure Training Exergaming N/A
Completed NCT03457714 - Guided Internet Delivered Cognitive-Behaviour Therapy for Persons With Spinal Cord Injury: A Feasibility Trial
Recruiting NCT05956912 - Implementing Group Metacognitive Therapy in Cardiac Rehabilitation Services (PATHWAY-Beacons)
Completed NCT05588622 - Meru Health Program for Cancer Patients With Depression and Anxiety N/A
Recruiting NCT05234476 - Behavioral Activation Plus Savoring for University Students N/A
Active, not recruiting NCT05006976 - A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study N/A
Enrolling by invitation NCT03276585 - Night in Japan Home Sleep Monitoring Study
Terminated NCT03275571 - HIV, Computerized Depression Therapy & Cognition N/A
Completed NCT03167372 - Pilot Comparison of N-of-1 Trials of Light Therapy N/A
Recruiting NCT05449002 - Digital Single Session Intervention for Youth Mental Health N/A