Essential Coaching for Every Mother in Tanzania

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate a text message intervention called Essential Coaching for Every Mother in Tanzania to improve mothers' access to essential newborn care information during the immediate six-week postnatal period.

Detailed Description
-----------------
This is a 2-group parallel arm randomized controlled trial. Participants will be randomized into either the intervention or a control group. No changes to in-person care will occur. This study will be conducted in Dar es Salaam, Tanzania with mothers recruited from a Tanzanian postnatal ward who have recently given birth at four different hospitals. Participants in the intervention group will start receiving the Essential Coaching for Every Mother program based on their delivery date up to six weeks postpartum. Mothers in the control group will not receive any text messages. Both groups will be asked to complete an survey at enrolment and six-weeks postpartum. The investigators aim to recruitment 180 participants in total, 90 per group.

Official Title
-----------------
Essential Coaching for Every Mother: Developing and Evaluating a Text Message Postnatal Education Intervention for Mothers of Newborns in Tanzania

Conditions
-----------------
Self Efficacy, Postpartum Depression, Postpartum Anxiety, Breastfeeding

Intervention / Treatment
-----------------
* Behavioral: Essential Coaching for Every Mother


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: have recently given birth within the hospital have daily access to a mobile phone with text message capabilities are over 18 years of age speak and read English or Swahili. Exclusion Criteria: newborns die or are expected to die prior to leaving the hospital they have no access to mobile phone, either personal or shared unwilling to receive text messages decline to participate are experiencing major postnatal complications expected to impact learning or ability to consent while in the hospital (e.g., postpartum hemorrhage, seizures) participated in Phase I of this project.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Essential Coaching for Every Mother<br>Mothers in the intervention group will receive in-hospital education by a non-study nurse midwife while on the postnatal ward prior to discharge as per standard protocol on the unit. On the third day after birth, mothers will receive daily text messages to 6 weeks postpartum. The messages will be sent automatically each day based on the date of birth of the infant. | Behavioral: Essential Coaching for Every Mother<br>* Daily text messages for the first six-weeks postpartum.<br>|
| No Intervention: Standard Care<br>Mothers will receive in-person education provided by a non-study nurse midwife while on the postnatal ward prior to discharge as per current standard protocol on the unit. Mothers in this group will not receive any further text messages from the program. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment Effectiveness | Number of participants enrolled versus approached. Number of participants per hospital site. | Enrolment | 
| Implementation Dose | Dose delivered - number of text messages sent. Output data available through the Africa's Talking and TextIt platforms will be collected per participant. | Enrolment and study completion (6 weeks) | 
| Implementation Engagement | Un-subscription rates/drop out after enrolment. Output data available through the Africa's Talking and TextIt platforms will be collected per participant. | Enrolment and study completion (6 weeks) | 
| Implementation Quality | Mothers in the intervention group will be asked about the number of messages they recall receiving, user experience, perspectives on the frequency and timing of messages, and what did they like and not like about Essential Coaching for Every Mother. | Six-weeks postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Newborn Care Knowledge | Knowledge will be assessed using a modified questionnaire developed by McConnell and colleagues. Questions will determine whether mothers can identify danger signs, hand washing practices, cord care, newborn thermal care, and breastfeeding. A summative score will be created with a maximum of five points and a minimum of zero, where each point represents knowledge on the above postnatal health topics. | Baseline (enrolment), and six-weeks postpartum (follow-up) | 
| Maternal Self-Efficacy | Parenting self-efficacy will be measured using the Karitane Parenting Confidence Scale (KPCS) tool. This 15-item tool was developed to assess perceived self-efficacy of mothers of newborns birth to twelve months of age. A cut off score of 39 or less (out of a possible 45) was determine to be a clinically low perceived parenting self-efficacy (PPSE). | Baseline (enrolment), and six-weeks postpartum (follow-up) | 
| Breastfeeding Self-Efficacy | Breastfeeding self-efficacy will be measured using the Breastfeeding Self-Efficacy Scale - Short Form. Higher scores indicate higher breastfeeding self-efficacy. | Baseline (enrolment), and six-weeks postpartum (follow-up) | 
| Postpartum Depression | Depression will be measured using the Edinburgh Postnatal Depression Scale (EPDS). The EPDS is a self-report screening scale with 10 items that can indicate if a respondent has symptoms related to perinatal depression with a score >12 considered high symptoms of depression. | Baseline (enrolment), and six-weeks postpartum (follow-up) | 
| Postpartum Anxiety | Anxiety will be measured using the Generalized Anxiety Disorder (GAD)-7, which is a 7-item scale used to assess generalized anxiety disorder. The scale ranges between 0 and 21, with scores of 10 or greater indicative of generalized anxiety at a moderate/severe level. | Baseline (enrolment), and six-weeks postpartum (follow-up) | 
| Newborn morbidity | Data will be collected on number of morbidities (e.g., diarrhea, jaundice, infection) identified per infant enrolled in the study within the 6-weeks. | Six-weeks postpartum (follow-up) | 
| Newborn mortality | Data will be collected on newborn mortality (e.g., number of infant deaths during study). | Six-weeks postpartum (follow-up) | 
| Need for readmission | Data will be collected on number of readmission to hospital for the infant and mothers during the six weeks and related reason. | Six-weeks postpartum (follow-up) | 
| Postnatal Clinic Attendance | Data will be collected on the number and date of postnatal contact. | Six-weeks postpartum (follow-up) |