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Essential Coaching for Every Mother in Tanzania (ECEMTZ)

Primary Purpose

Self Efficacy, Postpartum Depression, Postpartum Anxiety

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Essential Coaching for Every Mother
Sponsored by
IWK Health Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Self Efficacy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Essential Coaching for Every Mother

    Standard Care

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Recruitment Effectiveness
    Number of participants enrolled versus approached. Number of participants per hospital site.
    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.
    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.
    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.

    Secondary Outcome Measures

    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.
    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).
    Breastfeeding Self-Efficacy
    Breastfeeding self-efficacy will be measured using the Breastfeeding Self-Efficacy Scale - Short Form. Higher scores indicate higher breastfeeding self-efficacy.
    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.
    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.
    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.
    Newborn mortality
    Data will be collected on newborn mortality (e.g., number of infant deaths during study).
    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.
    Postnatal Clinic Attendance
    Data will be collected on the number and date of postnatal contact.

    Full Information

    First Posted
    April 22, 2022
    Last Updated
    March 1, 2023
    Sponsor
    IWK Health Centre
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05362305
    Brief Title
    Essential Coaching for Every Mother in Tanzania
    Acronym
    ECEMTZ
    Official Title
    Essential Coaching for Every Mother: Developing and Evaluating a Text Message Postnatal Education Intervention for Mothers of Newborns in Tanzania
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 2023 (Anticipated)
    Primary Completion Date
    September 2024 (Anticipated)
    Study Completion Date
    January 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    IWK Health Centre

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Self Efficacy, Postpartum Depression, Postpartum Anxiety, Breastfeeding

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Care Provider
    Allocation
    Randomized
    Enrollment
    180 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Essential Coaching for Every Mother
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Standard Care
    Arm Type
    No Intervention
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Essential Coaching for Every Mother
    Intervention Description
    Daily text messages for the first six-weeks postpartum.
    Primary Outcome Measure Information:
    Title
    Recruitment Effectiveness
    Description
    Number of participants enrolled versus approached. Number of participants per hospital site.
    Time Frame
    Enrolment
    Title
    Implementation Dose
    Description
    Dose delivered - number of text messages sent. Output data available through the Africa's Talking and TextIt platforms will be collected per participant.
    Time Frame
    Enrolment and study completion (6 weeks)
    Title
    Implementation Engagement
    Description
    Un-subscription rates/drop out after enrolment. Output data available through the Africa's Talking and TextIt platforms will be collected per participant.
    Time Frame
    Enrolment and study completion (6 weeks)
    Title
    Implementation Quality
    Description
    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.
    Time Frame
    Six-weeks postpartum
    Secondary Outcome Measure Information:
    Title
    Newborn Care Knowledge
    Description
    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.
    Time Frame
    Baseline (enrolment), and six-weeks postpartum (follow-up)
    Title
    Maternal Self-Efficacy
    Description
    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).
    Time Frame
    Baseline (enrolment), and six-weeks postpartum (follow-up)
    Title
    Breastfeeding Self-Efficacy
    Description
    Breastfeeding self-efficacy will be measured using the Breastfeeding Self-Efficacy Scale - Short Form. Higher scores indicate higher breastfeeding self-efficacy.
    Time Frame
    Baseline (enrolment), and six-weeks postpartum (follow-up)
    Title
    Postpartum Depression
    Description
    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.
    Time Frame
    Baseline (enrolment), and six-weeks postpartum (follow-up)
    Title
    Postpartum Anxiety
    Description
    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.
    Time Frame
    Baseline (enrolment), and six-weeks postpartum (follow-up)
    Title
    Newborn morbidity
    Description
    Data will be collected on number of morbidities (e.g., diarrhea, jaundice, infection) identified per infant enrolled in the study within the 6-weeks.
    Time Frame
    Six-weeks postpartum (follow-up)
    Title
    Newborn mortality
    Description
    Data will be collected on newborn mortality (e.g., number of infant deaths during study).
    Time Frame
    Six-weeks postpartum (follow-up)
    Title
    Need for readmission
    Description
    Data will be collected on number of readmission to hospital for the infant and mothers during the six weeks and related reason.
    Time Frame
    Six-weeks postpartum (follow-up)
    Title
    Postnatal Clinic Attendance
    Description
    Data will be collected on the number and date of postnatal contact.
    Time Frame
    Six-weeks postpartum (follow-up)

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Justine Dol, PhD
    Phone
    000-000-0000
    Email
    justine.dol@dal.ca
    First Name & Middle Initial & Last Name or Official Title & Degree
    Marsha Campbell-Yeo, PhD
    Email
    marsha.campbell-yeo@dal.ca

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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