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Impact of a Smartphone Intervention on Tanzanian Women's Childbirth Location (SUSTAIN1)

Primary Purpose

Maternal Death Affecting Fetus or Newborn, Delivery Complication, Obstetric Complication

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
SUSTAIN Smartphone training of CHW (SP+)
SUSTAIN Paperbased training of CHW (SOC)
Sponsored by
University of Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Maternal Death Affecting Fetus or Newborn focused on measuring maternal health, community health, health services, Tanzania, evaluation, cluster randomized trial

Eligibility Criteria

16 Years - 49 Years (Child, Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • client of one of the CHWs enrolled in the mHealth study
  • visited at least once by a CHW following intervention (baseline training for CHWs) and during their most recent pregnancy
  • most recent delivery was a live birth and the child is still living

Exclusion Criteria:

  • None

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Control (paper based)

    Intervention (Smart phone assisted)

    Arm Description

    Women received prenatal household visits from CHWs who were trained on the Tanzania Ministry of Health and Social Welfare's National integrated Maternal, Newborn and Child Health (i-MNCH) paper-based protocols, i.e. received intervention "SUSTAIN Paperbased training of CHW (SOC)"

    Women received prenatal household visits from CHWs trained on the following: A) National i-MNCH programme; and B) Smartphone-assisted counseling protocol: a smartphone application designed to assist with identification of danger signs during pregnancy, referral to health facilities, and MNCH counseling , i.e. received intervention "SUSTAIN Smartphone training of CHW (SP+)"

    Outcomes

    Primary Outcome Measures

    Delivery in a facility
    Participant delivered at or on the way to a health facility, measured by retrospective report at time of interview, after delivery
    Antenatal care attendance
    Whether participant attended 4 ANC visits or more during their most recent pregnancy

    Secondary Outcome Measures

    Gestational age at first contact/ANC
    Number of months into pregnancy the participant had first ANC visit
    Iron supplementation during pregnancy
    Whether participant received 100 IFA tablets during pregnancy
    HIV screening HIV Screening
    Whether the participant was screened for HIV during pregnancy
    De-worming treatment during pregnancy
    Whether the participant reported during interview taking any listed de-worming medication during pregnancy
    Bednet use
    Whether the participant slept under an insecticide treated bed net during pregnancy
    Malaria prophylaxis during pregnancy
    Whether the participant reported during interview receiving two doses of IPTp during pregnancy
    Tetanus Toxoid Vaccination
    Whether the participant received two TT vaccinations during pregnancy
    Referrals
    Whether the participant was referred to a clinic during pregnancy by a CHW
    Referral uptake
    Whether a referred participant went to the facility during pregnancy
    Presence of partner at ANC
    Whether the participant's husband/spouse accompanied her to at least one ANC visit
    Birth plan
    Whether the participant developed a birth plan during pregnancy
    Early initiation of breastfeeding
    Whether the participant initiated breastfeeding within 1 hour after birth
    Exclusive breastfeeding at 7 days
    Whether the participant breastfed exclusively for the first week after birth
    BCG vaccination
    Whether the participant's child received BCG vaccination within the first week of life
    Maternal knowledge of danger signs during pregnancy
    Number of pregnancy danger signs listed by participant

    Full Information

    First Posted
    May 1, 2017
    Last Updated
    May 18, 2017
    Sponsor
    University of Toronto
    Collaborators
    World Vision, Muhimbili University of Health and Allied Sciences
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03161184
    Brief Title
    Impact of a Smartphone Intervention on Tanzanian Women's Childbirth Location
    Acronym
    SUSTAIN1
    Official Title
    Evaluation of an mHealth Intervention to Improve Women's Access to Maternal Health Services in Rural Tanzania
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    July 23, 2013 (Actual)
    Primary Completion Date
    June 25, 2014 (Actual)
    Study Completion Date
    June 25, 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Toronto
    Collaborators
    World Vision, Muhimbili University of Health and Allied Sciences

    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
    This study investigates whether training Community Health Workers (CHW) to use a smartphone-based prenatal counseling application as a "job aid" instead of the existing paper based standard is associated with increased women's use of maternal health services in Singida region, Tanzania.
    Detailed Description
    In low-income countries, frontline community health workers (CHWs) have potential to improve women's access to maternal health services through prenatal counseling and referral. However, CHW performance can often be enhanced with sufficient training, incentives, supportive supervision and job aids. Smartphone-based applications designed to assist CHWs with referrals, health education and client counseling may improve the quality of care delivered during household visits. There is a need for rigorous scientific studies on the impact of such interventions. This study investigates whether CHWs' use of a smartphone-based application increases women's use of maternal health services in Singida region, Tanzania. It is hypothesized that smartphone-assisted counselling by CHWs can increase use of health facility-based delivery services compared to a control group of CHWs using standard paper-based protocols. This study is conducted within the context of larger project - SUSTAIN-MNCH Project (Supporting Systems to Improve Nutrition, Maternal, Newborn and Child Health), implemented by World Vision through multiple partners.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Maternal Death Affecting Fetus or Newborn, Delivery Complication, Obstetric Complication, Birth Injuries, Delivery; Injury, Maternal, Delivery Problem for Fetus
    Keywords
    maternal health, community health, health services, Tanzania, evaluation, cluster randomized trial

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Participants assigned to one of two groups in parallel for the duration of the study
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    572 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Control (paper based)
    Arm Type
    Active Comparator
    Arm Description
    Women received prenatal household visits from CHWs who were trained on the Tanzania Ministry of Health and Social Welfare's National integrated Maternal, Newborn and Child Health (i-MNCH) paper-based protocols, i.e. received intervention "SUSTAIN Paperbased training of CHW (SOC)"
    Arm Title
    Intervention (Smart phone assisted)
    Arm Type
    Experimental
    Arm Description
    Women received prenatal household visits from CHWs trained on the following: A) National i-MNCH programme; and B) Smartphone-assisted counseling protocol: a smartphone application designed to assist with identification of danger signs during pregnancy, referral to health facilities, and MNCH counseling , i.e. received intervention "SUSTAIN Smartphone training of CHW (SP+)"
    Intervention Type
    Behavioral
    Intervention Name(s)
    SUSTAIN Smartphone training of CHW (SP+)
    Intervention Description
    Intervention (Smart phone assisted): During prenatal household visits, the smart phone based application guides CHW through electronic "decision tree" protocols, directing them to specific health/nutrition counseling topics and messages based on each woman's gestational age, and her answers to a specific series of diagnostic questions. Based on the client's gestational age, the tool directs CHW to lessons in an accompanying photo book, and reminds them to counsel on the importance of accessing timed and targeted maternal health services at health facilities. The application also assists CHW to identify danger signs during pregnancy, flags clients who require immediate referral to health facilities, and reminds CHW to follow-up with clients who were previously referred to clinics.
    Intervention Type
    Behavioral
    Intervention Name(s)
    SUSTAIN Paperbased training of CHW (SOC)
    Intervention Description
    SUSTAIN Paperbased training of CHW (SOC): During prenatal household visits, the CHW asks a specific series of diagnostic questions based on the client's gestational age, offers counsel on the importance of accessing appropriate maternal health services at health facilities and uses lessons in an accompanying photo book to deliver messages on a variety of maternal and newborn health and nutrition topics. CHW are trained to identify danger signs during pregnancy, flag clients who require immediate referral to health facilities, and follow-up with clients who were previously referred to clinics.
    Primary Outcome Measure Information:
    Title
    Delivery in a facility
    Description
    Participant delivered at or on the way to a health facility, measured by retrospective report at time of interview, after delivery
    Time Frame
    Time between the participant's first prenatal visit by a trained CHW and the date of the postnatal household interview (up to 10 months)
    Title
    Antenatal care attendance
    Description
    Whether participant attended 4 ANC visits or more during their most recent pregnancy
    Time Frame
    Time between the participant's first prenatal visit by a trained CHW and the date of the postnatal household interview (up to 10 months)
    Secondary Outcome Measure Information:
    Title
    Gestational age at first contact/ANC
    Description
    Number of months into pregnancy the participant had first ANC visit
    Time Frame
    Time between the participant's first prenatal visit by a trained CHW and the date of the postnatal household interview (up to 10 months)
    Title
    Iron supplementation during pregnancy
    Description
    Whether participant received 100 IFA tablets during pregnancy
    Time Frame
    Time between the participant's first prenatal visit by a trained CHW and the date of the postnatal household interview (up to 10 months)
    Title
    HIV screening HIV Screening
    Description
    Whether the participant was screened for HIV during pregnancy
    Time Frame
    Time between the participant's first prenatal visit by a trained CHW and the date of the postnatal household interview (up to 10 months)
    Title
    De-worming treatment during pregnancy
    Description
    Whether the participant reported during interview taking any listed de-worming medication during pregnancy
    Time Frame
    Time between the participant's first prenatal visit by a trained CHW and the date of the postnatal household interview (up to 10 months)
    Title
    Bednet use
    Description
    Whether the participant slept under an insecticide treated bed net during pregnancy
    Time Frame
    Time between the participant's first prenatal visit by a trained CHW and the date of the postnatal household interview (up to 10 months)
    Title
    Malaria prophylaxis during pregnancy
    Description
    Whether the participant reported during interview receiving two doses of IPTp during pregnancy
    Time Frame
    Time between the participant's first prenatal visit by a trained CHW and the date of the postnatal household interview (up to 10 months)
    Title
    Tetanus Toxoid Vaccination
    Description
    Whether the participant received two TT vaccinations during pregnancy
    Time Frame
    Time between the participant's first prenatal visit by a trained CHW and the date of the postnatal household interview (up to 10 months)
    Title
    Referrals
    Description
    Whether the participant was referred to a clinic during pregnancy by a CHW
    Time Frame
    Time between the participant's first prenatal visit by a trained CHW and the date of the postnatal household interview (up to 10 months)
    Title
    Referral uptake
    Description
    Whether a referred participant went to the facility during pregnancy
    Time Frame
    Time between the participant's first prenatal visit by a trained CHW and the date of the postnatal household interview (up to 10 months)
    Title
    Presence of partner at ANC
    Description
    Whether the participant's husband/spouse accompanied her to at least one ANC visit
    Time Frame
    Time between the participant's first prenatal visit by a trained CHW and the date of the postnatal household interview (up to 10 months)
    Title
    Birth plan
    Description
    Whether the participant developed a birth plan during pregnancy
    Time Frame
    Time between the participant's first prenatal visit by a trained CHW and the date of the postnatal household interview (up to 10 months)
    Title
    Early initiation of breastfeeding
    Description
    Whether the participant initiated breastfeeding within 1 hour after birth
    Time Frame
    Time between the participant's first prenatal visit by a trained CHW and the date of the postnatal household interview (up to 10 months)
    Title
    Exclusive breastfeeding at 7 days
    Description
    Whether the participant breastfed exclusively for the first week after birth
    Time Frame
    Time between the participant's first prenatal visit by a trained CHW and the date of the postnatal household interview (up to 10 months)
    Title
    BCG vaccination
    Description
    Whether the participant's child received BCG vaccination within the first week of life
    Time Frame
    Time between the participant's first prenatal visit by a trained CHW and the date of the postnatal household interview (up to 10 months)
    Title
    Maternal knowledge of danger signs during pregnancy
    Description
    Number of pregnancy danger signs listed by participant
    Time Frame
    Time between the participant's first prenatal visit by a trained CHW and the date of the postnatal household interview (up to 10 months)

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    Participant eligibility is based on self-representation of gender identity
    Minimum Age & Unit of Time
    16 Years
    Maximum Age & Unit of Time
    49 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: client of one of the CHWs enrolled in the mHealth study visited at least once by a CHW following intervention (baseline training for CHWs) and during their most recent pregnancy most recent delivery was a live birth and the child is still living Exclusion Criteria: None
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Daniel W Sellen, PhD
    Organizational Affiliation
    University of Toronto
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    Sharing raw data is inconsistent with what was stated in the ethics application form and participant informed consent materials.
    Citations:
    PubMed Identifier
    29912954
    Citation
    Hackett K, Lafleur C, Nyella P, Ginsburg O, Lou W, Sellen D. Impact of smartphone-assisted prenatal home visits on women's use of facility delivery: Results from a cluster-randomized trial in rural Tanzania. PLoS One. 2018 Jun 18;13(6):e0199400. doi: 10.1371/journal.pone.0199400. eCollection 2018.
    Results Reference
    derived

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    Impact of a Smartphone Intervention on Tanzanian Women's Childbirth Location

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