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

May 18, 2017 updated by: Daniel Sellen, University of Toronto

Evaluation of an mHealth Intervention to Improve Women's Access to Maternal Health Services in Rural Tanzania

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
572

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

16 years to 49 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Control (paper based)
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)"
Behavioral: SUSTAIN Paperbased training of CHW (SOC)
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.
Experimental: Intervention (Smart phone assisted)

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+)"
Behavioral: SUSTAIN Paperbased training of CHW (SOC)
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.
Behavioral: SUSTAIN Smartphone training of CHW (SP+)
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Delivery in a facility
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)
Participant delivered at or on the way to a health facility, measured by retrospective report at time of interview, after delivery
Time between the participant's first prenatal visit by a trained CHW and the date of the postnatal household interview (up to 10 months)
Antenatal care attendance
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)
Whether participant attended 4 ANC visits or more during their most recent pregnancy
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 Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Gestational age at first contact/ANC
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)
Number of months into pregnancy the participant had first ANC visit
Time between the participant's first prenatal visit by a trained CHW and the date of the postnatal household interview (up to 10 months)
Iron supplementation 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)
Whether participant received 100 IFA tablets during pregnancy
Time between the participant's first prenatal visit by a trained CHW and the date of the postnatal household interview (up to 10 months)
HIV screening HIV Screening
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)
Whether the participant was screened for HIV during pregnancy
Time between the participant's first prenatal visit by a trained CHW and the date of the postnatal household interview (up to 10 months)
De-worming treatment 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)
Whether the participant reported during interview taking any listed de-worming medication during pregnancy
Time between the participant's first prenatal visit by a trained CHW and the date of the postnatal household interview (up to 10 months)
Bednet use
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)
Whether the participant slept under an insecticide treated bed net during pregnancy
Time between the participant's first prenatal visit by a trained CHW and the date of the postnatal household interview (up to 10 months)
Malaria prophylaxis 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)
Whether the participant reported during interview receiving two doses of IPTp during pregnancy
Time between the participant's first prenatal visit by a trained CHW and the date of the postnatal household interview (up to 10 months)
Tetanus Toxoid Vaccination
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)
Whether the participant received two TT vaccinations during pregnancy
Time between the participant's first prenatal visit by a trained CHW and the date of the postnatal household interview (up to 10 months)
Referrals
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)
Whether the participant was referred to a clinic during pregnancy by a CHW
Time between the participant's first prenatal visit by a trained CHW and the date of the postnatal household interview (up to 10 months)
Referral uptake
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)
Whether a referred participant went to the facility during pregnancy
Time between the participant's first prenatal visit by a trained CHW and the date of the postnatal household interview (up to 10 months)
Presence of partner at ANC
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)
Whether the participant's husband/spouse accompanied her to at least one ANC visit
Time between the participant's first prenatal visit by a trained CHW and the date of the postnatal household interview (up to 10 months)
Birth plan
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)
Whether the participant developed a birth plan during pregnancy
Time between the participant's first prenatal visit by a trained CHW and the date of the postnatal household interview (up to 10 months)
Early initiation of breastfeeding
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)
Whether the participant initiated breastfeeding within 1 hour after birth
Time between the participant's first prenatal visit by a trained CHW and the date of the postnatal household interview (up to 10 months)
Exclusive breastfeeding at 7 days
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)
Whether the participant breastfed exclusively for the first week after birth
Time between the participant's first prenatal visit by a trained CHW and the date of the postnatal household interview (up to 10 months)
BCG vaccination
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)
Whether the participant's child received BCG vaccination within the first week of life
Time between the participant's first prenatal visit by a trained CHW and the date of the postnatal household interview (up to 10 months)
Maternal knowledge of danger signs 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)
Number of pregnancy danger signs listed by participant
Time between the participant's first prenatal visit by a trained CHW and the date of the postnatal household interview (up to 10 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Toronto

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
World Vision
Muhimbili University of Health and Allied Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Daniel W Sellen, PhD, University of Toronto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 23, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 25, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 25, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 1, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 18, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 19, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 19, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 18, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 28832

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Sharing raw data is inconsistent with what was stated in the ethics application form and participant informed consent materials.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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