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Trial record 2 of 2257 for:    SUSTAIN 1

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT03161184
First Posted: May 19, 2017
Last Update Posted: May 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
World Vision
Muhimbili University of Health and Allied Sciences
Information provided by (Responsible Party):
Daniel Sellen, University of Toronto
  Purpose
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.

Condition Intervention
Maternal Death Affecting Fetus or Newborn Delivery Complication Obstetric Complication Birth Injuries Delivery; Injury, Maternal Delivery Problem for Fetus Behavioral: SUSTAIN Smartphone training of CHW (SP+) Behavioral: SUSTAIN Paperbased training of CHW (SOC)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Participants assigned to one of two groups in parallel for the duration of the study
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Evaluation of an mHealth Intervention to Improve Women's Access to Maternal Health Services in Rural Tanzania

Resource links provided by NLM:


Further study details as provided by Daniel Sellen, University of Toronto:

Primary Outcome Measures:
  • 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

  • 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


Secondary Outcome Measures:
  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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


Enrollment: 572
Actual Study Start Date: July 23, 2013
Study Completion Date: June 25, 2014
Primary Completion Date: June 25, 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 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.
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.

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   16 Years to 49 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Participant eligibility is based on self-representation of gender identity
Accepts Healthy Volunteers:   Yes
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:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03161184


Sponsors and Collaborators
University of Toronto
World Vision
Muhimbili University of Health and Allied Sciences
Investigators
Principal Investigator: Daniel W Sellen, PhD University of Toronto
  More Information

Responsible Party: Daniel Sellen, Professor, University of Toronto
ClinicalTrials.gov Identifier: NCT03161184     History of Changes
Other Study ID Numbers: 28832
First Submitted: May 1, 2017
First Posted: May 19, 2017
Last Update Posted: May 19, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Sharing raw data is inconsistent with what was stated in the ethics application form and participant informed consent materials.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Daniel Sellen, University of Toronto:
maternal health
community health
health services
Tanzania
evaluation
cluster randomized trial

Additional relevant MeSH terms:
Sulfamethazine
Wounds and Injuries
Maternal Death
Birth Injuries
Dystocia
Pregnancy Complications
Parental Death
Death
Pathologic Processes
Infant, Newborn, Diseases
Obstetric Labor Complications
Anti-Infective Agents