Maternal Death Affecting Fetus or NewbornSUSTAIN1NCT03161184

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

A study testing SUSTAIN Smartphone training of CHW (SP+) and SUSTAIN Paperbased training of CHW (SOC) in people with Maternal Death Affecting Fetus or Newborn and Delivery Complication, run by University of Toronto.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 16 to 49 years, women onlyHealthy volunteers can take part
Conditions the study is for: Maternal Death Affecting Fetus or Newborn, Delivery Complication, Obstetric Complication
What is being tested?: SUSTAIN Smartphone training of CHW (SP+) and SUSTAIN Paperbased training of CHW (SOC)
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 572 participants
Where: No sites listed yet
Study dates: 23 Jul 2013to 25 Jun 2014
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 16 to 49 years
Women only
Healthy volunteers accepted
Child, Adult

Who may be able to join

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

Who cannot join

None

About this study

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

Read the 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.

Conditions: Maternal Death Affecting Fetus or Newborn, Delivery Complication, Obstetric Complication, Birth Injuries, Delivery; Injury, Maternal, Delivery Problem for Fetus
Being tested: SUSTAIN Smartphone training of CHW (SP+), SUSTAIN Paperbased training of CHW (SOC)
Keywords: maternal health, community health, health services, Tanzania, evaluation, cluster randomized trial
Medical subject headings: Birth Injuries, Wounds and Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SUSTAIN Smartphone training of CHW (SP+)Behavioural
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.
SUSTAIN Paperbased training of CHW (SOC)Behavioural
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.

Study groups in NCT03161184
Study group	Role	What they receive
Control (paper based)	Active comparator	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)" Receives: Behavioral: SUSTAIN Paperbased training of CHW (SOC)
Intervention (Smart phone assisted)	Experimental	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+)" Receives: Behavioral: SUSTAIN Smartphone training of CHW (SP+); Behavioral: SUSTAIN Paperbased training of CHW (SOC)

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
Whether participant attended 4 ANC visits or more during their most recent pregnancy
Measured: 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 outcomes (15)

Gestational age at first contact/ANC
Number of months into pregnancy the participant had first ANC visit
Measured: 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
Whether participant received 100 IFA tablets during pregnancy
Measured: 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
Whether the participant was screened for HIV during pregnancy
Measured: 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
Whether the participant reported during interview taking any listed de-worming medication during pregnancy
Measured: 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
Whether the participant slept under an insecticide treated bed net during pregnancy
Measured: 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
Whether the participant reported during interview receiving two doses of IPTp during pregnancy
Measured: 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
Whether the participant received two TT vaccinations during pregnancy
Measured: 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
Whether the participant was referred to a clinic during pregnancy by a CHW
Measured: 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
Whether a referred participant went to the facility during pregnancy
Measured: 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
Whether the participant's husband/spouse accompanied her to at least one ANC visit
Measured: 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
Whether the participant developed a birth plan during pregnancy
Measured: 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
Whether the participant initiated breastfeeding within 1 hour after birth
Measured: 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
Whether the participant breastfed exclusively for the first week after birth
Measured: 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
Whether the participant's child received BCG vaccination within the first week of life
Measured: 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
Number of pregnancy danger signs listed by participant
Measured: Time between the participant's first prenatal visit by a trained CHW and the date of the postnatal household interview (up to 10 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Jul 201325 Jun 2014

First posted19 May 2017
Study start23 Jul 2013
Primary completion25 Jun 2014
Study completion25 Jun 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Maternal Death Affecting Fetus or NewbornStudies of the same condition, open and under way.
More trials run by University of TorontoThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Model description: Participants assigned to one of two groups in parallel for the duration of the study
Masking: None (open label)
Enrolment: 572 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03161184
Sponsor's protocol ID: 28832
Acronym: SUSTAIN1
Status last verified: May 2017
First submitted: 1 May 2017
Last updated: 19 May 2017
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Sharing raw data is inconsistent with what was stated in the ethics application form and participant informed consent materials.

Publications

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.
PubMed 29912954

Study at a glance

From the registry record, last updated by the sponsor on 19 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of an mHealth Intervention to Improve Women's Access to Maternal Health Services in Rural Tanzania
ClinicalTrials.gov ID: NCT03161184
Acronym / sponsor ID: SUSTAIN1 / 28832
Conditions: 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
Study type: Interventional
Recruitment status: Completed
Enrolment: 572 participants (actual)
Lead sponsor: University of TorontoUniversity, hospital or other
Collaborators: World Vision, Muhimbili University of Health and Allied Sciences
Study start: 23 Jul 2013 (actual)
Primary completion: 25 Jun 2014 (actual)
Study completion: 25 Jun 2014 (actual)
First posted: 19 May 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Participants assigned to one of two groups in parallel for the duration of the study

Arm	Type	Receives
Control (paper based)	Active comparator	Behavioral: SUSTAIN Paperbased training of CHW (SOC)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)"
Intervention (Smart phone assisted)	Experimental	Behavioral: SUSTAIN Smartphone training of CHW (SP+), Behavioral: 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+)"

Who may qualify

Ages: 16 to 49 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (1 listed)

None

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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.	Behavioural	Intervention (Smart phone assisted)
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.	Behavioural	Control (paper based), Intervention (Smart phone assisted)

Primary outcome

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

15 secondary outcomes

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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2017.
Derived from this study: PubMed 29912954Hackett 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.
Individual participant dataSharing planned: No. Sharing raw data is inconsistent with what was stated in the ethics application form and participant informed consent materials.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Daniel W Sellen, PhD principal investigator

University of Toronto

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 May 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03161184, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2017; AzTrials last refreshed its copy on 8 Nov 2026.