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Development of a Mobile Application for HBB Prompt Study

Development of a Mobile Application Through User Centered Design to Improve Helping Babies Breath Skills Retention

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03577054
Acronym
HBB-Prompt
Enrollment
20
Registered
2018-07-05
Start date
2018-05-14
Completion date
2019-06-30
Last updated
2018-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Birth Asphyxia, Neonatal Death

Keywords

Helping Babies Breathe, newborn resuscitation, skills retention, mobile health, user-centred design

Brief summary

This study applies an iterative user-centred design approach involving frontline birth attendants to create a mobile application (HBB Prompt) to improve skills retention after initial newborn stabilization training through the Helping Babies Breathe (HBB) program. HBB Prompt will then be piloted at one site after HBB training and skills retention will be compared with a control site without HBB Prompt after HBB training.

Detailed description

Helping Babies Breathe (HBB) is a newborn stabilization course that has been shown to reduce neonatal mortality by up to 47%. Such mortality impact is however not sustained due to rapid skills deterioration. The investigators propose to improve sustainability of HBB's impact by increasing skills retention with an innovative mobile application called HBB Prompt. HBB Prompt will be an interactive tool that guides frontline providers through the steps needed to save newborn babies at birth. HBB Prompt will facilitate individual and group training in health facilities using the Low Dose High Frequency model (LDHF) for resuscitation skills retention. The investigators will robustly develop HBB Prompt by integrating human factors and user-centered design approaches. The investigators will engage end-users and HBB Master Trainers to iteratively collect feedback to develop HBB Prompt for both individual and small group resuscitation practice. The iterative approach will mitigate the common scenario of mobile health (mHealth) solutions unable to achieve sustained success at scale due to lack of comprehensive input from frontline users. The investigators will pilot the app at a single centre and compare it to a control site for HBB skills retention at different time points after initial HBB training.

Interventions

BEHAVIORALHBB Prompt

Mobile app developed through user-centred design in phase 1 of this study

BEHAVIORALLow-Dose High Frequency training

Participants will be encouraged to practice their HBB skills daily

Sponsors

The Hospital for Sick Children
CollaboratorOTHER
Mbarara University of Science and Technology
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)

Masking description

Outcomes assessor at analysis stage will be masked to allocation of participants

Intervention model description

Parallel Assignment

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* Frontline birth attendants involved in the delivery or care of babies in the maternity ward, theater or pediatric wards with a possibility of involvement in newborn resuscitation.

Exclusion criteria

* Health workers providing care in other wards other than maternity and pediatrics.

Design outcomes

Primary

MeasureTime frameDescription
Helping Babies Breathe Objective Structured Clinical Exam (OSCE) B score12 months from initial HBB trainingstandardized comprehensive evaluation of HBB skills, 17 out of 23 constitutes a pass score with 23 being the highest score. The OSCE B is a standard Helping Babies Breathe assessment tool that comprises the steps required in successfully assisting a neonate in its transition after birth

Secondary

MeasureTime frameDescription
Bag and mask ventilation skills checkat unannounced visits within 12 months of trainingevaluation of bagging skills to assist breathing - score out of 14
App analytics - pattern of usageduring 12 months after initial training in intervention arm onlyautomated reports from the app regarding usage of different components of the app
App analytics - frequency of usageduring 12 months after initial training in intervention arm onlyfrequency of access to different parts of the app, duration of app usage
App analytics - trends of performanceduring 12 months after initial training in intervention arm onlytime trends of knowledge checks and simulation evaluations as noted in the app
Frequency of practiceduring 12 months after initial trainingfor both intervention and control arms, log-books will be reviewed for frequency of practice and in the intervention arm, this will be compared to what is reported through the app
Exit focus group feedback on barriers and facilitators to HBB training and skills maintenanceat end of study (12 months from the start)both intervention and control group participants will be interviewed to provide feedback on facilitators and barriers to HBB skills maintenance, and in the intervention arm, whether HBB Prompt helped or hindered their skills maintenance
OSCE B scoreimmediately before initial HBB trainingstandardized comprehensive evaluation of HBB skills, 17 out of 23 constitutes a pass score
HBB 2.0 Knowledge Checkat unannounced visits within 12 months of training18 questions pertaining to newborn resuscitation
Bag and mask ventilation quality measures with AIR Deviceat unannounced visits within 12 months of trainingAugmented Infant Resuscitator (AIR) to objectively measure quality of newborn resuscitation during every ventilation epoch. AIR records time stamped data on ventilation quality, such as presence of air leak or obstruction and ventilation rate (www.air-device.com)
OSCE Aat unannounced visits within 12 months of trainingstandardized evaluation of resuscitation skills (slightly different scenario than for OSCE B), 9 out of 12 constitutes a pass score

Other

MeasureTime frameDescription
Fresh stillbirthsduring 12 month study periodnumber of fresh stillbirths will be recorded from the birth register of each site
In hospital neonatal mortalityduring 12 month study periodnumber of neonatal deaths prior to discharge will be recorded from the birth register of each site
Infants requiring baggingduring 12 month study periodnumber of babies requiring bagging will be recorded from the birth register of each site
Delivery Volumeduring 12 month study periodnumber of births will be recorded from the birth register of each site

Countries

Uganda

Contacts

Primary ContactFrancis Bajunirwe, PhD
fbaj@must.ac.ug+256772576396

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026