Clinical trial NCT03577054: Development of a Mobile Application for HBB Prompt Study
Official title: Development of a Mobile Application Through User Centered Design to Improve Helping Babies Breath Skills Retention
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Birth Asphyxia
Neonatal Death
Keywords: Helping Babies Breathe
newborn resuscitation
skills retention
mobile health
user-centred design
Lead sponsor: Mbarara University of Science and Technology
Sponsor class: OTHER
Collaborators: name: The Hospital for Sick Children
First posted: 2018-07-05
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Helping Babies Breathe Objective Structured Clinical Exam (OSCE) B score
timeFrame: 12 months from initial HBB training
Secondary outcomes:
measure: OSCE B score
timeFrame: immediately before initial HBB training
measure: OSCE B score
timeFrame: immediately after initial HBB training
measure: OSCE B score
timeFrame: 3 months from initial HBB training
measure: OSCE B score
timeFrame: 6 months from initial HBB training
measure: HBB 2.0 Knowledge Check
timeFrame: at unannounced visits within 12 months of training
measure: Bag and mask ventilation skills check
timeFrame: at unannounced visits within 12 months of training
measure: Bag and mask ventilation quality measures with AIR Device
timeFrame: at unannounced visits within 12 months of training
measure: OSCE A
timeFrame: at unannounced visits within 12 months of training
measure: App analytics - pattern of usage
timeFrame: during 12 months after initial training in intervention arm only
measure: App analytics - frequency of usage
timeFrame: during 12 months after initial training in intervention arm only
measure: App analytics - trends of performance
timeFrame: during 12 months after initial training in intervention arm only
measure: Frequency of practice
timeFrame: during 12 months after initial training
measure: Exit focus group feedback on barriers and facilitators to HBB training and skills maintenance
timeFrame: at end of study (12 months from the start)
Other outcomes:
measure: Delivery Volume
timeFrame: during 12 month study period
measure: Infants requiring bagging
timeFrame: during 12 month study period
measure: Fresh stillbirths
timeFrame: during 12 month study period
measure: In hospital neonatal mortality
timeFrame: during 12 month study period
Locations:
city: Mbarara
country: Uganda
facility: Mbarara University of Science and Technology
Study officials:
affiliation: Mbarara University of Science and Technology
name: Santorino Data, MBChB, MMed
role: PRINCIPAL_INVESTIGATOR
References:
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