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Development of a Mobile Application for HBB Prompt Study (HBB-Prompt)

Primary Purpose

Birth Asphyxia, Neonatal Death

Status
Unknown status
Phase
Not Applicable
Locations
Uganda
Study Type
Interventional
Intervention
HBB Prompt
Low-Dose High Frequency training
Sponsored by
Mbarara University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Birth Asphyxia focused on measuring Helping Babies Breathe, newborn resuscitation, skills retention, mobile health, user-centred design

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Mbarara University of Science and TechnologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

HBB Prompt

Control

Arm Description

The investigators will train frontline health providers in Helping Babies Breathe (HBB) 2.0 and Essential Care for Every Baby (ECEB). Providers will undergo ECEB training in addition to HBB as these training programs are recommended by the Uganda Ministry of Health to be offered together. Providers at this hospital will have access to the most updated version of HBB Prompt (beta) after HBB training. Participants in will be asked to achieve a minimum practice target of once per day (low-dose high frequency training). The recommended frequency to use the app will be once per shift.

The investigators will train frontline health providers in Helping Babies Breathe (HBB) 2.0 and Essential Care for Every Baby (ECEB). Providers will undergo ECEB training in addition to HBB as these training programs are recommended by the Uganda Ministry of Health to be offered together. The control group will not have exposure to the HBB Prompt app post training. Participants in will be asked to achieve a minimum practice target of once per day (low-dose high frequency training).

Outcomes

Primary Outcome Measures

Helping Babies Breathe Objective Structured Clinical Exam (OSCE) B score
standardized 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 Outcome Measures

OSCE B score
standardized comprehensive evaluation of HBB skills, 17 out of 23 constitutes a pass score
OSCE B score
standardized comprehensive evaluation of HBB skills, 17 out of 23 constitutes a pass score
OSCE B score
standardized comprehensive evaluation of HBB skills, 17 out of 23 constitutes a pass score
OSCE B score
standardized comprehensive evaluation of HBB skills, 17 out of 23 constitutes a pass score
HBB 2.0 Knowledge Check
18 questions pertaining to newborn resuscitation
Bag and mask ventilation skills check
evaluation of bagging skills to assist breathing - score out of 14
Bag and mask ventilation quality measures with AIR Device
Augmented 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 A
standardized evaluation of resuscitation skills (slightly different scenario than for OSCE B), 9 out of 12 constitutes a pass score
App analytics - pattern of usage
automated reports from the app regarding usage of different components of the app
App analytics - frequency of usage
frequency of access to different parts of the app, duration of app usage
App analytics - trends of performance
time trends of knowledge checks and simulation evaluations as noted in the app
Frequency of practice
for 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 maintenance
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

Full Information

First Posted
May 15, 2018
Last Updated
July 4, 2018
Sponsor
Mbarara University of Science and Technology
Collaborators
The Hospital for Sick Children
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1. Study Identification

Unique Protocol Identification Number
NCT03577054
Brief Title
Development of a Mobile Application for HBB Prompt Study
Acronym
HBB-Prompt
Official Title
Development of a Mobile Application Through User Centered Design to Improve Helping Babies Breath Skills Retention
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 14, 2018 (Actual)
Primary Completion Date
April 30, 2019 (Anticipated)
Study Completion Date
June 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mbarara University of Science and Technology
Collaborators
The Hospital for Sick Children

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Birth Asphyxia, Neonatal Death
Keywords
Helping Babies Breathe, newborn resuscitation, skills retention, mobile health, user-centred design

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Outcomes assessor at analysis stage will be masked to allocation of participants
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HBB Prompt
Arm Type
Experimental
Arm Description
The investigators will train frontline health providers in Helping Babies Breathe (HBB) 2.0 and Essential Care for Every Baby (ECEB). Providers will undergo ECEB training in addition to HBB as these training programs are recommended by the Uganda Ministry of Health to be offered together. Providers at this hospital will have access to the most updated version of HBB Prompt (beta) after HBB training. Participants in will be asked to achieve a minimum practice target of once per day (low-dose high frequency training). The recommended frequency to use the app will be once per shift.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
The investigators will train frontline health providers in Helping Babies Breathe (HBB) 2.0 and Essential Care for Every Baby (ECEB). Providers will undergo ECEB training in addition to HBB as these training programs are recommended by the Uganda Ministry of Health to be offered together. The control group will not have exposure to the HBB Prompt app post training. Participants in will be asked to achieve a minimum practice target of once per day (low-dose high frequency training).
Intervention Type
Behavioral
Intervention Name(s)
HBB Prompt
Other Intervention Name(s)
mobile app
Intervention Description
Mobile app developed through user-centred design in phase 1 of this study
Intervention Type
Behavioral
Intervention Name(s)
Low-Dose High Frequency training
Other Intervention Name(s)
LDHF
Intervention Description
Participants will be encouraged to practice their HBB skills daily
Primary Outcome Measure Information:
Title
Helping Babies Breathe Objective Structured Clinical Exam (OSCE) B score
Description
standardized 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
Time Frame
12 months from initial HBB training
Secondary Outcome Measure Information:
Title
OSCE B score
Description
standardized comprehensive evaluation of HBB skills, 17 out of 23 constitutes a pass score
Time Frame
immediately before initial HBB training
Title
OSCE B score
Description
standardized comprehensive evaluation of HBB skills, 17 out of 23 constitutes a pass score
Time Frame
immediately after initial HBB training
Title
OSCE B score
Description
standardized comprehensive evaluation of HBB skills, 17 out of 23 constitutes a pass score
Time Frame
3 months from initial HBB training
Title
OSCE B score
Description
standardized comprehensive evaluation of HBB skills, 17 out of 23 constitutes a pass score
Time Frame
6 months from initial HBB training
Title
HBB 2.0 Knowledge Check
Description
18 questions pertaining to newborn resuscitation
Time Frame
at unannounced visits within 12 months of training
Title
Bag and mask ventilation skills check
Description
evaluation of bagging skills to assist breathing - score out of 14
Time Frame
at unannounced visits within 12 months of training
Title
Bag and mask ventilation quality measures with AIR Device
Description
Augmented 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)
Time Frame
at unannounced visits within 12 months of training
Title
OSCE A
Description
standardized evaluation of resuscitation skills (slightly different scenario than for OSCE B), 9 out of 12 constitutes a pass score
Time Frame
at unannounced visits within 12 months of training
Title
App analytics - pattern of usage
Description
automated reports from the app regarding usage of different components of the app
Time Frame
during 12 months after initial training in intervention arm only
Title
App analytics - frequency of usage
Description
frequency of access to different parts of the app, duration of app usage
Time Frame
during 12 months after initial training in intervention arm only
Title
App analytics - trends of performance
Description
time trends of knowledge checks and simulation evaluations as noted in the app
Time Frame
during 12 months after initial training in intervention arm only
Title
Frequency of practice
Description
for 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
Time Frame
during 12 months after initial training
Title
Exit focus group feedback on barriers and facilitators to HBB training and skills maintenance
Description
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
Time Frame
at end of study (12 months from the start)
Other Pre-specified Outcome Measures:
Title
Delivery Volume
Description
number of births will be recorded from the birth register of each site
Time Frame
during 12 month study period
Title
Infants requiring bagging
Description
number of babies requiring bagging will be recorded from the birth register of each site
Time Frame
during 12 month study period
Title
Fresh stillbirths
Description
number of fresh stillbirths will be recorded from the birth register of each site
Time Frame
during 12 month study period
Title
In hospital neonatal mortality
Description
number of neonatal deaths prior to discharge will be recorded from the birth register of each site
Time Frame
during 12 month study period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Francis Bajunirwe, PhD
Phone
+256772576396
Email
fbaj@must.ac.ug
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Santorino Data, MBChB, MMed
Organizational Affiliation
Mbarara University of Science and Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mbarara University of Science and Technology
City
Mbarara
Country
Uganda
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Santorino Data, MBChB, MMed
Phone
256712214458
Email
sdata@must.ac.ug
First Name & Middle Initial & Last Name & Degree
Santorino Data, MBChB, MMed

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
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Citation
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Citation
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Results Reference
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Development of a Mobile Application for HBB Prompt Study

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