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

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.
 
ClinicalTrials.gov Identifier: NCT03577054
Recruitment Status : Unknown
Verified July 2018 by Mbarara University of Science and Technology.
Recruitment status was:  Recruiting
First Posted : July 5, 2018
Last Update Posted : July 6, 2018
Sponsor:
Collaborator:
The Hospital for Sick Children
Information provided by (Responsible Party):
Mbarara University of Science and Technology

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.

Condition or disease Intervention/treatment Phase
Birth Asphyxia Neonatal Death Behavioral: HBB Prompt Behavioral: Low-Dose High Frequency training Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Outcomes assessor at analysis stage will be masked to allocation of participants
Primary Purpose: Other
Official Title: Development of a Mobile Application Through User Centered Design to Improve Helping Babies Breath Skills Retention
Actual Study Start Date : May 14, 2018
Estimated Primary Completion Date : April 30, 2019
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: HBB Prompt

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.

Behavioral: HBB Prompt
Mobile app developed through user-centred design in phase 1 of this study
Other Name: mobile app

Behavioral: Low-Dose High Frequency training
Participants will be encouraged to practice their HBB skills daily
Other Name: LDHF

Placebo Comparator: Control

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).

Behavioral: Low-Dose High Frequency training
Participants will be encouraged to practice their HBB skills daily
Other Name: LDHF




Primary Outcome Measures :
  1. Helping Babies Breathe Objective Structured Clinical Exam (OSCE) B score [ Time Frame: 12 months from initial HBB training ]
    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 :
  1. OSCE B score [ Time Frame: immediately before initial HBB training ]
    standardized comprehensive evaluation of HBB skills, 17 out of 23 constitutes a pass score

  2. OSCE B score [ Time Frame: immediately after initial HBB training ]
    standardized comprehensive evaluation of HBB skills, 17 out of 23 constitutes a pass score

  3. OSCE B score [ Time Frame: 3 months from initial HBB training ]
    standardized comprehensive evaluation of HBB skills, 17 out of 23 constitutes a pass score

  4. OSCE B score [ Time Frame: 6 months from initial HBB training ]
    standardized comprehensive evaluation of HBB skills, 17 out of 23 constitutes a pass score

  5. HBB 2.0 Knowledge Check [ Time Frame: at unannounced visits within 12 months of training ]
    18 questions pertaining to newborn resuscitation

  6. Bag and mask ventilation skills check [ Time Frame: at unannounced visits within 12 months of training ]
    evaluation of bagging skills to assist breathing - score out of 14

  7. Bag and mask ventilation quality measures with AIR Device [ Time Frame: at unannounced visits within 12 months of training ]
    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)

  8. OSCE A [ Time Frame: at unannounced visits within 12 months of training ]
    standardized evaluation of resuscitation skills (slightly different scenario than for OSCE B), 9 out of 12 constitutes a pass score

  9. App analytics - pattern of usage [ Time Frame: during 12 months after initial training in intervention arm only ]
    automated reports from the app regarding usage of different components of the app

  10. App analytics - frequency of usage [ Time Frame: during 12 months after initial training in intervention arm only ]
    frequency of access to different parts of the app, duration of app usage

  11. App analytics - trends of performance [ Time Frame: during 12 months after initial training in intervention arm only ]
    time trends of knowledge checks and simulation evaluations as noted in the app

  12. Frequency of practice [ Time Frame: during 12 months after initial training ]
    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

  13. Exit focus group feedback on barriers and facilitators to HBB training and skills maintenance [ Time Frame: at 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


Other Outcome Measures:
  1. Delivery Volume [ Time Frame: during 12 month study period ]
    number of births will be recorded from the birth register of each site

  2. Infants requiring bagging [ Time Frame: during 12 month study period ]
    number of babies requiring bagging will be recorded from the birth register of each site

  3. Fresh stillbirths [ Time Frame: during 12 month study period ]
    number of fresh stillbirths will be recorded from the birth register of each site

  4. In hospital neonatal mortality [ Time Frame: during 12 month study period ]
    number of neonatal deaths prior to discharge will be recorded from the birth register of each site



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

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): NCT03577054


Contacts
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Contact: Francis Bajunirwe, PhD +256772576396 fbaj@must.ac.ug

Locations
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Uganda
Mbarara University of Science and Technology Recruiting
Mbarara, Uganda
Contact: Santorino Data, MBChB, MMed    256712214458    sdata@must.ac.ug   
Principal Investigator: Santorino Data, MBChB, MMed         
Sponsors and Collaborators
Mbarara University of Science and Technology
The Hospital for Sick Children
Investigators
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Principal Investigator: Santorino Data, MBChB, MMed Mbarara University of Science and Technology
  Study Documents (Full-Text)

Documents provided by Mbarara University of Science and Technology:
Study Protocol  [PDF] February 18, 2018

Publications:
FDIs, I. (2009). 9241-210 (2009). Ergonomics of human system interaction-Part 210: Human-centered design for interactive systems (formerly known as 13407). International Organization for Standardization (ISO). Switzerland.
Krueger RA, Casey MA. Focus Groups: A practical guide for applied research. 4th ed. California: Sage Publications Inc., 2008.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Mbarara University of Science and Technology
ClinicalTrials.gov Identifier: NCT03577054    
Other Study ID Numbers: MUST 16/09-17
First Posted: July 5, 2018    Key Record Dates
Last Update Posted: July 6, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mbarara University of Science and Technology:
Helping Babies Breathe
newborn resuscitation
skills retention
mobile health
user-centred design
Additional relevant MeSH terms:
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Perinatal Death
Asphyxia Neonatorum
Asphyxia
Death
Pathologic Processes
Wounds and Injuries
Pregnancy Complications
Infant, Newborn, Diseases