Development of a Mobile Application for HBB Prompt Study

NCT ID: NCT03577054

Last Updated: 2018-07-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-14

Study Completion Date

2019-06-30

Brief Summary

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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

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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.

Conditions

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Birth Asphyxia Neonatal Death

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel Assignment
Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

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

Study Groups

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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.

Group Type EXPERIMENTAL

HBB Prompt

Intervention Type BEHAVIORAL

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

Low-Dose High Frequency training

Intervention Type BEHAVIORAL

Participants will be encouraged to practice their HBB skills daily

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).

Group Type PLACEBO_COMPARATOR

Low-Dose High Frequency training

Intervention Type BEHAVIORAL

Participants will be encouraged to practice their HBB skills daily

Interventions

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HBB Prompt

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

Intervention Type BEHAVIORAL

Low-Dose High Frequency training

Participants will be encouraged to practice their HBB skills daily

Intervention Type BEHAVIORAL

Other Intervention Names

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mobile app LDHF

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Hospital for Sick Children

OTHER

Sponsor Role collaborator

Mbarara University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Santorino Data, MBChB, MMed

Role: PRINCIPAL_INVESTIGATOR

Mbarara University of Science and Technology

Locations

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Mbarara University of Science and Technology

Mbarara, , Uganda

Site Status RECRUITING

Countries

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Uganda

Central Contacts

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Francis Bajunirwe, PhD

Role: CONTACT

+256772576396

Facility Contacts

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Santorino Data, MBChB, MMed

Role: primary

256712214458

References

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Msemo G, Massawe A, Mmbando D, Rusibamayila N, Manji K, Kidanto HL, Mwizamuholya D, Ringia P, Ersdal HL, Perlman J. Newborn mortality and fresh stillbirth rates in Tanzania after helping babies breathe training. Pediatrics. 2013 Feb;131(2):e353-60. doi: 10.1542/peds.2012-1795. Epub 2013 Jan 21.

Reference Type BACKGROUND
PMID: 23339223 (View on PubMed)

Kc A, Wrammert J, Clark RB, Ewald U, Vitrakoti R, Chaudhary P, Pun A, Raaijmakers H, Malqvist M. Reducing Perinatal Mortality in Nepal Using Helping Babies Breathe. Pediatrics. 2016 Jun;137(6):e20150117. doi: 10.1542/peds.2015-0117.

Reference Type BACKGROUND
PMID: 27225317 (View on PubMed)

Goudar SS, Somannavar MS, Clark R, Lockyer JM, Revankar AP, Fidler HM, Sloan NL, Niermeyer S, Keenan WJ, Singhal N. Stillbirth and newborn mortality in India after helping babies breathe training. Pediatrics. 2013 Feb;131(2):e344-52. doi: 10.1542/peds.2012-2112. Epub 2013 Jan 21.

Reference Type BACKGROUND
PMID: 23339215 (View on PubMed)

Bang A, Patel A, Bellad R, Gisore P, Goudar SS, Esamai F, Liechty EA, Meleth S, Goco N, Niermeyer S, Keenan W, Kamath-Rayne BD, Little GA, Clarke SB, Flanagan VA, Bucher S, Jain M, Mujawar N, Jain V, Rukunga J, Mahantshetti N, Dhaded S, Bhandankar M, McClure EM, Carlo WA, Wright LL, Hibberd PL. Helping Babies Breathe (HBB) training: What happens to knowledge and skills over time? BMC Pregnancy Childbirth. 2016 Nov 22;16(1):364. doi: 10.1186/s12884-016-1141-3.

Reference Type BACKGROUND
PMID: 27875999 (View on PubMed)

Reisman J, Arlington L, Jensen L, Louis H, Suarez-Rebling D, Nelson BD. Newborn Resuscitation Training in Resource-Limited Settings: A Systematic Literature Review. Pediatrics. 2016 Aug;138(2):e20154490. doi: 10.1542/peds.2015-4490. Epub 2016 Jul 7.

Reference Type BACKGROUND
PMID: 27388500 (View on PubMed)

Mduma E, Ersdal H, Svensen E, Kidanto H, Auestad B, Perlman J. Frequent brief on-site simulation training and reduction in 24-h neonatal mortality--an educational intervention study. Resuscitation. 2015 Aug;93:1-7. doi: 10.1016/j.resuscitation.2015.04.019. Epub 2015 May 6.

Reference Type BACKGROUND
PMID: 25957942 (View on PubMed)

Arabi AM, Ibrahim SA, Ahmed SE, MacGinnea F, Hawkes G, Dempsey E, Ryan CA. Skills retention in Sudanese village midwives 1 year following Helping Babies Breathe training. Arch Dis Child. 2016 May;101(5):439-42. doi: 10.1136/archdischild-2015-309190. Epub 2016 Jan 29.

Reference Type BACKGROUND
PMID: 26826172 (View on PubMed)

Wyckoff MH, Aziz K, Escobedo MB, Kapadia VS, Kattwinkel J, Perlman JM, Simon WM, Weiner GM, Zaichkin JG. Part 13: Neonatal Resuscitation: 2015 American Heart Association Guidelines Update for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2015 Nov 3;132(18 Suppl 2):S543-60. doi: 10.1161/CIR.0000000000000267. No abstract available.

Reference Type BACKGROUND
PMID: 26473001 (View on PubMed)

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.

Reference Type BACKGROUND

Krueger RA, Casey MA. Focus Groups: A practical guide for applied research. 4th ed. California: Sage Publications Inc., 2008.

Reference Type BACKGROUND

Chan NH, Merali HS, Mistry N, Kealey R, Campbell DM, Morris SK, Data S. Development of a novel mobile application, HBB Prompt, with human factors and user-centred design for Helping Babies Breathe skills retention in Uganda. BMC Med Inform Decis Mak. 2021 Feb 4;21(1):39. doi: 10.1186/s12911-021-01406-z.

Reference Type DERIVED
PMID: 33541340 (View on PubMed)

Merali HS, Chan NH, Mistry N, Kealey R, Campbell D, Morris SK, Data S. Designing and evaluating a novel mobile application for Helping Babies Breathe skills retention in Uganda: comparative study protocol. BMJ Paediatr Open. 2019 Sep 3;3(1):e000561. doi: 10.1136/bmjpo-2019-000561. eCollection 2019.

Reference Type DERIVED
PMID: 31549001 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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MUST 16/09-17

Identifier Type: -

Identifier Source: org_study_id

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