Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201901783811130 Date of Registration: 15/01/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Protocol for a Randomised Experiment of Smartphone-Based Training for Paediatric Emergency Care in Low-resource Settings.
Official scientific title Protocol for a Randomised Experiment of Smartphone-based Adaptive Instructional Feedback Support on Healthcare Workers' Learning Gains for Paedictric Emergency Care in Low-resource Settings
Brief summary describing the background and objectives of the trial While smartphone-based clinical training to support emergency care training is more affordable than traditional avenues of training, it is still in its infancy, remains poorly implemented, and current implementations tend to be invariant to the evolving learning needs of the intended users. This randomised experiment aims to assess the effectiveness of offering adaptive feedback versus standard feedback on learning gains for smartphone-based training platforms.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Neonatal Diseases,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 01/02/2019
Actual trial start date 01/02/2019
Anticipated date of last follow up 31/07/2019
Actual Last follow-up date 31/07/2019
Anticipated target sample size (number of participants) 180
Actual target sample size (number of participants) 247
Recruitment status Completed
Publication URL https://www.jmir.org/2020/7/e17100/
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Central randomisation by phone/fax Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Adaptive feedback After every failed attempt on the knowledge component (quiz) For the first two complete clinical training sessions completed through the LIFE smartphone application The learner will receive feedback notification after an incorrect attempt with the level of explanation and hint provided-based on the probability that they get the next try correct given their performance on the previous quizzes in the current learning session. 90
Control Group Standardised feedback After every failed attempt on the knowledge component (quiz) For the first two complete clinical training sessions completed through the LIFE smartphone application Standardised notification without any explanation after the first incorrect attempt, with standardised detailed description and explanation of correct responses for every incorrect attempt after the second incorrect attempt onwards. 90 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Health care workers who are in nursing, clinical or medical professional cadres that offer bedside patient care Health care workers in practice and those in training are eligible for inclusion into the experiment. Health care workers who have retired from clinical practice and participants who are not healthcare workers will be excluded from the study. 80 and over: 80+ Year,Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 80 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 12/02/2018 Central University Research and Ethics Committee of Oxford University
Ethics Committee Address
Street address City Postal code Country
15 Norham Gardens Oxford, OX2 6PY 01865 United Kingdom
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 22/05/2018 KEMRI Scientific and Ethical Review Committee
Ethics Committee Address
Street address City Postal code Country
House 8, KEMRI Headquarters, Off Mbagathi Way Nairobi 00200 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Learning gain assessed as the difference in performance between two initial round of complete learning sessions through theLIFE smartphone application. Assessed after the performance from the second round of completing training through the mobile application has been recorded.
Secondary Outcome Time difference between the use of the intervention Assessed for each subsequent learning encounter after the first round of play as the time difference in days between each learning encounter.
Secondary Outcome The number of opportunities per knowledge component Assessed as the number of times the learner has encountered a particular knowledge component before attempting it.
Secondary Outcome Time on task Assessed as the time spent on each learning component when attempting to address it.
Secondary Outcome Level of feedback provided Assessed as the level of hint detail provided for each knowledge component attempted
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
KEMRI Wellcome Trust Research Programme 197 Lenana Place, Lenana Road Nairobi 00100 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
Economic and Social Research Council UK Polaris House North Star Avenue Swindon United Kingdom
Global Challenges Research Fund Polaris House, North Star Avenue, Swindon SN2 1FL United Kingdom
USAID Ronald Reagan Building, 20523-1000 Washington DC United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor KEMRI Wellcome Trust Research Programme 197 Lenana Place, Lenana Road Nairobi 00100 Kenya Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
Niall Winters 15 Norham Gardens Oxford United Kingdom
Chris Paton The Peter Medawar Building for Pathogen Research, South Parks Road, Oxford United Kingdom
Mike English KEMRI-Wellcome Trust Research Programme, 197 Lenana Place, Lenana Road Nairobi Kenya
Conrad Wanyama KEMRI-Wellcome Trust Research Programme, 197 Lenana Place, Lenana Road Nairobi Kenya
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Timothy Tuti timothy.tuti@kellogg.ox.ac.uk +447501966958 60 Banbury Road
City Postal code Country Position/Affiliation
Oxford OX2 6PY United Kingdom DPhil Fellow
Role Name Email Phone Street address
Scientific Enquiries Timothy Tuti timothy.tuti@kellogg.ox.ac.uk +447501966958 60 Banbury Road
City Postal code Country Position/Affiliation
Oxford OX2 6PY United Kingdom DPhil Fellow
Role Name Email Phone Street address
Public Enquiries Timothy Tuti timothy.tuti@kellogg.ox.ac.uk +447501966958 60 Banbury Road
City Postal code Country Position/Affiliation
Oxford OX2 6PY United Kingdom DPhil Fellow
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Anonymised student-step data for each attempt at each knowledge component (quiz) in each learning session, including time spent on learning task, count of previous attempts on learning task, level of feedback provided, and the number of times before the learner successfully attempted the quiz. Informed Consent Form,Study Protocol From January 2020 onwards Controlled access, provided after successful application to KEMRI's Scientific and Ethics Review Unit for any researchers who meet KEMRI's criteria for access to confidential data
URL Results Available Results Summary Result Posting Date First Journal Publication Date
https://www.jmir.org/2020/7/e17100/ Yes 22/10/2021 06/07/2020
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 22/10/2021 Result - 22/10/2021
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks https://www.researchprotocols.org/2019/7/e13034/
Changes to trial information