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.: PACTR202204861458660 Date of Approval: 14/04/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Does the use of the Informed Health Choices teaching resources improve the secondary students’ ability to critically think about health in Uganda? A cluster randomized trial protocol
Official scientific title Does the use of the Informed Health Choices teaching resources improve the secondary students’ ability to critically think about health in Uganda? A cluster randomized trial protocol
Brief summary describing the background and objectives of the trial Background To make well-informed choices, people must possess skills to assess the trust-worthiness of health-related claims. It is important that young people learn to assess the reliability of claims to inform decisions, both when making their own choices and as citizens participating in a democracy. This trial aims to evaluate the effect of Informed Health Choices (IHC) teaching resources on secondary school students’ ability to assess health-related claims and make informed choices. Methods This will be a two-arm cluster-randomised trial. We will randomise 80 lower secondary schools to use the IHC secondary school digital teaching resources. The resources for teachers include 10 lessons to be delivered in a single school term, using lesson plans developed for classrooms equipped with only a black-board or with a projector. Teachers in the intervention arm will be invited to a three-day teacher training workshop. Teachers in the control schools will con-tinue teaching the national curriculum. Uganda’s National Curriculum Devel-opment Centre introduced a new competence-based curriculum in 2020. This curriculum has critical thinking as one of seven generic skills.to be taught across all subjects. The curriculum does not explicitly include critical thinking about health. The IHC lessons address nine prioritised key concepts. We will use multiple choice questions – two for each key concept - to evaluate the stu-dent’s ability to assess claims and make informed choices. We will measure out-comes at the end of the school term, and again after one-year to assess reten-tion of what was learned. Expected results Based on previous work done in Ugandan primary schools, we anticipate that the use of the teaching resources will lead to a large improvement in the lower secondary school students’ ability to assess claims and make informed health choices.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Critical thinking about health. All the treatments for all conditions/illnesses we experience
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 16/05/2022
Actual trial start date
Anticipated date of last follow up 31/08/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 6080
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Be smart about your health Ten lessons with each lesson taking a single period (40 minutes) once a week. 13 Weeks. The 10 lessons will be taught in a single school term in the Uganda national lower secondary schools. The IHC secondary school resources (Be smart about your health) are open access digital learning resources for lower-secondary school teachers. They include 10 lessons in two formats: lesson plans for teachers using a blackboard and for teachers using a projector. The aim is for students to learn to think critically about health claims and choices. The resources will be made available to schools in the intervention group. Teachers in those schools will download the resources and deliver the lessons. Each lesson plan includes a quiz to review and reinforce what was learned in the previous lesson, an activity, and a wrap-up to reinforce the learning goals for the lesson. For each of the 10 lessons there are learning goals, a summary of the lesson, key terms introduced in the lesson, the main teaching strategies used in the lesson, explanations of the Key Concepts (including examples and common misunderstandings), and suggestions for preparation before the les-son. In addition, there is an introduction, a glossary, a collection of examples that can be used to illustrate the Key Concepts, and information about the teaching strategies that are used (based on an overview of systematic re-views).[38] 3040
Control Group Teaching the national standard curriculum Continue with school planned lessons that can range between 10-13 lessons a week 13 Weeks. A single school term in the Uganda national lower secondary schools. The national standard lower secondary school curriculum in Uganda, which does not include teaching critical thinking about health. 3040 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
We will include secondary schools that have a lower (ordinary) level section that teaches the national curriculum. Only schools for which the head teacher and teachers provide written consent to participate and own a smart phone will be included in the trial. We will exclude special needs schools for students with auditory and visual impairments, schools that participated in user-testing and piloting of the IHC learning resources, and adult only education schools (Schools where individual usually over the age of 18 years go for secondary education). Adolescent: 13 Year-18 Year 13 Year(s) 17 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 23/09/2020 Makerere University School of Medicine Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
P. o. Box 7072 Kampala Kampala 7072 Uganda
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome measure is the proportion of children with a passing score on the Critical Thinking about Health Test. At both the End of the school term and after one year
Secondary Outcome • mean score (percentage of correct answers) on the evaluation tool used to measure the students’ ability to apply the key concepts addressed by the intervention • proportion of students with a score indicating mastery of the concepts • proportion of students who answer both questions correctly for each of the nine concepts • students’ intended behaviours and self-efficacy measured using questions added on the Critical Thinking about Health Test. • self-reported behaviours • overall academic performance in O-level compulsory subjects: biology, chemistry, physics, mathematics, english, history & political education, and geography. This will be collected for the term prior to the when the intervention is delivered, at the end of the term after the intervention de-livery and at one year after the intervention delivery. • proportion of teachers with a passing score, their mean score, and the proportion with a score indicating mastery of the concepts using the same evaluation tool used to measure the students’ ability to apply the key concepts addressed by the intervention At both the End of the school term and after one year
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Makerere University College of Health Sciences P.O. Box 7072, Mulago Hill Kampala Uganda
FUNDING SOURCES
Name of source Street address City Postal code Country
Research Council of Norway Drammensveien 288 Oslo 0283 Norway
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Norwegian Institute of Public Health 222 Skoyen OSLO 0213 Norway University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Public Enquiries Nelson Sewankambo sewankam@infocom.co.ug +256782366751 7072
City Postal code Country Position/Affiliation
Kampala Uganda Supervisor Professor of Medicine
Role Name Email Phone Street address
Principal Investigator Ronald Ssenyonga rssenyonga12@gmail.com +256700733108 7072
City Postal code Country Position/Affiliation
Kampala Uganda PhD fellow University of Oslo
Role Name Email Phone Street address
Scientific Enquiries Andrew Oxman oxman@online.no +4748254924 Oslo
City Postal code Country Position/Affiliation
Oslo Norway Supervisor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes We will provide access to individual participants deidentified data upon request Informed Consent Form,Study Protocol Two years from now The deidentified data will be made public upon request to the principal investigator
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information