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.: PACTR202203880375077 Date of Approval: 28/03/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Testing the effect of digital secondary school resources for informed health choices among secondary school students in Rwanda.
Official scientific title Effects of Informed Health Choices secondary school resources on the ability of Rwandan students to think critically about health: protocol for a cluster-randomised trial
Brief summary describing the background and objectives of the trial Young people are exposed to many claims about the effects of actions to protect or improve health. To make good health choices, they need the ability to critically assess the reliability of those claims. Critical thinking is a core competence in the Rwandan secondary school curriculum and in many other countries. However, critical thinking about health is rarely taught in Rwanda. Digital secondary school resources for critical thinking about health can potentially help young people to think critically about health and be widely disseminated at low cost. If their use is shown to be effective, they can improve young people’s critical thinking about health as they become adults and take increasing responsibility for their health choices. The objective of this research is to evaluate the effects of using digital secondary school resources to help students learn to think critically about health claims, research used to support those claims, and choices about what to do.
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
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 18/04/2022
Actual trial start date
Anticipated date of last follow up 31/07/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 3276
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
Parallel: different groups receive different interventions at same time during study 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 secondary school resources The Be smart about your health secondary school resources include 10 lessons to be delivered to students in a classroom setting for one term. Each lesson will be delivered during a single 40-minute period. The teacher will deliver the intervention during a single school term, usually 12 weeks, covering 10 lessons. Schools allocated to the intervention will use the the Be smart about your health secondary school resources for teaching critical thinking about health. We have developed the resources iteratively using a Human-Centred Design Approach. We have worked closely with students, teachers, and curriculum developers in Rwanda, Uganda, and Kenya to develop the resources. The resources cover nine key concepts that people need to understand and apply to critically think about health choices. The learning resources include 10 lessons to be delivered to students in a classroom setting during a single school term. Each lesson is designed to be delivered during a single 40-minute period. The intervention delivery will be flexible where teachers will be allowed to modify the lesson delivery to fit their context. We will include all participants in the analysis regardless of what and how the lessons were delivered. In addition to IHC lessons, teachers will continue to teach other subjects as usual and there will be no restriction on what is taught or how it is delivered. We will contact participating schools in the intervention arm before the start of the school term and invite all participating teachers to attend a 2-3-day workshop. The workshop will be at least one to two weeks before the start of the school term. In the meeting we will describe to the teachers why critical thinking about health is important, the trial process, expectations from schools and teachers and an overview of 10 lessons in the learning resources. In addition, we will explain the process of data collection at the end of the term. 1638
Control Group Standard teaching of competence based curriculum with no additional resources N/A The term will be 12 weeks Schools in the control arm will continue with the usual class instruction using a curriculum “competence-based curriculum”. The curriculum was implemented since 2016 with an aim to develop students’ core competences including critical thinking among others. In addition, the curriculum includes health subjects where critical thinking is expected to be developed. There will be no other resources given to schools in the control arm. 1638 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Schools • Public, private and government aided schools • Schools with electricity • Schools using national competence-based curriculum • Schools with lower secondary school section • Schools with computers • Schools with projectors and Internet connection • Schools with over 100 students • Schools with over 10 teachers • School directors consenting for the school to participate Students • Senior two students Teachers • Teachers teaching one of the following subjects: Biology and Health sciences, Physics, Chemistry and Mathematics • Teachers who have smartphone/computer • Teachers consenting to participate in the study Schools • School that participated in the user testing and pilot of digital resources • International schools • Schools that provide special needs education • Schools that are difficult to reach i.e those with an estimated travel time of more than four hours from Kigali Students • Students who choose not to participate Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Child: 6 Year-12 Year 10 Year(s) 24 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 12/02/2022 Rwanda National Ethics Committee
Ethics Committee Address
Street address City Postal code Country
KN 3 Rd, Kigali Kigali 250 Rwanda
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome measure is the difference between the intervention and control schools in the proportion of children with a passing score. At the end of the term and after one year
Secondary Outcome The mean difference in the score (percent of correct answers) for the 18 questions that assess the students’ ability to apply the nine concepts covered by the be smart about your health secondary school resources At the end of term and after one year
Secondary Outcome The difference in the proportion of students with a score indicating mastery of the concepts covered by the be smart about your health secondary school resources At the end of the term and after one year
Secondary Outcome The difference in the proportion of students that answered both questions correctly for each of the nine concepts covered by the be smart about your health secondary school resources At the end of the term and after one year
Secondary Outcome The difference in intended behaviours and self-efficacy At the end of the term and after one year
Secondary Outcome The difference in scores on standardised national examinations. At the end of the term and after one year
Secondary Outcome The difference in the proportion of teachers with a passing score and a mastery score, and the mean difference in the score for teachers At the end of the term and after one year
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University of Rwanda School of Public Health KK 19 Av Kigali 00250 Rwanda
FUNDING SOURCES
Name of source Street address City Postal code Country
Research Council of Norway Drammensveien 288 Oslo 1327 Lysa Norway
University of Rwanda Center of Excellence for Biomedical Engineering and Ehealth KK 19 Av Kigali 250 Rwanda
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Andrew David Oxman Linhusveien 15, 0755 Oslo Norway Individual
Secondary Sponsor Laetitia Nyirazinyoye KK 19 Av Kigali 250 Rwanda Individual
COLLABORATORS
Name Street address City Postal code Country
Norwegian Institute of Public Health N-0213 Oslo Norway
Makerere University Mulago Hil Kampala 7072 Uganda
Tropical Institute of Community Health and Development Wathorego Kisumu Kenya
Epistemonikos foundation Av. Holanda 895 Santiago Chile
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Michael Mugisha michaelmgsh@gmail.com +250788596947 KK 19 av
City Postal code Country Position/Affiliation
Kigali Rwanda PhD fellow at the University of Oslo and staff of University of Rwanda
Role Name Email Phone Street address
Public Enquiries Laetitia Nyirazinyoye ntirenganyal1@gmail.com +250788683209 KK 19 av
City Postal code Country Position/Affiliation
Kigali Rwanda Professor of Public Health
Role Name Email Phone Street address
Scientific Enquiries Andrew Oxman oxman@online.no +4748254924 Linhusveien 15
City Postal code Country Position/Affiliation
Oslo Norway Research Director
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data will be shared upon request. Study Protocol After analysis (after two years from now) Data will be accessed by anyone who may request them through writing an email to PI.
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