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.: PACTR201606001679337 Date of Approval: 13/06/2016
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Evaluation of resources to teach children in low-income countries to assess claims about treatment effects: Protocol for a randomised trial
Official scientific title Evaluation of resources to teach children in low-income countries to assess claims about treatment effects: Protocol for a randomised trial
Brief summary describing the background and objectives of the trial Background: The ability to appraise claims about benefits and harms of treatments is crucial for informed healthcare decision making. This research aims to enable children in low-income countries to acquire and retain skills that will help them make informed healthcare choices by improving their ability to obtain, process and understand health information. Objective: To evaluate resources that teach children how to appraise claims about the benefits and harms of healthcare interventions (treatments). Study design: A two-arm cluster randomised trial with stratified random allocation. We will recruit 110 schools between February and April 2016. We will stratify participating schools by geographical setting (rural, semi-urban, or urban) and ownership (public or private). Setting: We will conduct the study in primary schools in the central region of Uganda. Intervention: The Informed Healthcare Choices (IHC) primary school resources consist of a textbook and a teachers¿ guide. The students in the intervention arm will get a textbook and attend nine lessons delivered by their teacher during a school term, with each lesson lasting 80 minutes. The lessons cover 12 key concepts that are relevant to assessing claims about treatments and making informed healthcare choices. The second arm will carry on with the current primary school curriculum. Primary outcome measures: We designed the CLAIM evaluation tool to measure people¿s ability to apply key concepts related to assessing claims about the effects of treatments and making informed healthcare choices. The CLAIM evaluation tool uses multiple choice questions addressing each of the 12 concepts covered by the IHC school resources. Using the CLAIM evaluation tool we will measure two primary outcomes: 1) the proportion of children that ¿pass¿, based on an absolute standard and 2) the average score. ¿
Type of trial RCT
Acronym (If the trial has an acronym then please provide) IHC Primary Schools
Disease(s) or condition(s) being studied Ability to assess claims about treatment effects
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 06/06/2016
Actual trial start date 15/06/2016
Anticipated date of last follow up 30/09/2016
Actual Last follow-up date 30/09/2016
Anticipated target sample size (number of participants) 120
Actual target sample size (number of participants) 110
Recruitment status Closed to recruitment,follow-up continuing
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 we will first draw a sample of districts from all the districts in the central region in Uganda. In the second stage we shall randomly sample schools proportionately from the selected districts, stratifying by school setting (urban, semi-urban and rural areas), and further by ownership (privately funded and government aided schools). Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group IHC primary school resources Nine double lessons for 9 weeks (one lesson per week) 9 weeks The intervention The IHC primary school resources include a children¿s textbook, a teachers¿ guide, a reminder chart and a children¿s exercise book. 55
Control Group Current Primary School Science Curriculum Nine double 9 weeks The control schools will continue with the current primary school science curriculum. 55 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Public and private primary schools in the central region of Uganda will be eligible to participate. We will exclude international schools, special needs children¿s schools for the deaf and blind, and schools that participated in the user testing and piloting of the resources. Children in primary level classes other than primary five will be excluded from participating in the study. Only schools which agree to participate and sign a consent form for participation will be included in the trial. 9 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 08/04/2016 School of Medicine, Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
P.O.Box 7072, New Mulago Hospital Complex, Clinical Trials' Building (Level 1) Kampala 00256 Uganda
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 22/08/2016 School of Medicine, Research Ethics Committe
Ethics Committee Address
Street address City Postal code Country
P.O.Box 7072, New Mulago Hospital Complex, Clinical Trials Building (Level 1) Kampala 00256 Uganda
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 1. The difference between the intervention and control groups in the proportion of children with a passing score. After 9 weeks. After one year.
Primary Outcome 2. The mean difference in the score (number of correct answers) for all of the questions that assess their ability to apply the 12 concepts that are included in the IHC primary school resources After 9 weeks
Secondary Outcome 1. The difference between the intervention and control groups in the proportion of children with a score indicating mastery of the concepts Nine weeks. After one year.
Secondary Outcome 2. The difference between the intervention and control groups for each concept and for the questions intended to measure their understanding of the concepts Nine weeks. After one year.
Secondary Outcome 3. Differences in intended behaviours and self-efficacy After nine weeks. After one year
Secondary Outcome 4. Differences in attitudes towards science and school attendance using daily class registers. After nine weeks
Primary Outcome The mean difference in the score between the intervention and control groups. After 9 weeks. After one year.
Secondary Outcome The difference in the proportion of children with a passing score in a subgroup of children who completed the audio version of the test in Luganda After 9 weeks.
Secondary Outcome The difference in attendance and academic achievement as indicated by school marks Before 9 weeks of the trial (Academic Term I- 2016) During 9 weeks of the trial (Academic Term II- 2016) After 9 weeks of the trial (Academic Term III- 2016).
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Makerere University College of Health Sciences P.O.Box 7072, New Mulago Hospital Complex, Office Clinical Trials Building (Level 3) Kampala 00256 Uganda
FUNDING SOURCES
Name of source Street address City Postal code Country
The Research Council of Norway P.O Box 564 N-1327 Lysaker, Visiting Address: Drammensveien 288, 0283 Oslo Oslo N-1327 Norway
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Norwegian Institute of Public Health PO Box 4404 Nydalen N-0403 Oslo Oslo N-0403 Norway Funding Agency
COLLABORATORS
Name Street address City Postal code Country
Makerere University P.O.Box 7062 Kampala 256 Uganda
Great Lakes University, Kisumu Turn off Kisumu - Kakamega/Vihiga Road - Towards, but Past Mamboleo and Guba 1/4 KMS from KESREF (Kenya Sugar Research Foundation) Kisumu P.O.Box 2224-40100 Kenya
University of Rwanda Butare Butare RN1, Butare, Rwanda Rwanda
James Lind Intitiative Summertown Pavillion, Middle Way, Oxford OX2 7LG United Kingdom
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Andrew David Oxman oxman@online.no +4748254924 PO Box 4404 Nydalen N-0403 Oslo
City Postal code Country Position/Affiliation
Oslo N-0403 Norway Research Director
Role Name Email Phone Street address
Public Enquiries Allen Nsangi nsallen2000@yahoo.com +256773333629 Plot 15 Kampala Road
City Postal code Country Position/Affiliation
Kampala 256 Uganda Research Fellow
Role Name Email Phone Street address
Scientific Enquiries Nelson Kaulukusi Sewankambo sewankam@infocom.co.ug +256782366751 P.O.Box 7062
City Postal code Country Position/Affiliation
Kampala 00256 Uganda
REPORTING
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