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.: PACTR201609001789310 Date of Approval: 20/09/2016
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Schools and Young People with Sickle Cell Disease (SCD) in Nigeria
Official scientific title Schools and Young People with Sickle Cell Disease (SCD) in Nigeria
Brief summary describing the background and objectives of the trial Sickle cell disease (SCD) is an inherited multi-system disorder that affects millions of people worldwide. Over 80% of people with SCD are born in Africa. In Nigeria, by far the most populous country in Africa, one in five of the population are carriers of SCD and the there are about 20 sickle cell anemiaper 1000 births. Review of scientific interventions show comparative little attention to SCD in Africa. In other words, SCD is an important but relatively neglected public health issue in Africa. In the UK, work by DMU examined care among young people with SCD in schools and the consequence of this is a publication, Guide to School Policy on Sickle Cell. This guide, tranlated into Nigerian major languages, has been adapted to the situation in Nigeria. This study aims to evaluate the effectiveness of introducing a formal Guide to School Policy on Sickle Cell on: (1) the reported health-related experiences of young people with sickle cell disease (SCD) (2) the attitudes of teachers towards pupils with SCD
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Haematological Disorders,Sickle Cell Disease
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 30/09/2016
Actual trial start date 30/09/2016
Anticipated date of last follow up 20/07/2017
Actual Last follow-up date 20/09/2016
Anticipated target sample size (number of participants) 400
Actual target sample size (number of participants) 400
Recruitment status 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 Simple randomization sequence using Table of Random Numbers The allocation sequence was done by a LASUCOM statistician who is situated off site Masking/blinding used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization sequence using Table of Random Numbers The allocation sequence was done by a LASUCOM statistician who is situated off site Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group School Guide on Sickle Cell Policy One session educational workshop One day schools where theSchool staff will undergo an educational session on sickle cell delivered by a member of the research team, based on information in the Guide to School Policy 200 Placebo
Control Group Standard School Health Education Weekly 6 months Standard School Health Education provided in the schools 200 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Ages: 5-18 living with sickle cell disease (sickle cell anaemia; haemoglobin SC disease, sickle beta-thalassaemia or other forms of sickle cell disease, but not sickle cell trait [haemoglobin AS]) 2. Attending the outpatient sickle cell clinics at Lagos State University College of Medicine and/or the Lagos sickle cell support clubs, 3. Assent (with parental consent), or (aged 16+) who consent, to take part. Those on inpatient admissions Those who are too sick to participate in the study Those who do not consent or assent to the study 5 Year(s) 18 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 10/11/2015 Health Research and Ethics Committee
Ethics Committee Address
Street address City Postal code Country
1-3 Oba Akinjobi Way Ikeja Nigeria
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 18/09/2015 Faculty Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
The Gateway Leicester LE1 9BH United Kingdom
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome composite score out of ten based on the ten test items (some score 1 point for a yes, some score 1 point for a no depending upon whether the item in question represents a support to good health or a threat to good health) 6 months post-intervention
Secondary Outcome Number of days off school 6 months post intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Lagos University Teaching Hospital 1 Idi Araba Surulere Nigeria
Lagos State University Teaching Hospital 1-3 Oba Akinjobi Way Ikeja Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
De Montfort University The Gateway Leicester LE1 9BH United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor De Montfort University The Gateway Leicester LE1 9BH United Kingdom University
Secondary Sponsor LASUCOM 1-3 Oba Akinjobi Way Ikeja Nigeria University
COLLABORATORS
Name Street address City Postal code Country
Simon Dyson The Gateway Leicester LE1 9BH United Kingdom
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Bolanle Ola wobola@yahoo.com +2347033429007 1-3 Oba Akinjobi Way
City Postal code Country Position/Affiliation
Ikeja Nigeria Senior Lecturer/LASUCOM
Role Name Email Phone Street address
Public Enquiries Bolanle Ola wobola@yahoo.com +2347033429007 1-3 Oba Akinjobi Way
City Postal code Country Position/Affiliation
Ikeja Nigeria Senior Lecturer/LASUCOM
Role Name Email Phone Street address
Scientific Enquiries Bolanle Ola wobola@yahoo.com +2347033429007 1-3 Oba Akinjobi Way
City Postal code Country Position/Affiliation
Ikeja Nigeria Senior Lecturer/LASUCOM
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information