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.: PACTR201503001049236 Date of Approval: 27/02/2015
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Peek school screening Project
Official scientific title smartphone vision testing of school children in Transzoia county Kenya: A randomised Controlled Trial
Brief summary describing the background and objectives of the trial Tackling childhood blindness is one of the main priorities of the VISION2020 initiative, that aims to reduce the prevalence of childhood blindness and to ensure that all school going children have vision screening which should be integrated in school health programmes by year 2020. In parts of the world, teachers or school-based nurses are trained to screen for low vision in schools, however the screening is not universal especially in Kenya. The accuracy of visual acuity measurement from some teachers has been variable. Similarly, Eye health systems are under resourced and eye health providers are required to travel to schools and examine all children to identify those with impairment. Eye units typically close to accommodate the outreach in schools whilst the eye health care worker is not in the hospital, thereby reducing the hospital¿s capacity. Peek visual acuity is a smartphone based vision test that offers a fast vision-testing algorithm that allows visual acuity to be measured accurately, precisely and reliably within an acceptable period of time. The Peek system also auto generates a referral to the hospital and is able to flag non-attenders and send a personalized Short Message Services (SMS) to the school and carer to remind them of the referral. it is envisaged that teachers would use the Peek device to deliver screening, freeing up eye care workers to concentrate on patients in the hospitals. The aim of this trial is to determine if the Peek Vision screening and referral system increases the proportion of children detected in schools as having low vision attending the hospital for assessment compared to current standards. Objectives 1. What proportion of children with VI identified and referred using Peek attended the referral hospital? 2. What proportion of children with Visual Impairment VI identified and referred using snellen Tumbling E and paper referral (current standard of care) attended the referral hospital?
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Eye Diseases,VISUAL IMPAIREMENT
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Early detection /Screening
Anticipated trial start date 03/03/2015
Actual trial start date 02/03/2015
Anticipated date of last follow up 06/05/2015
Actual Last follow-up date 07/05/2015
Anticipated target sample size (number of participants) 1000
Actual target sample size (number of participants) 897
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
FAN: IREC 1359 INSTITUTIONAL RESEARCH AND ETHICS COMMITTEE
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 was used. Stratification allocated allocated schools based to zones and proximity and direction to the referral hospital. Allocation was determined by the holder of the sequence who is off site Masking/blinding used
Parallel: different groups receive different interventions at same time during study Randomised stratified allocation was used. Stratification allocated allocated schools based to zones and proximity and direction to the referral hospital. Allocation was determined by the holder of the sequence who is off site Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Peek Arm Vision will be assessed using the Peek visual acuity app. Those who have impaired vision will be shown a live simulation of their vision and normal vision on the Smartphone and Peek will auto generate a text message advising the carer that the child needs to seek assistance. A referral will automatically be sent to the Hospital. Non-attenders will be sent reminder SMSs periodically. 500
Control Group standard Arm (Tumbling E) vision will be assessed using the standard Tumbling E Chart. Standard methods of referral will be followed as follows; a child with low vision will be given a letter to the career which will be presented to the hospital 500
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All children in selected schools for whom head teachers and parents have given consent 1. Child unable or unwilling to give verbal Assent 2. School students whose parents/guardians do not provide consent 6 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 23/02/2015 INSTITUTIONAL RESEARCH AND ETHICS COMMITEE (IREC)
Ethics Committee Address
Street address City Postal code Country
MOI TEACHING AND REFERAL HOSPITAL, NANDI ROAD ELDORET 30100100 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The proportions of early attenders, late attenders and non-attenders in each intervention arm. Distance from school to hospital will be considered as a potential explanatory variable. The primary end point is participants who attend the hospital within 2 months of referral. Any child who attends the hospital appointment within 4 weeks of the examination date will be considered an ¿ early attender¿ Child attends who attends after four weeks but before the study closes will be a ¿late attender¿. A child who does not attend the appointment is referred to as ¿non attender¿.
Secondary Outcome the secondary analysis will include mean time taken to Hospital. The mean and the 95% confidence interval will be calculated in each arm for comparison. Kaplan-Meier analysis will be used to plot survival curves to the final visit at 2 months at each intervention arms.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
KITALE HOSPITAl and TRANsZOIA COUNTY Kitale Kapenguria Road kitale 30200 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
SEEING IS BELIEVING 8th Floor, 1 Basinghall Ave. London EC2V 5DD United Kingdom
SEEING IS BELIEVING AND STANDARD CHARTED BANK 8th Floor, 1 Basinghall Ave. London EC2V 5DD United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor London School of Hygiene and Tropical Medicine Keppel street london WC1E 7HT United Kingdom University
COLLABORATORS
Name Street address City Postal code Country
OPERATION EYE SIGHT UNIVERSAL- KENYA Regent Court Management Block A7, Arwings Khodek Rd NAIROBI 00200
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator MATTHEW BURTON Matthew.Burton@lshtm.ac.uk +44 (0)20 7927 2329 KEPPEL STREET
City Postal code Country Position/Affiliation
LONDON WC1E 7HT United Kingdom INTERNATIONAL CENTRE FOR EYE HEALTH, LONDON SCHOOL OF HYGIENE AND TROPICAL MEDICINE
Role Name Email Phone Street address
Public Enquiries HILLARY RONO hkrono75@gmail.com +254722627207 KITALE HOSPITAL EYE UNIT , KITALE KAPENGURIA RD
City Postal code Country Position/Affiliation
KITALE 30200 Kenya OPTHALMOLOGISTS, MINISTRY OF HEALTH, TRANSZOIA COUNTY
Role Name Email Phone Street address
Public Enquiries HILLARY RONO hkrono75@gmail.com +254722627207 KITALE HOSPITAL EYE UNIT , KITALE KAPENGURIA RD
City Postal code Country Position/Affiliation
KITALE 30200 Kenya OPTHALMOLOGISTS, MINISTRY OF HEALTH, TRANSZOIA COUNTY
Role Name Email Phone Street address
Scientific Enquiries Andrew Bastawrous andrew.bastawrous@googlemail.com +44(0)207 958 8343 KEPPEL STREET
City Postal code Country Position/Affiliation
LONDON WC1E 7HT United Kingdom INTERNATIONAL CENTRE FOR EYE HEALTH, LONDON SCHOOL OF HYGIENE AND TROPICAL MEDICINE (LSHTM)
REPORTING
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