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: www.pactr.org
Trial no.: PACTR201807329096632 Date of Approval: 23/07/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Comprehensive Peek Community Eye Health system (Peek CEH system)
Official scientific title Community screening and referral for eye problems using smartphone based algorithms in Trans Nzoia County, Kenya: a cluster randomised controlled trial.
Brief summary describing the background and objectives of the trial Eye care provision is currently insufficient to meet the requirement for eye care services. Many people remain unnecessarily visually impaired due to treatable or preventable eye conditions. Lack of access and awareness of services are key barriers, in large part due to their being too few eye care providers in the health system for the unmet need. Validated smart phone based screening algorithms (Peek Screening app) will be used in this study. The app has an embedded application for measuring visual acuity, combined with an algorithm that enables the Community Volunteer (CVs) to make referral decisions about patients with eye problems. The software manages the data and generates automated SMS messages providers in hospitals and the patients. We will test the hypothesis that by utilizing this novel mobile phone based technology it will be possible to shift eye screening to CVs, and refer patients onwards for primary care without overburdening the health system. We hope that a higher proportion of people with eye problems will be identified using the Peek Screening system, and they will adhere to their referrals and access eye services, compared to those identified and referred using the standard community screening approach.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Eye Diseases,visual impairment and other Eye disease
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 16/07/2018
Actual trial start date 26/11/2018
Anticipated date of last follow up 01/02/2019
Actual Last follow-up date 07/06/2019
Anticipated target sample size (number of participants) 2700
Actual target sample size (number of participants) 13355
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
14633 London School of Hygiene &Tropical Medicine, Observational / Interventions Research Ethics Committee
0003025 Institutional Research And Ethics Committee (IREC), Moi University, Eldoret
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 Dynamic (adaptive) random allocation such as minimization Allocation was determined by the holder of the sequence 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 Peek arm 4 weeks The intervention involves community sensitization with active community screening using Peek community Screening system. Participants will be assessed using Peek Screening app. Those with eye problems will be referred for triage. Peek will auto generate a text message advising the date and place to attend triage. Periodic reminder SMS will be sent. Automatic triage referral will be made 1350
Control Group control arm 4 weeks No active peek screening at the community. Potential participants with eye problems at the community will be notified through community sensitization (posters and local announcements), to present themselves to health facility for the triage clinic on a specified date. 1350 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All People the residing within the community unit Those who consent to participate will be included, Those unwilling to give consent Those with eye conditions treated within 2 weeks prior to the study and have no new eye problems Those on followup at eye hospitals 1 Day(s) 100 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 31/05/2018 Institutional Research And Ethics Committee of Moi University
Ethics Committee Address
Street address City Postal code Country
college of Health Sciences, PO BOX 4606 ELDORET 30100 Kenya
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 09/05/2018 London School of Hygiene and Tropical Medicine Observational Interventions Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Keppel Street LONDON WC1E 7HT 12345 United Kingdom
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The number of people per 10,000 population (rate) attending Triage with any confirmed eye conditions (true positive cases determined at triage by hospital outreach team) following a referral or by self-referral, within four weeks from the time of sensitization in the two arms. 4 weeks
Secondary Outcome The proportion of people referred from the PHC attending their secondary referrals within four weeks of being referred from a PHC. 4 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
KITALE COUNTY AND REFERAL HOSPITAL Kitale Kapenguria Road, P.O BOX 98 KITALE 30200 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
London School of Hygiene & Tropical Medicine Keppel Street LONDON WCIE 7HT United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor London School of Hygiene & Tropical Medicine Keppel Street LONDON WCIE 7HT United Kingdom University
COLLABORATORS
Name Street address City Postal code Country
Kitale County and Referral Hospital Kitale Kapenguria Road, PO BOX 98 KITALE 30200 Kenya
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Matthew Burton Matthew.Burton@lshtm.ac.uk +442079272329 Keppel Street
City Postal code Country Position/Affiliation
LONDON WCIE 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 county and referral Hospital, Eye Unit
City Postal code Country Position/Affiliation
KITALE 30200 Kenya Ophthalmologist Kitale and PhD student LSHTM
Role Name Email Phone Street address
Scientific Enquiries Andrew Bastawrous andrew@peekvision.org +442079588343 Keppel Street
City Postal code Country Position/Affiliation
LONDON WCIE 7HT United Kingdom Peek Vision and International Centre for Eye Health, LONDON SCHOOL OF HYGIENE AND TROPICAL MEDICINE
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
No
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
Section Name Field Name Date Reason Old Value Updated Value
Intervention InterventionTypeID 12/06/2018 clarity Control group Control group
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Target no of participants 12/06/2018 clarity 2700 2500
Section Name Field Name Date Reason Old Value Updated Value
Reporting Plan to share IPD 17/07/2018 new information reqiested No
Section Name Field Name Date Reason Old Value Updated Value
Reporting Results Available 17/07/2018 new information requested No No
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 17/07/2018 uploaded the approval letter TRUE, Institutional Research And Ethics Committee (IREC) of Moi University, college of Health Sciences, PO BOX 4606, ELDORET , 30100, Kenya, , 31 May 2018, , , TRUE, Institutional Research And Ethics Committee of Moi University , college of Health Sciences, PO BOX 4606, ELDORET , 30100, Kenya, , 31 May 2018, +25433471, irecoffice@gmail.com, 3456_2750_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 17/07/2018 The correct postal code WCIE 7HT but the system only accepts numbers. TRUE, London School of Hygiene & Tropical Medicine Observational/ Interventions Research Ethics Committee, Keppel Street, LONDON, WCIE 7HT, United Kingdom, , 09 May 2018, , , TRUE, London School of Hygiene and Tropical Medicine Observational Interventions Research Ethics Committee, Keppel Street, LONDON, 11111, United Kingdom, , 09 May 2018, +442076368636, ethics@lshtm.ac.uk, 3456_2751_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 17/07/2018 THE CORRECT POSTAL CODE IS AFTER THE CITY TRUE, London School of Hygiene and Tropical Medicine Observational Interventions Research Ethics Committee, Keppel Street, LONDON, 11111, United Kingdom, , 09 May 2018, +442076368636, ethics@lshtm.ac.uk, 3456_2751_4737.pdf TRUE, London School of Hygiene and Tropical Medicine Observational Interventions Research Ethics Committee, Keppel Street, LONDON WC1E 7HT, 12345, United Kingdom, , 09 May 2018, +442076368636, ethics@lshtm.ac.uk, 3456_2751_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Public title 17/07/2018 To clarify Peek Community Screening project Comprehensive Peek Community Eye Health system (Peek CEH system)
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial phase 17/07/2018 for clarity Not Applicable
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Disease(s) 17/07/2018 The new fields recently introduced to make the trial clearer Other Eye Diseases, Other
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Target no of participants 17/07/2018 corrections 2500 2700
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 17/07/2018 corection Experimental Group, Peek arm, , , The intervention involves community sensitization with active community screening using Peek community Screening system. Participants will be assessed using Peek Screening app. Those with eye problems will be referred for triage. Peek will auto generate a text message advising the date and place to attend triage. Periodic reminder SMS will be sent. Automatic triage referral will be made , 1250, Experimental Group, Peek arm, , 4 weeks, The intervention involves community sensitization with active community screening using Peek community Screening system. Participants will be assessed using Peek Screening app. Those with eye problems will be referred for triage. Peek will auto generate a text message advising the date and place to attend triage. Periodic reminder SMS will be sent. Automatic triage referral will be made , 1350,
Section Name Field Name Date Reason Old Value Updated Value
Study Design Allocation sequence 17/07/2018 requested in the new system Dynamic (adaptive) random allocation such as minimization
Section Name Field Name Date Reason Old Value Updated Value
Study Design Allocation concealment 17/07/2018 clarification Allocation was determined by the holder of the sequence who is situated off site
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 17/07/2018 the control is usuals Control Group, control arm, , , No active peek screening at the community. Potential participants with eye problems at the community will be notified through community sensitization (posters and local announcements), to present themselves to health facility for the triage clinic on a specified date. , 1250, Control Group, control arm, , 4 weeks, No active peek screening at the community. Potential participants with eye problems at the community will be notified through community sensitization (posters and local announcements), to present themselves to health facility for the triage clinic on a specified date. , 1350, Uncontrolled
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Actual trial start date 20/01/2019 Actual start of the recruitment 26 Nov 2018
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 26/04/2019 started recruiting on the 26.11.2019 Not yet recruiting Recruiting
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 26/04/2019 Recruitment closed on 09/04/2019 . Follow up continues till 5th June 2019 Recruiting Closed to recruitment,follow-up continuing
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Completion date 14/06/2019 Date of the last day of follow added 07 Jun 2019
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Final no of participants 14/06/2019 total number of participants who attended triage repotr 13355
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 14/06/2019 The status of the Trial has changed to completed Closed to recruitment,follow-up continuing Completed