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.: PACTR201707002430195 Date of Approval: 15/07/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Diabetic Retinopathy in Kenya: Uptake of Retinal Examination in patients with Diabetes Mellitus (DURE) study
Official scientific title Diabetic Retinopathy in Kenya: Uptake of Retinal Examination in patients with Diabetes Mellitus (DURE) study
Brief summary describing the background and objectives of the trial Diabetic retinopathy (DR) is a leading cause of visual impairment and blindness. Sight loss from DR causes a significant burden on the individual patient, their families, service providers and the health system. All patients with diabetes are at risk of DR.The recommendation is that such patients should have an annual eye examination in order to detect DR early enough. Previous studies have shown that that the adherence to this recommendation is low. Interventions to improve compliance with recommendations for regular eye examination are thus a priority. The aim of the study is to investigate whether a community level peer support intervention can empower people living with diabetes to undergo an annual retinal examination.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) DURE
Disease(s) or condition(s) being studied Diabetic Retinopathy,Eye Diseases,Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 15/09/2017
Actual trial start date 15/09/2017
Anticipated date of last follow up 31/12/2018
Actual Last follow-up date 31/12/2018
Anticipated target sample size (number of participants) 700
Actual target sample size (number of participants) 700
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
QA973 LSHTM Sponsor Confirmation
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 Patient support groups will be allocated to the intervention and control arms. A computer-generated allocation sequence will be provided by a statistician who is not involved in the field work. Patient support groups will be the strata for allocation. Randomization will be at the cluster level (patient support group).Recruitment will be conducted by a research nurse who is masked to the randomization sequence. After recruitment, the allocation determined by an off-site statistician will be revealed on telephone. Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Community-based peer education support The intervention arm will receive a monthly group talk on diabetic retinopathy and a monthly telephone call reminder to undergo an eye examination, in addition to usual care. one year The intervention arm will receive a monthly group talk on diabetic retinopathy and a monthly telephone call reminder to undergo an eye examination, in addition to usual care. The peer supporters will receive a weekly telephone call for support. 350 Active-Treatment of Control Group
Control Group usual care usual care one year The group will continue with the usual standard of care 350
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Participants 1. The participant will reside in Kirinyaga for the next 12 months 2. The participant is a member of a patient support group in Kirinyaga 3. The participant living with diabetes 4. The participant age 18 years or older 5. The participant willing to participate in the study 6. The participant has a mobile phone Peer supporters In addition to the above criteria: 1.The participant willing to participate in the study as a peer supporter 2. Has had an eye examination in the last 12 months 3. Is proficient in Kiswahili or Kikuyu? 4. Is willing to commit 2 days for training and many hours supporting participants over the next 12 months 5. Has a mobile phone 1. Participant is pregnant 2. Participant is breastfeeding 3. Participant has previously been enrolled and randomized into this study 4. Participant is taking part in another study 5. Participant has a debilitating medical or related condition 6. Participant has received previous ophthalmological treatment for diabetic retinopathy 7. Participant been seen by an ophthalmologist for a retinal examination within the last 12 months 18 Year(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 05/06/2017 LSHTM Ethics
Ethics Committee Address
Street address City Postal code Country
Keppel Street London 12345 United Kingdom
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome will be the proportion of participants in each arm that take up eye examination for detection of diabetic retinopathy 6 months 1 year
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kirinyaga community support groups Support group meeting points Kirinyaga County BOX 2, 00202 Kenya
Kirinyaga community support groups Box 2, 00202 NAIROBI 00202 Kenya
Registration centre 1 Box 2, 00202 NAIROBI 00202 Kenya
Kirinyaga community support groups Support group meeting points Kirinyaga County BOX 2, 00202 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
QUEEN ELIZABETH DIAMOND JUBILEE TRUST / COMMUNITY EYE HEALTH CONSORTIUM Keppel Street London WC1E 7HT 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
College of Ophthalmology of Eastern, Central and Southern Africa Regent Court, Block A, Suite A7 NAIROBI 00100 Kenya
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator NYAWIRA MWANGI Nyawira.Mwangi@lshtm.c.uk +254 722 727839 BOX 2, 00202
City Postal code Country Position/Affiliation
NAIROBI 00202 Kenya LSHTM/KMTC
Role Name Email Phone Street address
Public Enquiries Nyawira Mwangi Nyawira.Mwangi@lshtm.ac.uk +254722727839 Box 2, 00202
City Postal code Country Position/Affiliation
Nairobi 00202 Kenya LSHTM
Role Name Email Phone Street address
Scientific Enquiries ALLEN FOSTER Allen.Foster@lshtm.ac.uk +44 (0)20 7958 8345 Keppel Street
City Postal code Country Position/Affiliation
London WC1E 7HT United Kingdom LSHTM
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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
Trial Information Trial phase 06/07/2018 PACTR UPDATE Not Applicable
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 16/07/2018 updated status Not yet recruiting Recruiting
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 24/06/2019 Study is completed, as planned Recruiting Completed
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Disease(s) 06/07/2018 PACTR UPDATE Other Eye Diseases, Nutritional, Metabolic, Endocrine, Other
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 16/07/2018 Ethics letter uploaded TRUE, LSHTM Ethics, Keppel Street, London, WC1E 7HT, United Kingdom, , 05 Jun 2017, , , TRUE, LSHTM Ethics, Keppel Street, London, 12345, United Kingdom, , 05 Jun 2017, +111111111111, Nyawira.Mwangi@lshtm.ac.uk, 2430_1959_4737.pdf