Contact information
Type
Scientific
Primary contact
Dr Anthony Hall
ORCID ID
Contact details
Eye Department
Kilimanjaro Christian Medical Centre
PO Box 3010
Moshi
.
Tanzania
abhall@kcco.net
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
A randomised controlled trial of screening strategies for diabetic retinopathy in Kilimanjaro region: a randomised controlled trial of the effect of a screening camera on uptake of screening for diabetic retinopathy (phase I) and a randomised controlled trial of the effect of mobile telephone text reminders of screening appointments on uptake of screening for diabetc retinopathy (phase II)
Acronym
Study hypothesis
Diabetes is a growing problem in Sub Saharan Africa. The number of diabetics in Eastern Africa is expected to reach 1.4 million by 2025. A high proportion of these patients develop sight threatening diabetic retinopathy. Uptake of screening for retinopathy is very poor throughout the region. We hypothesise that taking screening to the patients in diabetic clinics rather than asking them to go to an eye clinic and telephoning them prior to the screening appointment will lead to improvements in the uptake of screening.
Ethics approval
Tumaini University (Tanzania) Ethics Committee approved in January 2009 (ref: 241)
Study design
Single centre randomised interventional screening trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Diabetes mellitus, diabetic retinopathy
Intervention
Phase I:
1. Intervention group: A digital diabetic retinopathy screening camera will be placed in the diabetic clinic at KCMC
2. Control group: patients will be advised to go to the eye clinic at KCMC for a dilated screening examination by an ophthalmologist
3. All patients will receive 3 information leaflets on diabetic retinopathy and be counselled by the health workers in the diabetic clinic that they should have screening for diabetic retinopathy
4. Visual acuity measurement will be performed and dilating drops installed by the screening team
Phase II:
1. The retinopathy screening camera will go to all district diabetic clinics twice in the 6 month intervention period
2. Patients registered at these clinics will all be advised by clinic staff to attend for retinopathy screening
3. The intervention group will receive a text message by mobile phone advising them of the date of the screening and inviting them to come
Intervention type
Other
Phase
Phase I/II
Drug names
Primary outcome measures
Uptake of screening for diabetic retinopathy, measured in August 2011
Secondary outcome measures
Measured in January 2012:
1. Prevalence of diabetic retinopathy in urban and rural diabetic patients in Kilimanjaro region
2. Prevalence of cataract in urban and rural diabetic patients in Kilimanjaro region
Overall trial start date
10/12/2010
Overall trial end date
31/07/2011
Reason abandoned
Eligibility
Participant inclusion criteria
All known adult diabetic patients resident in Kilimanjaro region and attending a diabetic clinic at Kilimanjaro Christain Medical Centre (KCMC) or at one of the district diabetic clinics in the 6 rural districts of Kilimanjaro region
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Phase 1: 250; phase II: 500
Participant exclusion criteria
1. Diabetic patients from outside Kilimanjaro region attending the above clinics
2. Refusal or withdrawal of consent
3. Psychiatric illness preventing screening examination
4. Patients too ill on the day of screening to have an eye examination
Recruitment start date
10/12/2010
Recruitment end date
31/07/2011
Locations
Countries of recruitment
Tanzania
Trial participating centre
Eye Department
Moshi
.
Tanzania
Sponsor information
Organisation
Christoffel Blinden Mission (CBM) e.V. (Germany)
Sponsor details
Nibelungenstrasse 124
Bensheim
D-64625
Germany
Sponsor type
Charity
Website
Funders
Funder type
Charity
Funder name
Christoffel Blinden Mission (CBM) e.V. (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
AusAid (Australia)
Alternative name(s)
AusAID
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
Australia
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary