The Kilimanjaro Diabetic Programme: the development of a sustainable regional eye health screening program to prevent blindness among diabetic patients due to diabetic retinopathy

ISRCTN ISRCTN31439939
DOI https://doi.org/10.1186/ISRCTN31439939
Secondary identifying numbers N/A
Submission date
23/01/2011
Registration date
02/06/2011
Last edited
23/05/2022
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Anthony Hall
Scientific

Eye Department
Kilimanjaro Christian Medical Centre
PO Box 3010
Moshi
.
Tanzania

Phone No telephone contact available
Email abhall@kcco.net

Study information

Study designSingle centre randomised interventional screening trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleA 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)
Study objectivesDiabetes 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(s)Tumaini University (Tanzania) Ethics Committee approved in January 2009 (ref: 241)
Health condition(s) or problem(s) studiedDiabetes mellitus, diabetic retinopathy
InterventionPhase 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 typeOther
Primary outcome measureUptake of screening for diabetic retinopathy, measured in August 2011
Secondary outcome measuresMeasured 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 study start date10/12/2010
Completion date31/07/2011

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participantsPhase 1: 250; phase II: 500
Key inclusion criteriaAll 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
Key exclusion criteria1. 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
Date of first enrolment10/12/2010
Date of final enrolment31/07/2011

Locations

Countries of recruitment

  • Tanzania

Study participating centre

Eye Department
Moshi
.
Tanzania

Sponsor information

Christoffel Blinden Mission (CBM) e.V. (Germany)
Charity

Nibelungenstrasse 124
Bensheim
D-64625
Germany

Website http://www.cbm.de
ROR logo "ROR" https://ror.org/04bc8dn02

Funders

Funder type

Charity

Christoffel Blinden Mission (CBM) e.V. (Germany)

No information available

AusAid (Australia)
Government organisation / National government
Alternative name(s)
AusAID
Location
Australia

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing planNot provided at time of registration

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Other publications comic strip development 19/05/2022 23/05/2022 Yes No
Other publications screening programme development 19/05/2022 23/05/2022 Yes No

Editorial Notes

23/05/2022: Publication references added.