Condition category
Nutritional, Metabolic, Endocrine
Date applied
23/01/2011
Date assigned
02/06/2011
Last edited
02/06/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.cbm.de

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

Publication citations

Additional files

Editorial Notes