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 |
| Protocol serial number | N/A |
| Sponsor | Christoffel Blinden Mission (CBM) e.V. (Germany) |
| Funders | Christoffel Blinden Mission (CBM) e.V. (Germany), AusAid (Australia) |
- 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
Scientific
Eye Department
Kilimanjaro Christian Medical Centre
PO Box 3010
Moshi
.
Tanzania
| Phone | No telephone contact available |
|---|---|
| abhall@kcco.net |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single centre randomised interventional screening trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| 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) |
| Study objectives | 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(s) | Tumaini University (Tanzania) Ethics Committee approved in January 2009 (ref: 241) |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
Uptake of screening for diabetic retinopathy, measured in August 2011 |
| Key secondary outcome measure(s) |
Measured in January 2012: |
| Completion date | 31/07/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 750 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 10/12/2010 |
| Date of final enrolment | 31/07/2011 |
Locations
Countries of recruitment
- Tanzania
Study participating centre
Eye Department
Moshi
.
Tanzania
.
Tanzania
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan | Not 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 |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
23/05/2022: Publication references added.
