Abstract
BACKGROUND: People living with diabetes can reduce their risk of vision loss from diabetic retinopathy by attending screening, which enables early detection and timely treatment. The aim of this pilot trial was to assess the feasibility of a full-scale cluster randomized controlled trial of an intervention to increase uptake of retinal examination in this population, as delivered within existing community-based diabetes support groups (DSGs). METHODS: All 16 DSGs in Kirinyaga county were invited to participate in the study. The first two groups recruited took part in the pilot trial. DSG members who met the eligibility criteria were recruited before the groups that were randomized to the two arms. In the intervention group, two peer educators were trained to deliver monthly DSG-based eye health education and individual telephone reminders to attend screening. The control group continued with usual DSG practice which is monthly meetings without eye health education. The recruitment team and outcome assessors were masked to the allocation. We documented the study processes to ascertain the feasibility, acceptability, and potential effectiveness of the intervention. Feasibility was assessed in terms of clarity of study procedures, recruitment and retention rates, level of acceptability, and rates of uptake of eye examination. We set the target feasibility criteria for continuation to the main study to be recruitment of 50 participants in the trial, 80% monthly follow-up rates for individuals, and no attrition of clusters. RESULTS: Of the 122 DSG members who were assessed for eligibility, 104 were recruited and followed up: 51 (intervention) and 53 (control) arm. The study procedures were well understood and easy to apply. We learnt the DSG meeting days were the best opportunities for recruitment. The study had a high acceptance rate (100% for clusters, 95% for participants) and high follow-up and retention rate (100% of those recruited). All clusters and participants were analysed. We observed that the rate of incidence of eye exam was about 6 times higher in the intervention arm as compared to the control arm. No adverse unexpected events were reported in either arm. CONCLUSIONS: The study is feasible and acceptable in the study population. The results support the development of a full-scale cluster RCT, as the success criteria for the pilot were met. TRIAL REGISTRATION: Pan African Clinical Trials Registry PACTR201707002430195 Registered on 25 July 2017.