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.
ABSTRACT
BACKGROUND: All patients with diabetes are at risk of developing diabetic retinopathy (DR), a progressive and potentially blinding condition. Early treatment of DR prevents visual impairment and blindness. The natural history of DR is that it is asymptomatic until the advanced stages, thus annual retinal examination is recommended for early detection. Previous studies show that the uptake of regular retinal examination among people living with diabetes (PLWD) is low. In the Uptake of Retinal Examination in Diabetes (DURE) study, we will investigate the effectiveness of a complex intervention delivered within diabetes support groups to increase uptake of retinal examination. METHODS: The DURE study will be a two-arm pragmatic cluster randomized clinical trial in Kirinyaga County, Kenya. Diabetes support groups will be randomly assigned to either the intervention or usual care conditions in a 1:1 ratio. The participants will be 700 PLWD who are members of support groups in Kirinyaga. To reduce contamination, the unit of randomization will be the support group. Peer supporters in the intervention arm will receive training to deliver the intervention. The intervention will include monthly group education on DR and individual member reminders to take the eye examination. The effectiveness of this intervention plus usual care will be compared to usual care practices alone. Participant data will be collected at baseline. The primary outcome is the proportion of PLWD who take up the eye examination at six months. Secondary outcomes include the characteristics of participants and peer supporters associated with uptake of eye examination for DR. Intention-to-treat analysis will be used to evaluate the primary and secondary outcomes. DISCUSSION: Eye care programs need evidence of the effectiveness of peer supporter-led health education to improve attendance to retinal screening for the early detection of DR in an African setting. Given that the intervention combines standardization and flexibility, it has the potential to be adopted in other settings and to inform policies to promote DR screening. TRIAL REGISTRATION: Pan African Clinical Trial Registry PACTR201707002430195 , registered 25 July 2017, www.pactr.org.
