BACKGROUND Young adults with type 2 diabetes (aged 18-39 years) are at risk of early onset and rapid progression of diabetic retinopathy, the leading cause of blindness and vision loss in working age adults. Early detection via retinal screening can prevent most vision loss, yet screening rates are consistently lower among this priority population than the general diabetes population. We aimed to test the effect of a tailored, evidence-based brief health behaviour change intervention (leaflet) on self-reported screening uptake, and previously identified social cognitive determinants of retinal screening. METHODS A pragmatic, two-arm randomised controlled trial was conducted from September 2014 to April 2015. Participants were stratified by prior screening uptake (Yes/No) and randomly allocated to intervention (leaflet) or 'usual care' control (no leaflet). Primary outcome was self-reported screening uptake four weeks post-intervention for 'No' participants who had not previously screened for diabetic retinopathy. Secondary outcome variables were changes in knowledge, attitudes, normative beliefs, intention and behavioural skills for all participants, irrespective of prior screening behaviour. To assess intervention effects on secondary outcome variables, we conducted independent samples t-tests (two-tailed) on pre-post change scores. RESULTS 129 young adults (26% no prior retinal screen) completed baseline; 101 completed post-intervention. Power to determine effect on the primary outcome was curtailed by low recruitment of individuals with no prior retinal screen and loss to follow-up. Attrition was associated significantly with country of birth, language spoken at home, and marital status. Significant intervention effect was observed for one secondary outcome variable: knowledge of diabetic retinopathy (p = .03) with moderate effect (partial eta squared η2 = .05); no adverse effects were reported. Control group participants received the leaflet at study completion. CONCLUSIONS This study confirms that a well-designed eye health and retinal screening promotion leaflet can increase knowledge of diabetic retinopathy, an important screening predictor. The study highlights the challenges of conducting 'real-world' health behaviour change research with this priority population, providing insights for clinicians and researchers. Strategies to recruit, engage and retain hard-to-reach populations are discussed including nonconventional alternatives to randomised controlled trial designs. TRIAL REGISTRATION ACTRN12614001110673, UTN No.: U1111-1161-9803. Registered 20 October 2014 - retrospectively registered https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=367127.

中文翻译：

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量身定制的传单在2型糖尿病年轻人中促进糖尿病性视网膜病变筛查的效果：一项随机对照试验。

背景技术患有2型糖尿病的年轻人（年龄在18-39岁之间）处于糖尿病性视网膜病的早期发作和快速发展的风险中，糖尿病性视网膜病是工作年龄的成年人失明和视力丧失的主要原因。通过视网膜筛查及早发现可以预防大多数视力丧失，但该优先人群的筛查率始终低于普通糖尿病人群。我们旨在测试量身定制的，循证的简短健康行为改变干预措施（传单）对自我报告的筛查摄取的影响，以及先前确定的视网膜筛查的社会认知决定因素。方法2014年9月至2015年4月进行了实用的两臂随机对照试验。参与者按照事先筛查的摄取量（是/否）进行分层，并随机分配至干预措施（传单）或“常规护理” 对照（无传单）。主要结局是干预后四周自我报告的筛查摄入量，这些参与者以前没有筛查糖尿病性视网膜病的“否”参与者。次要结果变量是所有参与者的知识，态度，规范性信念，意图和行为技能的变化，而与先前的筛查行为无关。为了评估干预对次要结果变量的影响，我们对事前变更分数进行了独立的样本t检验（两尾）。结果129名青年人（未进行视网膜筛查的人群为26％）完成了基线；101个干预后完成。较低的个体招募人数，没有事先进行视网膜筛查和随访失败的因素削弱了确定对主要结果的影响的能力。减员与出生国显着相关，在家说的语言和婚姻状况。对于一个次要结果变量，观察到了显着的干预效果：对糖尿病性视网膜病变的了解（p = .03），具有中等效果（偏η平方η2= .05）；没有不良反应的报道。对照组参与者在研究完成时收到了传单。结论这项研究证实，精心设计的眼睛健康和视网膜筛查促进传单可以增加对糖尿病性视网膜病（一种重要的筛查指标）的了解。该研究强调了在这一优先人群中开展“现实世界”健康行为改变研究的挑战，为临床医生和研究人员提供了见识。讨论了招募，吸引和留住难以到达的人群的策略，包括随机对照试验设计的非常规替代方案。试用注册号ACTRN12614001110673，UTN编号：U1111-1161-9803。2014年10月20日注册-追溯注册https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=367127。