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临床试验/NCT02339909
NCT02339909已完成不适用

Incentives in Diabetic Eye Assessment by Screening (IDEAS) Trial

Imperial College London0 个研究点目标入组 1,051 人开始时间: 2015年3月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
1,051
主要终点
Number of Patients Attending Screening Appointment

研究概览

简要总结

This trial is a randomised controlled trial to assess whether annual attendance rates at diabetic eye screening appointments in Kensington, Chelsea and Westminster could be improved by offering invitees a small financial incentive. The research questions are:

  1. Are incentives an effective strategy to encourage participation in the screening programme?
  2. Does the design of the financial incentive scheme affect its effectiveness in influencing participation in health screening?
  3. Does the choice of incentive scheme, if successful, attract patients who have a different demographic or socioeconomic status to those who attend screening regularly?
  4. Is offering these incentives a cost-effective strategy for enhancing participation?

详细描述

An increasing emphasis is being placed on preventative healthcare in the NHS (National Health Service). Screening programmes currently exist in many clinical areas including diabetic retinopathy as well as breast cancer, cervical cancer and cardiovascular disease. In many contexts the benefits of health screening are well documented, but concerns exist about the effectiveness and cost-effectiveness of such programmes as uptake to screening may be very poor in some, generally hard to reach, communities. There are many ways of trying to encourage participation in health promoting activities and it is likely real shifts in behaviour will only come about with a mix of strategies. In this study we set out to see if we can improve screening rates in London, which has both high and low levels of deprivation and specific populations with poor attendance. The ultimate success of a high-quality screening program depends on the uptake rate of the population and novel solutions are required to meet the challenge of achieving this.

Diabetes is an increasing public health concern worldwide. There are 2.9 million people diagnosed with diabetes in the UK (United Kingdom) and an estimated 850,000 people who have the condition but are not recognised. Whilst the rates of other vascular risk factors such as hypertension, smoking and hypercholesterolaemia are falling, the rates of diabetes in the UK are rising. This is despite the co-ordinated efforts of primary and secondary care prevention programmes.

All patients with diabetes are at risk of developing diabetic retinopathy. This condition is caused by the microscopic damage to small blood vessels to the eye. There is proliferation (growth) of these vessels and these new fragile vessels may bleed and destroy the retina leading to sight loss. It is estimated that in England every year 4,200 people are at risk of blindness caused by diabetic retinopathy and there are 1,280 new cases of blindness caused by diabetic retinopathy. It is the leading cause of sight loss in the UK in the working population and therefore there is a significant social and financial burden associated with the condition. However with timely diagnosis and treatment the risk of blindness can be dramatically reduced. As this condition may well remain silent until catastrophic late manifestations of the disease are evident, the need for an effective screening programme is obvious.

The National Screening programme was implemented in England between 2003 and 2006. This involves an annual retinal digital photographic screening offered to all people aged 12 years and older diagnosed with type 1 and type 2 diabetes. The test involves administration of eye drops to the eye and a photograph of the retina taken without contact with the eye. The success of this screening programme is without contest. In 2011-2012, 2,587,000 people in England aged 12 and over were identified with diabetes and over 90% were offered screening for diabetic retinopathy. 1,911,000 received screening which equates to an uptake of 81%. However there is significant variability in uptake in differing areas.

Although screening is offered in multiple locations including GP (general practice) surgeries and hospitals, the poor uptake of screening in socially deprived areas is well documented. For example, in Gloucestershire, with each increasing quintile of deprivation, diabetes prevalence increases (odds ratio 0.84), the probability of having been screened for diabetic retinopathy decreases (odds ratio 1.11), and the prevalence of sight-threatening diabetic retinopathy among screened patients increases also (odds ratio of 0.98).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
None

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diabetic patients who were invited to screening in the last 24 months on a yearly basis and failed to attend or contact the screening service to rearrange an appointment

排除标准

  • 未提供

研究组 & 干预措施

Probabilistic Incentive

Experimental

The intervention for the "probabilistic incentive" group consists of the standard invitation letter from the Screening service, with additional text offering a probabilistic financial incentive (entry into a lottery offering at least a 1 in 100 chance to win £1000) if they attend screening. (The trial is testing the impact of the different invitation letters on the primary outcome of screening attendance.)

干预措施: Probabilistic financial incentive (Behavioral)

Control

Active Comparator

The intervention for the "Control" group consists of the standard invitation letter from the Screening service. (The trial is testing the impact of the different invitation letters on the primary outcome of screening attendance.)

干预措施: Control (Behavioral)

Fixed Incentive

Experimental

The intervention for the "fixed incentive" group consists of the standard invitation letter from the Screening service, with additional text offering a fixed financial incentive (£10) if they attend screening. (The trial is testing the impact of the different invitation letters on the primary outcome of screening attendance.)

干预措施: Fixed financial incentive (Behavioral)

结局指标

主要结局

Number of Patients Attending Screening Appointment

时间窗: At designated appointment date (between three months and one year from previous missed appointment)

The participants will be invited to a specific appointment between three months and one year from their previous missed appointment. The primary outcome refers to the number of participants who did attend their appointment.

次要结局

  • Number of Patients Requiring Intervention After Sight Outcome From Diabetic Retinopathy Screening.(Number of patients with additional management triggered as a result of test at designated screening appointment (between three months and one year))

研究者

申办方类型
Other
责任方
Sponsor

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