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临床试验/NCT06058637
NCT06058637已完成不适用

Online Nurse-assisted Eye-screening in Home Healthcare; Implementation Study and Economic Evaluation, From an Individual, Healthcare and Socio-political Perspective

Amsterdam UMC, location VUmc1 个研究点 分布在 1 个国家目标入组 234 人开始时间: 2023年3月23日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
234
试验地点
1
主要终点
Colenbrander-1M visual acuity

研究概览

简要总结

The aim of this study is to investigate the cost-effectiveness of a nurse-assisted online eye-screening in home healthcare in reducing eye complaints.

详细描述

Background:

In the Netherlands, the prevalence of blindness and low vision is highest among the elderly in care institutions and in home healthcare (20-25%). A recent cross-sectional pilot study with one of the largest home healthcare organizations in the Netherlands (i.e. 'Buurtzorg Nederland') showed that simple eye-screening by community nurses helps to detect eye complaints among elderly people living independently. Of all patients who were referred to a general practitioner (GP), optician, optometrist or ophthalmologist based on this screening (20% of the total group), it was found that almost half had severe visual impairment, whereas others had eye complaints that had affected acuity to a smaller extent. In most cases, eye complaints could be treated with spectacles or cataract surgery, but also untreatable eye diseases were found. These complaints may not have been detected without eye-screening and treatment would not have been offered. Often, the elderly themselves or family/friends or care providers, do not recognize that their eyesight has decreased. However, this can negatively affect their quality of life and health status. To increase access to eye care the investigators will perform a study using an online eye screening, which can be performed by the community nurses or possibly the participants themselves in their home environment.

Purpose:

The aim of this study is to investigate the cost-effectiveness of a nurse-assisted online eye-screening in home healthcare in reducing eye complaints.

Method:

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
Single (Investigator)

盲法说明

Research assistants who will perform the measurements after randomisation will be masked.

入排标准

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

入选标准

  • Patients receive home healthcare for health problems
  • 65 years or older
  • Understanding of the Dutch language
  • Cognitive ability to participate in research (six-item Mini Mental State Examination: score >3)

排除标准

  • Very serious health condition of the patient (i.e. terminal illness, receiving palliative home care)
  • Cognitively unable to participate in research (e.g. late stage Alzheimer's/Dementia, Parkinson's) (six-item Mini Mental State Examination: score ≤3)
  • Having received an optometric or ophthalmic consultation within the last 6 months

结局指标

主要结局

Colenbrander-1M visual acuity

时间窗: 12 months

Incidence in clinically relevant change of 2 lines or more on the Colenbrander-1M visual acuity chart

次要结局

  • Colenbrander-1M visual acuity change in participants with baseline visual impairment(12 months)
  • Vision related quality of life with the EyeQ questionnaire(12 months)
  • Amsler grid chart(12 months)
  • Colenbrander-1M visual acuity change(12 months)
  • Fall and fracture calendar(12 months)
  • Wellbeing with the ICEpop CAPability questionnaire(12 months)
  • Optometric status(12 months)
  • Depressive symptomatology measured with the PHQ-9 questionnaire(12 months)
  • Health literacy with the European Health Literacy Survey Questionnaire(12 months)
  • Health related quality of life with the EuroQol 5-Dimension 5-Level questionnaire(12 months)

研究者

发起方
Amsterdam UMC, location VUmc
申办方类型
Other
责任方
Principal Investigator
主要研究者

R.M.A. (Ruth) van Nispen

Prof.dr.

Amsterdam UMC, location VUmc

研究点 (1)

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