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临床试验/NCT03159247
NCT03159247已完成不适用

The eyeGuide: Improving Glaucoma Self-management With a Personalized Behavior Change Program

University of Michigan1 个研究点 分布在 1 个国家目标入组 107 人开始时间: 2017年1月12日最近更新:
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
107
试验地点
1
主要终点
Electronically monitored glaucoma medication adherence

研究概览

简要总结

The purpose of this research study is to test the impact of two personalized technology based programs that may help improve adherence to glaucoma medications.

详细描述

Despite evidence from randomized clinical trials that medication reduces vision loss from glaucoma, it remains the second leading cause of blindness in the United States. A critical barrier to preventing vision loss is that about one-half of glaucoma patients are essentially "untreated" because they do not adhere to their medications. Ineffective self-management behaviors and poor clinical outcomes disproportionately affect the most vulnerable members of US society. The increased burden of glaucoma due to an aging US population, together with a projected shortage of ophthalmologists, will make team-based care essential. There is a critical need to develop and test team-based, personalized behavior change interventions for glaucoma patients to improve medication adherence and the outcomes of care.

Poor adherence to effective medications is a critical barrier to better outcomes in glaucoma patients. The World Health Organization stated that "increasing the effectiveness of adherence interventions may have a far greater impact on the health of the population than any improvement in specific medical treatments." Once diagnosed with glaucoma, at least half of patients do not adhere to their glaucoma medication regimen, return for follow-up, or persist with their medications over the longer term. Patients who are not adherent have more severe visual field loss, which leads to steep declines in health-related quality of life and increased risk of falls and motor vehicle accidents.

Adherence to glaucoma medications is rarely addressed during the clinical encounter because education and counseling programs are not part of standard glaucoma care. Focus groups have demonstrated that patients often have a poor understanding of glaucoma and its treatment. In addition to knowledge gaps, patients have numerous concrete and psychological barriers to managing their glaucoma. In addition, eye drop instillation is rarely taught, and many patients cannot properly instill their medications.

Uniform, scripted approaches to improve adherence do not work. However, complex, individualized counseling interventions, especially those based in motivational interviewing (MI), have improved adherence and health outcomes in many chronic diseases. MI is a style of counseling that engages patients by discussing priorities and obstacles to facilitate intrinsic motivation to change health behavior. Few complex interventions based on these successful principles have been rigorously tested and none implemented into glaucoma care. The eyeGuide is a web-based personally tailored behavior change program based on MI principles, a systematic review of the glaucoma adherence literature, and data from focus groups, surveys and iterative beta-testing with glaucoma patients. It provides individually tailored disease information and support to facilitate MI-based conversations between patients and paraprofessional staff to improve medication adherence. Such technology-based electronic health (eHealth) innovations have great potential to extend the reach of physicians by enabling team-based care.

In this pilot study, the study will test the impact of two personalized eHealth technologies on medication adherence among non-adherent glaucoma patients in a pre-post design: 1) real time automated adherence reminders; and 2) the eyeGuide counseling program. The study will explore the effects of these interventions on secondary outcomes including psychosocial mediators of adherence (e.g. motivation, self-efficacy, satisfaction), intraocular pressure (IOP), and IOP fluctuation.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

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

入选标准

  • •Diagnosis of glaucoma, glaucoma suspect or ocular hypertension
  • •Taking ≥ 1 glaucoma medication
  • •Age ≥ 40 years
  • •Non-adherent to glaucoma medications by both self-report and three months of electronic medication monitoring (adherence ≤ 80%)

排除标准

  • •Cognitive impairment
  • •Severe mental illness
  • •Do not administer own glaucoma medications
  • •Do not speak English

研究组 & 干预措施

eyeGuide

Experimental

Two personalized eHealth interventions aimed to improve glaucoma medication adherence.

干预措施: eyeGuide (Behavioral)

结局指标

主要结局

Electronically monitored glaucoma medication adherence

时间窗: 22 months

electronic medication monitoring

次要结局

  • Change in self-reported medication adherence(22 months)
  • Change in Intra-ocular Pressure Fluctuation(22 months)
  • Proportion of days covered with medication(22 months)
  • Change in eye drop instillation technique(4 months elapsed between 4 month and 8 month site visits)
  • Change in Intra-ocular Pressure(22 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Paula Anne Newman-Casey

Assistant Professor of Ophthalmology and Visual Sciences

University of Michigan

研究点 (1)

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