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临床试验/NCT05667441
NCT05667441已完成不适用

Adherence to Lifestyle Changes for Age-related Macular Degeneration

Erasmus Medical Center1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2021年8月1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
150
试验地点
1
主要终点
Change in lifestyle score

研究概览

简要总结

The AMD-Life study investigates which strategies (personalized risk-profiling including genetic testing and/or coaching) motivate AMD patients to change their lifestyle.

详细描述

Age-related macular degeneration is a frequent eye disease in the elderly affecting the center of retina, i.e., the macula. Despite current treatments for the wet form of this disease, it is still the most frequent cause of blindness in the Western world. The disease is the result of the interplay between genetic and environmental factors such as smoking, unhealthy diet, and lack of physical activity. The current clinical recommendations are aimed towards these lifestyle factors: a healthy diet, no smoking, regular physical exercise, and use of antioxidant supplementation. Although assumed to be low by clinicians as they feel patients find it difficult to actually alter their lifestyle, the adherence and feasibility to these recommendations in clinical ophthalmology practice is unclear. Individualizing the patients' risk of blindness and lifestyle changes, as well as coaching may positively influence adherence strategies. This pilot study aims to gain knowledge and experience in a relatively small study comparing adherence to these strategies through a healthier lifestyle. Additionally, the trial investigates blood and gut microbiome biomarkers: which molecules in blood directly relate to the supplemented nutrients as well as those related to the pathogenesis of AMD, and which biomarkers in blood and eye best correlate with supplement intake and lifestyle.

研究设计

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

入排标准

年龄范围
55 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Early/Intermediate AMD or unilateral late AMD with minimal vision 0.8

排除标准

  • Participation in other intervention studies for AMD
  • Living in retirement homes (difficulty in implementation of diet)
  • Diagnosis of dementia (because of unreliable dietary recall)
  • Persons with macular pathology other than AMD hindering appropriate grading of the macula
  • Persons who are illiterate and have no independent trusted person with them to explain the informed consent form.
  • Persons diagnosed with liver and kidney insufficiency.

研究组 & 干预措施

Standard recommendations + Risk profiling

Active Comparator

The second group (n=50) receives standard care plus personalized risk profiling. A risk scoring based on currently available literature for lifestyle and genetic risk will be used to determine personalized risks of conversion to late AMD. Individuals will be informed about their own risk profile and a personalized strategy will be communicated.

干预措施: Risk profiling (Combination Product)

Standard recommendations + Risk profiling + Additional coaching

Active Comparator

The third group (n=50) receives standard care (see 1); personalized risk profiling (see 2); and coaching. A coach will employ behavioral change techniques (BCT) to enhance adherence using motivational interviews, feedback on behavior; and focus on the advantages of following recommendations.

干预措施: Standard lifestyle recommendations + dietary supplementation (Combination Product)

Standard recommendations + Risk profiling + Additional coaching

Active Comparator

The third group (n=50) receives standard care (see 1); personalized risk profiling (see 2); and coaching. A coach will employ behavioral change techniques (BCT) to enhance adherence using motivational interviews, feedback on behavior; and focus on the advantages of following recommendations.

干预措施: Risk profiling (Combination Product)

Standard recommendations + Risk profiling + Additional coaching

Active Comparator

The third group (n=50) receives standard care (see 1); personalized risk profiling (see 2); and coaching. A coach will employ behavioral change techniques (BCT) to enhance adherence using motivational interviews, feedback on behavior; and focus on the advantages of following recommendations.

干预措施: Coaching (Behavioral)

Standard recommendations

Active Comparator

The first group (n=50) will receive standard care recommendations (according to Netherlands Scientific Society of Ophthalmology 2014, 'Richtlijn Leeftijdsgebonden Maculadegeneratie;): refrain from smoking; perform physical exercise regularly; increase the intake of dietary food groups such as green leafy vegetables, fruits, and fatty fish; and recommendations for supplementation with antioxidants according an established formula.

干预措施: Standard lifestyle recommendations + dietary supplementation (Combination Product)

Standard recommendations + Risk profiling

Active Comparator

The second group (n=50) receives standard care plus personalized risk profiling. A risk scoring based on currently available literature for lifestyle and genetic risk will be used to determine personalized risks of conversion to late AMD. Individuals will be informed about their own risk profile and a personalized strategy will be communicated.

干预措施: Standard lifestyle recommendations + dietary supplementation (Combination Product)

结局指标

主要结局

Change in lifestyle score

时间窗: 12 and 24 months: follow-up phase

Change in lifestyle as measured by online questionnaires, scale from 0-13 in which 13 represents a healthy lifestyle

次要结局

未报告次要终点

研究者

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

Caroline C.W. Klaver, MD

Prof. dr. C.C.W. Klaver

Erasmus Medical Center

研究点 (1)

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