Patient-centered and Economic Effectiveness of a Decision Aid for Patients With Age-related Cataract: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 773
- 试验地点
- 1
- 主要终点
- Informed choice about cataract surgery (the proportion of participants who make an informed choice，which is defined as a good knowledge score and an intention that is consistent with their attitude score)
研究概览
简要总结
To determine whether a decision aid increases informed decision about cataract surgery for patients with age-related cataract.
详细描述
The need for cataract surgery is on the rise globally due to the aging population and high demands for greater visual functioning. Patients with age-related cataract face their initial decision about when to undergo cataract surgery. Although the majority of patients want to participate in a shared decision-making process, no decision aid has been available to improve the quality of decision. The purpose of this study is to determine whether a decision aid increases informed decision about cataract surgery for patients with age-related cataract.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals aged 50-80 years who have been resident in the selected study district for more than six months;
- •A definite diagnosis of age-related cataract;
- •Having not received cataract surgery;
- •Willing to participate in the study and provide informed content.
排除标准
- •Bilateral blindness (presenting distance visual acuity worse than 3/60);
- •Having ocular, hearing or mental disorder precluding reading or telephone interview;
- •Ocular disorders other than cataract leading to permanent vision loss that could not be corrected through cataract surgery;
- •Having cataract surgery contraindication.
结局指标
主要结局
Informed choice about cataract surgery (the proportion of participants who make an informed choice，which is defined as a good knowledge score and an intention that is consistent with their attitude score)
时间窗: 2 weeks post intervention
Informed choice is an aggregated measure of multiple measurements, including knowledge (a 12-item questionnaire that assesses conceptual (items 1-10) and numerical (items 11-12) knowledge), attitudes (6 items, with 5 responses for each), and intentions (single item with 5 responses) Analysis: Informed Choice= Good Knowledge (score ≥50% in basic knowledge, ≥40% in knowledge associated with each treatment option, and at least 1 point in each numerical knowledge question) AND Positive Attitude (score ≥24) AND Positive Intention ("definitely will" or "likely to"), OR Good Knowledge AND Negative Attitude (score \<23) AND Negative Intention ("unsure", "not likely to", or "definitely will not")
次要结局
- Decisional confidence(2 weeks post intervention)
- Anticipated regret(2 weeks post intervention)
- Perceived importance of surgical benefit/harms(2 weeks post intervention)
- Perceived personal chances of surgical benefit/harms(2 weeks post intervention)
- Decisional conflict(2 weeks post intervention)
- Time perspective(2 weeks post intervention)
- Heath-related quality of life: Chinese version of the EQ-5D-5L telephone interview script(Baseline, 1 year post intervention)
- Costs(Baseline, 1 year post intervention)
- Cataract worry and anxiety(2 weeks post intervention)
- Booklet utilization and acceptability(2 weeks post intervention)
- Undergoing cataract surgery(1 year post intervention)
- Decision regret(1 year post intervention)
- Visual functioning(Baseline, 1 year post intervention)
- Fall questionnaire(1 year post intervention)
研究者
Yingfeng Zheng
Principal Investigator
Sun Yat-sen University