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临床试验/NCT05407896
NCT05407896Unknown不适用

End-Stage Kidney Disease Interactive Decision Aid for the Elderly (myKIDNEY)

Duke-NUS Graduate Medical School2 个研究点 分布在 1 个国家目标入组 208 人开始时间: 2021年7月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
208
试验地点
2
主要终点
Decisional conflict scale (0 to 100; higher scores indicate higher decisional conflict)

研究概览

简要总结

Decision aids are highly recommended for decisions when there is no "right" treatment choice. The goal is to help patients choose a treatment that is consistent with their preferences and to minimize decisional conflict and regret. A case where there is no "right" treatment concerns the decision to undergo dialysis or supportive care (i.e., conservative management) for elderly (aged ≥70) patients with end-stage kidney disease. The investigators propose to develop an interactive web-based decision aid and test its effectiveness via a pre-post study design. This research aims to reduce decisional conflict for elderly ESKD patients and caregivers.

详细描述

For patients aged 75 and above with comorbidities, the benefits of dialysis over kidney supportive care, which focuses on maintaining quality of life as opposed to life extension, are not clear. As there is no clear or "right" treatment choice, treatment decisions should be informed by patient preferences. However, currently in Singapore most patients choose dialysis and express decisional conflict and regret. Decision aids (DAs) together with values clarification methods (VCMs) can help patients choose a treatment that is concordant with their preferences and treatment goals. To help minimize decisional conflict among elderly ESKD patients, the first aim of this proposal is to adapt the current materials the investigators have developed (booklet and video) for elderly ESKD patients in a prior effort (NMRC/HSRG/0080/2017) into an interactive web-based tool called myKIDNEY. It will provide patients with tailored and relevant information based on their age and medical history, and help them identify and express their preferences via an interactive VCM. The second aim of the proposal is to test the benefits of counselling with myKIDNEY to standard renal counselling via a pre-post study design. The primary hypothesis is that patients and caregivers who receive counselling with myKIDNEY will report less decisional conflict compared to those who receive standard counselling. The investigators also hypothesize that fewer patients in the intervention arm will opt for dialysis, which is the more costly and invasive treatment option. If the proposed study shows evidence that the interactive tool improves decision-making quality in the local setting, this will result in a better patient experience. If fewer patients choose dialysis as per our hypothesis, this will also generate cost savings for the health system while at the same time allowing patients to choose their preferred treatment with lower chances of decisional conflict.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
主要目的
Health Services Research
盲法
Single (Participant)

入排标准

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

入选标准

  • (patients):
  • Incident CKD Stage 5 patients with GFR<15ml/min
  • Aged 70 years or older-
  • Have not undergone counselling with a renal counsellor
  • Cognitively intact as determined by the Abbreviated Mental Test (AMT)
  • Speak and read English or Mandarin
  • Inclusion Criteria (caregivers):
  • Primary informal caregiver for an eligible patient (primarily involved in providing care, ensuring provision of care, and/or in making decisions regarding patient's care)
  • Aged 21 years and older
  • Direct relative of the patient

排除标准

  • Patients deemed to be mentally incompetent, and those not aware of their diagnosis will be excluded.

结局指标

主要结局

Decisional conflict scale (0 to 100; higher scores indicate higher decisional conflict)

时间窗: 1 hour

Difference in decisional conflict scale between the intervention and comparison arms

次要结局

  • Stated preferred treatment(Assessed after renal counselling (within 2 weeks after renal counselling))
  • Actual treatment choice(12 months after renal counselling)

研究者

发起方
Duke-NUS Graduate Medical School
申办方类型
Other
责任方
Principal Investigator
主要研究者

Semra Ozdemir

Assistant Professor

Duke-NUS Graduate Medical School

研究点 (2)

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