跳至主要内容
临床试验/NCT05666544
NCT05666544招募中不适用

Developing and Effectiveness Evaluation of Web-based Situation Renal Replacement Therapies Patient Decision Aids

China Medical University Hospital2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2022年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
70
试验地点
2
主要终点
Changes to the Decisional Conflict Scale (DCS)

研究概览

简要总结

Different renal replacement therapy methods will cause significant impacts on the physical, mental, and social for patients with end-stage renal disease. Application shared decision-making should be able to effectively assist patients in choosing suitable renal replacement therapy. Currently, most of the patient decision aid of renal replacement therapy are written health education leaflets, which have problems such as too many words, more difficult content, and inconvenience. In shared decision-making, even though different treatment options are communicated to patients, there is still a gap between "understanding" and "real experience", it will be creating uncertainty of decision, and emphasizing true situational learning strategies should be a viable auxiliary method. Therefore, this study aims to develop a web-based patient decision aid of renal replacement therapy and integrates situational learning strategies into it. First, investigators have conducted a qualitative study to explore the related experience of patients with end-stage renal disease the decision-making needs in renal replacement therapy choice, and the experience and barrier of reading paper patient decision aid. Next, based on the results of the pilot study, the modified Delphi method will be used to collect the opinions of experts, and the situational learning theory will be integrated into the patient decision aid to develop the web-based situation renal replacement therapies patient decision aid. After completion, investigators will apply quasi-experimental, a repeated measurement that will be adopted to analyze the effectiveness of web-based patient decision aid of renal replacement therapy in shared decision-making in patients with end-stage renal disease.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Outcomes Assessor)

入排标准

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

入选标准

  • Diagnosed by nephrologists as patients with chronic kidney disease, and GFR <30 ml/min/1.73m
  • As a patient admitted to the "Pre-ESRD care plan".
  • Clear awareness, ability to communicate in Mandarin and Taiwanese, and agree to participate in the research.
  • Those who are unable to answer the questions without other serious diseases or diseases affecting the mind.

排除标准

  • Those who cannot freely choose hemodialysis or peritoneal dialysis due to absolute contraindications.

结局指标

主要结局

Changes to the Decisional Conflict Scale (DCS)

时间窗: Baseline, immediately post-intervention, and one-month post-intervention.

The DCS is a self-reported instrument assessing individual conflict and uncertainty about decision-making. Possible scores range from 0 (strongly agree) to 4 (strongly disagree). The higher the score, the higher the decisional conflict.

Decision Regret Scale (DRS)

时间窗: One-month post-intervention.

The DRS is a self-reported instrument measuring regret about health-related decisions. Possible scores range from 1 (strongly agree) to 5 (strongly disagree). Higher scores indicate higher decision-making regret.

Changes to the Preparation for Decision Making Scale (PrepDMS)

时间窗: Baseline and immediately post-intervention.

The PrepDMS is a self-reported instrument assessing perceptions of usefulness in communicating health decisions. Possible scores range from 1(not at all) to 5 (a great deal). The higher the score, the higher the readiness for decision-making.

Changes to the Renal Replacement Therapy Knowledge Scale (RRTKS)

时间窗: Baseline and immediately post-intervention

The RRTKS is a self-reported instrument to assess knowledge of different treatment modalities. Scored as correct (1 point) and incorrect (0 points). Higher scores indicate higher knowledge of different treatment modalities.

Changes to the Decision Self Efficacy Scale (DSES)

时间窗: Baseline, immediately post-intervention, and one-month post-intervention.

The DSES is a self-reported instrument assessing an individual's confidence or belief in their ability to make decisions. Possible scores range from 0 (not at all conflict) to 4 (very conflict). The higher the score, the higher the decision-making self-efficacy.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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