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临床试验/NCT07243717
NCT07243717招募中不适用

The Effectiveness of an Information-Assisted Intervention for Potential Living Kidney Donors

National Taipei University of Nursing and Health Sciences2 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2026年3月27日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
45
试验地点
2
主要终点
Decision Self-Efficacy Scale

研究概览

简要总结

This study aims to evaluate the effectiveness of an information-assisted intervention in enhancing knowledge, decision self-efficacy, and reducing decisional conflict among potential living kidney donors. Using a one-group pretest-posttest design, participants will be recruited from the urology and kidney transplant outpatient clinics of two hospitals in northern Taiwan. After providing informed consent and completing a baseline questionnaire (T0), participants will receive a four-week information-assisted intervention in addition to routine care, with follow-up assessments at 4 weeks (T1) and 8 weeks (T2). Data will be collected using structured questionnaires assessing decisional conflict, decision self-efficacy, knowledge, positive thinking, family resilience, and satisfaction with the intervention.

详细描述

The purpose of this study is to examine the effectiveness of an information-assisted intervention in improving knowledge, decision self-efficacy, and decisional conflict among potential living kidney donors.

A one-group pretest-posttest design will be adopted. During the study period, participants will be recruited through convenience sampling from the urology and kidney transplant outpatient clinics of two hospitals in northern Taiwan. Eligible potential donors who have completed medical examinations and return for follow-up visits to review tissue matching and laboratory test results will be invited to participate in the study (experimental group). After providing informed consent, participants will complete a baseline questionnaire (T0) in a private setting.

Participants will then receive the information-assisted intervention, followed by the first posttest (T1) at 4 weeks and the second posttest (T2) at 8 weeks after T0. In addition to routine care, the experimental group will receive a four-week information-assisted intervention.

Data will be collected using structured questionnaires, including the Decisional Conflict Scale, Decision Self-Efficacy Scale, Knowledge Test on Living Kidney Donation, Demographic and Clinical Characteristics Questionnaire, Positive Thinking Scale, Evaluation Form for the Information-Assisted Program, and the Family Resilience Scale.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
20 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Willing to undergo evaluation for living kidney donation
  • Owns a smartphone or tablet with internet access
  • Able and willing to participate in the study and provide written informed consent

排除标准

  • - Deemed unsuitable for kidney donation after evaluation by a transplant specialist

研究组 & 干预措施

Information-Assisted group

Experimental

干预措施: Information-Assisted Intervention (Other)

结局指标

主要结局

Decision Self-Efficacy Scale

时间窗: Baseline (T0, prior to intervention), 4 weeks (T1) and 8 weeks (T2) after Baseline

The Chinese version of the Decision Self-Efficacy Scale from the Ottawa Hospital Research Institute will be used. This 11-item scale measures individuals' confidence in making informed decisions. Each item is scored from 0-4, with total scores converted to a range of 0-100. Higher scores reflect stronger decision self-efficacy.

Decisional Conflict Scale

时间窗: Baseline (T0, prior to intervention), 4 weeks (T1) and 8 weeks (T2) after Baseline

The study will employ the Chinese version of the Decisional Conflict Scale developed by the Ottawa Hospital Research Institute. The 16-item scale uses a 0-4 rating system (0 = yes, 4 = no). Total scores are calculated as (sum of items ÷ number of items) × 25, yielding a range of 0-100. Higher scores indicate greater decisional conflict.

Knowledge Test on Living Kidney Donation

时间窗: Baseline (T0, prior to intervention), 4 weeks (T1) and 8 weeks (T2) after Baseline

A 31-item self-developed test will assess participants' knowledge regarding living kidney donation, including anatomy, legal regulations, donor eligibility, medical coverage, surgical risks, postoperative complications, and post-surgical care. Each question has three options: True, False, and Unclear. Correct answers receive 1 point, while incorrect or unclear answers receive 0 points. Higher total scores indicate better knowledge.

次要结局

  • Positive Thinking Scale(Baseline (T0, prior to intervention), 4 weeks (T1) and 8 weeks (T2) after Baseline)

研究者

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

Ching-Hui Chien

RN, PhD, Professor

National Taipei University of Nursing and Health Sciences

研究点 (2)

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