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临床试验/NCT02488317
NCT02488317已完成不适用

Empowering Patients On Choices for Renal Replacement Therapy (Aim 3)

Arbor Research Collaborative for Health2 个研究点 分布在 1 个国家目标入组 234 人开始时间: 2015年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
234
试验地点
2
主要终点
Decisional Conflict

研究概览

简要总结

Empowering Patients On Choices for Renal Replacement Therapy (EPOCH-RRT) study seeks to identify factors that matter the most to patients with kidney disease and study how they are impacted by different types of dialysis. The inclusion of patients, caregivers, and patient advocacy organizations as research partners will assure that the study addresses questions of greatest relevance to patients facing the need for dialysis.

For Aim 3, the investigators are going to compare measures related to the decision-making process between patients receiving and not receiving a decision aid focusing on Peritoneal Dialysis and Hemodialysis.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other

入排标准

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

入选标准

  • 18 years and older
  • Speaks English
  • Has access to the internet

排除标准

  • 未提供

结局指标

主要结局

Decisional Conflict

时间窗: 6 months

Measured using the scale from O'Connor, Annette M. "Validation of a Decisional Conflict Scale." Medical Decision Making 15, no. 1 (February 1, 1995): 25-30. 16 item scale, responses to each statement are scored from 1 (strongly agree) to 5 (strongly disagree), with negative statements having reverse scoring; thus high scores indicate higher decisional conflict. Mean score per participant is calculated across all items, subtract by 1 and multiplied by 25. Score range= 0-100. Mean scores across all participants in each arm are reported.

Preference for Shared Decision Making

时间窗: 6 months

Measured using the scale from Degner, L. F., Sloan, J. A., \& Venkatesh, P. (1996). The Control Preferences Scale. The Canadian journal of nursing research= Revue canadienne de recherche en sciences infirmieres, 29(3), 21-43. The CPS is a clinically relevant, easily administered, valid, and reliable measure of preferred roles in health-care decision-making. A pick-one approach was used to identify patient preference for an active, passive or collaborative role in dialysis treatment decision making.

Decision Self-efficacy

时间窗: 6 months

Measured through the scale found in Decision Self-Efficacy Ottawa: Ottawa Hospital Research Institute; © 1995 Available from: http://decisionaid.ohri.ca/docs/develop/User_Manuals/UM_Decision_SelfEfficacy.pdf O'Connor 1995 Items are scored 0(not at all confident) to 4 (very confident). Scores are summed across 10 items, divided by 10 and multiplied by 25. Scores range from 0-100. A score of 0 means "extremely low self efficacy" and a score of 100 means "extremely high self efficacy".

Knowledge

时间窗: 6 months

Measured using scale from Cavanaugh K"Patient Dialysis Knowledge Is Associated with Permanent Arteriovenous Access Use in Chronic Hemodialysis." Clinical Journal of the American Society of Nephrology 4, no. 5: 950-56) Multiple choice questions with one correct answer per questions. Number of correct questions reported as a percentage of total number of questions (23).

Preparation for Decision Making

时间窗: 6 months

Measured using Bennett, Carol, "Validation of a Preparation for Decision Making Scale." Patient Education and Counseling 78, no. 1: 130-33 10 item scale, each item scored from 1 (not at all) to 5 (a great deal). items are summed and scored, converted to a 0-100 scale by subtracting 1 from the summed score and multiplying by 25. Higher scores indicate higher perceived level of preparation for decision making.

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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