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临床试验/NCT06008171
NCT06008171进行中(未招募)不适用

Patient Decision Aid for the Treatment of Actinic Keratosis

Maastricht University Medical Center1 个研究点 分布在 1 个国家目标入组 106 人开始时间: 2022年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
106
试验地点
1
主要终点
Difference in shared decision making

研究概览

简要总结

This study evaluates whether a Patient Decision Aid for the field-directed treatment of actinic keratosis has an effect on shared decision making and patient satisfaction.

详细描述

Actinic keratosis is the most common epithelial precancerous lesion among the Caucasian race. With an increase in prevalence worldwide due to an aging population and rise of ultraviolet exposure actinic keratosis are among the most frequently encountered skin lesions in clinical practice.

There are many therapeutic modalities for the treatment of actinic keratosis, depending on multiple factors such as distribution, characteristics, patient preference, side effects, availability and costs. Treatment options can be divided into: lesion directed therapy en field directed therapy.

A Patient Decision Aid for field-directed therapies for actinic keratosis may attribute to better shared-decision making and patient satisfaction which on their part may benefits treatment compliance and health outcomes and may lead to fewer disputes between patients and doctors.

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
None

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

  • diagnosis actinic keratosis in MaastrichtUMC+ or CatharinaHospital, Eindhoven
  • age >18 years

排除标准

  • no knowledge of Dutch language

结局指标

主要结局

Difference in shared decision making

时间窗: First questionnaire at moment of consultation, between November 2022 and January 2024 (expected). Second questionnaire after finishing the treatment (1 week after consultation up to 6 months after consultation).

Difference in shared decision making in the group with Patient Decision Aid and the group without Patient Decision Aid, measured with Shared Decision Making-Q-9 questionnaire Dutch version. This scale uses 9 questions with a maximum score of 45. 0 indicating the lowest and 45 indicating the highest level of perceived shared decision making.

Difference in patient satisfaction

时间窗: First questionnaire at moment of consultation, between November 2022 and January 2024 (expected). Second questionnaire after finishing the treatment (1 week after consultation up to 6 months after consultation).

Difference in patient satisfaction making in the group with Patient Decision Aid and the group without Patient Decision Aid, measured with Decision Evaluation Scales. This scale uses 15 questions with a maximum score of 75. Higher scores mean more satisfaction and less insecurity.

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 (1)

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