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临床试验/NCT04761757
NCT04761757已完成不适用

Antidepressant Decision Aid for Major Depressive Disorder Patients

University of Malaya17 个研究点 分布在 1 个国家目标入组 752 人开始时间: 2019年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
752
试验地点
17
主要终点
Preparation for Decision Making_Physician Perspective

研究概览

简要总结

The purpose of this study is to determine whether Antidepressant Decision Aid for Major Depressive Disorder is feasible and effective in involving patients in the decision-making process when initiating pharmacotherapy.

详细描述

To examine the ability of the patient decision aid to enhance shared decision making and preparedness to make decisions pertaining to antidepressant therapy. The research team has systematically developed an Antidepressant Decision Aid for Major depressive disorder patients (ADAM) according to the International Patient Decision Aids Standards (IPDAS) and the Ottawa Decision Support Framework. This is a posttest-only study with nonequivalent groups to evaluate the effect of the antidepressant decision aid on patient and physician perception of shared decision making as well as patient preparedness for making pharmacotherapeutic decisions compared usual care.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Health Services Research
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

  • Diagnosed with Major Depressive Disorder (MDD)
  • No psychotic symptoms
  • Based on psychiatrist's clinical judgement currently in need for antidepressant treatment.
  • Functional English literacy and language skills (to use the decision aid and fill out the questionnaires)
  • Provides consent

排除标准

  • Psychosis
  • Communication barriers (visual impairment, language barrier)

结局指标

主要结局

Preparation for Decision Making_Physician Perspective

时间窗: Immediately after the clinical encounter

The physician version of the Preparation for Decision-Making Scale (PDMS) assesses the physician's perception of how the PDA helped patients recognize that a decision needs to be made, preparing them to communicate with their practitioner and promote patient involvement in the decision-making process. Higher scores indicate a higher perceived level of preparation for decision making.

Shared Decision Making_Patient Perspective

时间窗: Immediately after the clinical encounter

The patient version of the Shared Decision Making scale (SDM-Q-9) measures the extent to which patients are involved in the decision-making process from the patient's perspective. It consists of nine items rated on a six-point Likert-type scale from"completely disagree=" to"completely agree=". Adding the score of all the items leads to a raw total between 0 and 45. Multiplying the raw score by 20/9 provides a transformed score ranging from 0 to 100, higher scores indicate a greater extent of SDM.

Shared Decision Making_Physician Perspective

时间窗: Immediately after the clinical encounter

The physician version of Shared Decision Making scale (SDM-Q-Doc) measures the extent to which patients are involved in the decision-making process from the physician's perspective. It consists of nine items rated on a six-point Likert-type scale from"completely disagree=" to"completely agree=". Adding the score of all the items leads to a raw total between 0 and 45. Multiplying the raw score by 20/9 provided a transformed score ranging from 0 to 100, higher scores indicate a greater extent of SDM.

Preparation for Decision Making_Patient Perspective

时间窗: Immediately after the clinical encounter

The patient version of the Preparation for Decision-Making Scale (PDMS) assesses the patient's perception of how the PDA helped them recognize that a decision needs to be made, preparing them to communicate with their practitioner and promote patient involvement in the decision-making process. Higher scores indicate a 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 (17)

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