NCT03240913已完成不适用
A PROMs Based Educational Tool (PROM-DA) for Patients Considering Total Knee Arthroplasty: Development and a Pilot Randomized Controlled Trial.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 163
- 试验地点
- 2
- 主要终点
- Decision quality
研究概览
简要总结
The primary objectives of this study are to: 1) develop an educational tool known as the Patient Reported Outcome Measure informed Decision Aid (PROM-DA) that will describe the options for patients considering total knee arthroplasty (TKA) surgery, and help them imagine what to expect if they choose either option; 2) assess the extent that the PROM-DA improves patients decision quality; 3) determine the feasibility of a larger trial to test the PROM-DA in multiple sites and more patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult (age≥30) patients with knee osteoarthritis (OA)
- •Have an appointment with a surgeon for consultation about Total Knee Arthroplasty at the Edmonton Bone and Joint Centre
- •Understands, speaks and reads English; and
- •Able to provide informed consent.
排除标准
- •Individuals who have had prior total knee arthroplasty
- •Physician-diagnosed Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Fibromyalgia, or Gout.
结局指标
主要结局
Decision quality
时间窗: 40 to 52 weeks after baseline
Hip and Knee Decision Quality Instrument (HK-DQI)
次要结局
- Depression(40 to 52 weeks after baseline)
- Decisional regret(40 to 52 weeks after baseline)
- Concordance(40 to 52 weeks after baseline)
- Quality of life (condition-specific)(40 to 52 weeks after baseline)
- Quality of life (generic)(40 to 52 weeks after baseline)
- Values(Baseline)
- Knowledge about total knee arthroplasty surgery(Baseline)
- Willingness to have surgery(Baseline)
- Expectations(40 to 52 weeks after baseline)
- Surgical consult(1 to 4 weeks after baseline)
- Surgery(27 to 30 weeks after baseline)
- Decisional conflict(Baseline)
- Preference for involvement in decision making(Baseline)
- Satisfaction with knee replacement surgery(40 to 52 weeks after baseline)
- Treatment Preference(Baseline)
- Patient-reported shared decision-making(3 to 6 weeks after baseline)
研究者
研究点 (2)
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