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临床试验/NCT05940246
NCT05940246已完成不适用

The Empowerment Study

Region Stockholm2 个研究点 分布在 1 个国家目标入组 149 人开始时间: 2022年4月28日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
149
试验地点
2
主要终点
Satisfaction with the knee

研究概览

简要总结

Knee arthroplasty is a successful surgical treatment for end-stage osteoarthritis. Most patients are satisfied with the result, however, 10% of the patients have remained dissatisfied over the last decades despite the advantages of the surgical procedure. Previous studies suggest that rehabilitation needs to be individualized and that some patients request additional support.

Patient empowerment is a patient-centered strategy to increase, amongst other, patient engagement, participation, and motivation. Patient empowerment can be defined as a "process that helps people gain control over their own lives and increases their capacity to act on issues that they themselves define as important". One way of increasing patient empowerment is through motivational interviewing. Motivational interviewing is an evidence-based approach in which patients are supported to identify behavior changes toward their own individual goals.

The aim of this study is to investigate if motivational interviewing could increase satisfaction in patients undergoing knee arthroplasty. Furthermore, we want to examine role MI in this patient group with interviews of both MI-practitioners and patients as well as detailed investigations about the MI sessions.

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

性别
All
接受健康志愿者

入选标准

  • Scheduled for primary knee arthroplasty

排除标准

  • 未提供

研究组 & 干预措施

Motivational interviewing

Experimental

Motivational Interviewing over the phone 1 time before surgery and 6 times (3-5 weeks interval) the first 6 months after surgery. Patients can contact a physical therapist in the first 6 months after surgery for additional questions and extra support.

干预措施: Motivational Interviewing (Behavioral)

Standard treatment

No Intervention

Standard treatment

结局指标

主要结局

Satisfaction with the knee

时间窗: Assessed 12 months postoperatively

Patient reported outcome. Question: "How would you define your level of satisfaction with your operated knee?" Answer options: (1) Very satisfied, (2) Satisfied, (3) Neither, (4) Dissatisfied and (5) Very dissatisfied

Satisfaction with the rehabilitation

时间窗: Assessed 12 months postoperatively

Patient reported outcome. Question: "How would you define your level of satisfaction with the rehabilitation?" Answer options: (1) Very satisfied, (2) Satisfied, (3) Neither, (4) Dissatisfied and (5) Very dissatisfied

Satisfaction with the rehabilitation

时间窗: Assessed 6 months postoperatively

Patient reported outcome. Question: "How would you define your level of satisfaction with the rehabilitation?" Answer options: (1) Very satisfied, (2) Satisfied, (3) Neither, (4) Dissatisfied and (5) Very dissatisfied

Satisfaction with the knee

时间窗: Assessed 6 months postoperatively

Patient reported outcome. Question: "How would you define your level of satisfaction with your operated knee?" Answer options: (1) Very satisfied, (2) Satisfied, (3) Neither, (4) Dissatisfied and (5) Very dissatisfied

次要结局

  • Knee awareness(Preoperatively, 6 months postoperatively and 12 months postoperatively)
  • Self-reported pain and function(Preoperatively, 6 months postoperatively and 12 months postoperatively)
  • Patient reported experience measures(12 months postoperatively)
  • Knee function(Preoperatively, 6 months postoperatively and 12 months postoperatively)
  • Knee improvement(6 months postoperatively, 12 months postoperatively)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

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