Digital Patient Journey Solution for Patients Undergoing Elective Hip and Knee Arthroplasty Due to Primary Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 69
- 试验地点
- 2
- 主要终点
- Change in Health-related quality of life measured with EuroQol EQ-5D-5L
研究概览
简要总结
This is an interventional study which aims at assessing the effects of a digital patient journey solution in patients undergoing elective hip and knee arthroplasty due to primary osteoarthritis.
详细描述
Traditionally, pre- and postoperative education has been provided face-to-face by paper-based methods for patients undergoing total hip arthroplasty (THA) and total knee arthroplasty (TKA). Digital patient journey solution has potential to enhance adherence to preoperative preparation and postoperative rehabilitation, and further improve patient experience, while reducing potential adverse events.
The purpose of this study is to assess a digital patient journey solution developed for patients undergoing elective hip and knee arthroplasty. The digital solution aims to support patient's preparation to and recovery from a hip and knee arthroplasty through provision of timely information and support related to preoperative preparation and postoperative rehabilitation. The information on the application is aligned with the patient's individual needs and requirements, and contains exercises to be completed daily for the duration of the program.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
盲法说明
The group allocation is masked for the surgeon and for the outcome assessors
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years or older
- •Undergoing primary elective total hip or knee arthroplasty
- •Diagnosis of primary osteoarthritis of hip or knee (M16.0, M16.1, M17.0, M17.1)
- •Ability to speak, read and understand Finnish
- •Access to a web-based device
排除标准
- •Undergoing a total hip or knee arthroplasty revision
- •A bilateral total hip or knee arthroplasty
- •Total hip or knee arthroplasty following a rheumatoid arthritis
- •Inability to walk with use of walking aids
- •Unable to see or hear that impede the use of the digital patient journey solution
结局指标
主要结局
Change in Health-related quality of life measured with EuroQol EQ-5D-5L
时间窗: Change from baseline up to 6-8 weeks after TKA or at 8-12 weeks after THA
EuroQol EQ-5D-5L is a 5-level 5-dimensional standardized assessment tool. The index score (range 0-1 with 1 indicating perfect health and 0 indicating death) is used in the analyses.
次要结局
- Application user experience(6-8 weeks after TKA or at 8-12 weeks after THA)
- Patient experience post intervention(6-8 weeks after TKA or at 8-12 weeks after THA)
- Postoperative adherence(From discharge (1-3 days after the surgery) until 6-8 weeks after TKA or at 8-12 weeks after THA for the intervention group only)
- Change in the Western Ontario and McMaster Osteoarthritis Index (WOMAC)(Change from baseline up to 6-8 weeks after TKA or at 8-12 weeks after THA)
- Self-efficacy regarding postoperative preparation(At discharge (1-3 days after the surgery))
- Change in Oxford Hip Score (OHS)(60 days prior surgery and 120 days after the surgery)
- Preoperative adherence(From baseline until the date of the surgery for the intervention group only)
- Patient experience post surgery(At discharge (1-3 days after the surgery))
- Technological self-efficacy(At baseline, and 6-8 weeks after TKA or at 8-12 weeks after THA)
- Self-efficacy regarding preoperative preparation(At baseline)
- Self-efficacy during postoperative rehabilitation(At 1, 3, and 5 weeks after THA/TKA for the intervention group only)
- Change Oxford Knee Score (OKS)(60 days prior surgery and 120 days after the surgery)