The Use of the GRASP System for Postoperative Monitoring - a Feasibility Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Feasibility of the intervention study
研究概览
简要总结
The aim of this study is to explore feasibility and user experience of a novel digital system containing a handheld electronic device and a mobile application - called Grasp - in the setting of postoperative monitoring of pain and patient reported outcome measures in knee arthroplasty patients.
The investigators will use a mixed-methods approach to gain in-depth insights into feasibility and user experience of this system in order to evaluate further improvement needs of both study design and intervention before a final randomised effect study. Feasibility will be evalutated through recruittment rates, adhererance to intervention protocol and study data sampling, and completion rates. Fidelity will be assessed as number of patients who are able to do as instructed in the protocol. In addition, the investigators will explore user experience through questionnaires after 2 and 6 weeks of use and through semi-structered interviews of participants and associated physiotherapists. Interviews will be transcribed for qualitative analyses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective joint arthroplasty
- •Age: 30-70 years
- •Must own and be able to use a smart phone
- •Speak and understand Norwegian
排除标准
- •Not able to give informed consent
研究组 & 干预措施
Grasp system
Grasp system (hardware and mobile application) during first 6 postsurgical weeks of rehabilitation. Subjects are instructed to report pain through squeezing the hardware in 3 different levels regulaly during the day, and, in addition enter answers to questions on patient reported outcome meassures (sleep quality, overall well-being, use of medication, appetit, physical activity) and register exercise time into the mobile application. Data entries will be presented as trajectories in graphs and charts in the app. At their 6 weeks physiotherapist consult, the physiotherapists will use the data during the consult.
干预措施: Grasp (Device)
结局指标
主要结局
Feasibility of the intervention study
时间窗: From enrollment to 6 weeks after surgery
Feasibility of the intervention study will be evalutated through adhererance to intervention protocol. It will be assessed as number of patients who are able to do as instructed in the protocol. Fidilty \>80% will be considered high, 50-80% moderate, and \<50% low. The investigators expect a priori the adherance to protocol guidelines to decline during the 6 weeks intervention period
User experience
时间窗: From enrollment to 6 weeks post surgery
Mixed methods approach will be used to evaluate user experience. The investigators will make a mixed methods synthsis between participants questionnaires (by 2 and 6 weeks of intervention) and semi-structured interviews of up to 10 participants and associated physiotherapists by the end of the intervention period.
次要结局
未报告次要终点