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RECOVER-E - 一款为全膝关节或髋关节置换术后患者设计的移动应用程序:研究方案。

RECOVER-E - a mobile app for patients undergoing total knee or hip replacement: study protocol.

机构信息

Institute of Nursing Science and Practice, Paracelsus Medical University, Strubergasse 21, 5020, Salzburg, Austria.

Faculty of Health Sciences, Bielefeld University, Universitätsstraße 25, 33615, Bielefeld, Germany.

出版信息

BMC Musculoskelet Disord. 2020 Feb 4;21(1):71. doi: 10.1186/s12891-020-3090-2.

Abstract

BACKGROUND

Total knee replacement (TKR) or total hip replacement (THR) are common and effective procedures in patients with osteoarthritis (OA) to restore physical function and reduce joint related pain. Patient education plays an important role in the treatment process aiming to develop necessary self-management skills to facilitate recovery and ensure long-term success. We have developed a mobile app (RECOVER-E) for iOS and Android smartphones which provides important information on the preoperative phase, surgery and recovery. The concomitant study will determine the efficacy of RECOVER-E on patients' surgical outcomes.

METHODS/DESIGN: This study is a non-randomized, multi-centre (4 sites), double-arm, controlled trial with 1:1 assignment. 160 patients undergoing primary TKR or THR will be recruited from January until October 2019 in 4 German hospitals. Both groups will receive standard care. Additionally, the intervention group will use the app RECOVER-E. Measurements will be taken 4-6 weeks before surgery, on the day of admission to the hospital, on the first and 7th postoperative day and 3 months post-surgery. Primary outcome will be self-reported physical function measured on the activities of daily living (ADL) subscale of the Knee injury and Osteoarthritis Outcome Score (KOOS) and the Hip disability and Osteoarthritis Outcome Score (HOOS) for patients with knee and hip osteoarthritis, respectively. Secondary outcomes include the subscales for pain, symptoms, function in sport and recreation and knee/hip-related quality of life of the HOOS and KOOS, preoperative anxiety, measured by the Hospital Anxiety and Depression Scale (HADS), as well as, pain at rest and pain during activity measured by a numerical rating scale (NRS). Primary endpoint is 3 months post-surgery.

DISCUSSION

Mobile Health (mHealth) has become increasingly important in patient-centred health care aiming to enhance patient involvement and self-management capabilities. To our knowledge this is the first study to investigate the effect of an evidence-based mobile app on patient reported outcomes after joint replacement. This study should provide evidence supporting the use of mHealth to facilitate recovery and open up new possibilities for patient care in joint replacement.

TRIAL REGISTRATION

DRKS Data Management retrospectively registered.

DRKS-ID: DRKS00012744.

摘要

背景

全膝关节置换术(TKR)或全髋关节置换术(THR)是治疗骨关节炎(OA)患者恢复身体功能和减轻关节相关疼痛的常用且有效的方法。患者教育在治疗过程中起着重要作用,旨在培养必要的自我管理技能,以促进康复并确保长期成功。我们已经为 iOS 和 Android 智能手机开发了一款名为 RECOVER-E 的移动应用程序,该应用程序提供了有关术前阶段、手术和康复的重要信息。伴随研究将确定 RECOVER-E 对患者手术结果的疗效。

方法/设计:这是一项非随机、多中心(4 个地点)、双臂、对照试验,采用 1:1 分配。2019 年 1 月至 10 月,将在德国的 4 家医院招募 160 名接受初次 TKR 或 THR 的患者。两组均接受标准护理。此外,干预组将使用 RECOVER-E 应用程序。测量将在手术前 4-6 周、住院当天、术后第 1 天和第 7 天以及术后 3 个月进行。主要结局是膝关节骨关节炎和髋关节骨关节炎患者的日常生活活动(ADL)子量表的膝关节损伤和骨关节炎结果评分(KOOS)以及髋关节残疾和骨关节炎结果评分(HOOS)的自我报告身体功能。次要结局包括 HOOS 和 KOOS 的疼痛、症状、运动和娱乐功能以及膝关节/髋关节相关生活质量的子量表、术前焦虑,用医院焦虑和抑郁量表(HADS)测量,以及静息时疼痛和活动时疼痛,用数字评分量表(NRS)测量。主要终点是术后 3 个月。

讨论

移动医疗(mHealth)在以患者为中心的医疗保健中变得越来越重要,旨在增强患者的参与度和自我管理能力。据我们所知,这是第一项研究使用基于证据的移动应用程序对关节置换术后患者报告的结果进行研究的研究。这项研究应该为使用 mHealth 促进康复提供证据,并为关节置换患者护理开辟新的可能性。

试验注册

DRKS 数据管理公司进行了回顾性注册。

DRKS-ID:DRKS00012744。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/43ca/7001367/1c648545e512/12891_2020_3090_Fig1_HTML.jpg

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