传感器监测在髋部骨折老年患者职业治疗康复计划中的有效性：SO-HIP试验——一项三臂阶梯楔形整群随机试验的研究方案
Effectiveness of sensor monitoring in an occupational therapy rehabilitation program for older individuals after hip fracture, the SO-HIP trial: study protocol of a three-arm stepped wedge cluster randomized trial.
作者信息
Pol Margriet C, Ter Riet Gerben, van Hartingsveldt Margo, Kröse Ben, de Rooij Sophia E, Buurman Bianca M
机构信息
Research Group Occupational Therapy, ACHIEVE, Centre of Applied Research, Faculty of Health, Amsterdam University of Applied Sciences, Room B 122, Tafelbergweg 51, PO Box 2557, 1000CN, Amsterdam, The Netherlands.
Department General Practice, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.
出版信息
BMC Health Serv Res. 2017 Jan 3;17(1):3. doi: 10.1186/s12913-016-1934-0.
BACKGROUND
The performance of activities of daily living (ADL) at home is important for the recovery of older individuals after hip fracture. However, 20-90% of these individuals lose ADL function and never fully recover. It is currently unknown to what extent occupational therapy (OT) with coaching based on cognitive behavioral treatment (CBT) improves recovery. The same holds for sensor monitoring-based coaching in addition to OT. Here, we describe the design of a study investigating the effect of sensor monitoring embedded in an OT rehabilitation program on the recovery of ADL among older individuals after hip fracture.
METHODS/ DESIGN: Six nursing homes will be randomized in a three-arm stepped wedge cluster randomized trial. All nursing homes will initially provide standard care. At designated time points, nursing homes, successively and in random order, will cross over to the provision of OT and at the next time point, to sensor monitoring-enhanced OT. A total of 288 older individuals, previously living alone in the community, who after a hip fracture were admitted to a geriatric rehabilitation ward for a short-term rehabilitation, will be enrolled. Individuals in the first intervention group (OTc) will participate in an OT rehabilitation program with coaching based on cognitive behavioral therapy (CBT) principles. In the sensor monitoring group, sensor monitoring is added to the OT intervention (OTcsm). Participants will receive a sensor monitoring system consisting of (i) an activity monitor during nursing home stay, (ii) a sensor monitoring system at home and a (iii) a web-based feedback application. These components will be embedded in the OT. The OT consists of a weekly session with an occupational therapist during the nursing home stay followed by four home visits and four telephone consultations. The primary outcome is patient-perceived daily functioning at 6 months, assessed using the Canadian Occupational Performance Measure (COPM).
DISCUSSION
As far as we know, this study is the first large-scale stepped wedge trial, studying the effect of sensor monitoring embedded in an OT coaching program. The study will provide new knowledge on the combined intervention of sensor monitoring and coaching in OT as a part of a rehabilitation program to enable older individuals to perform everyday activities and to remain living independently after hip fracture.
TRIAL REGISTRATION NUMBER
Netherlands National Trial Register, NTR 5716 Date registered: April 1 2016.
背景
在家中进行日常生活活动（ADL）的能力对于髋部骨折老年患者的康复至关重要。然而，这些患者中有20% - 90%会丧失ADL功能且无法完全恢复。目前尚不清楚基于认知行为疗法（CBT）指导的职业疗法（OT）在多大程度上能促进康复。同样，除OT外基于传感器监测的指导效果也不清楚。在此，我们描述一项研究的设计，该研究旨在调查OT康复计划中嵌入的传感器监测对髋部骨折老年患者ADL恢复的影响。
方法/设计：六家养老院将被随机分配到一个三臂阶梯楔形整群随机试验中。所有养老院最初都将提供标准护理。在指定时间点，各养老院将依次且随机地过渡到提供OT，在下一个时间点，过渡到传感器监测增强的OT。总共288名先前独自居住在社区的老年人将被纳入研究，这些老年人髋部骨折后被收治到老年康复病房进行短期康复。第一个干预组（OTc）的个体将参与基于认知行为疗法（CBT）原则指导的OT康复计划。在传感器监测组中，传感器监测被添加到OT干预中（OTcsm）。参与者将获得一个传感器监测系统，该系统包括：（i）在养老院期间的活动监测器，（ii）在家中的传感器监测系统，以及（iii）基于网络的反馈应用程序。这些组件将被嵌入到OT中。OT包括在养老院期间每周与职业治疗师进行一次会面，随后进行四次家访和四次电话咨询。主要结局是在6个月时患者自我感知的日常功能，使用加拿大职业表现测量量表（COPM）进行评估。
讨论
据我们所知，本研究是首个大规模阶梯楔形试验，研究OT指导计划中嵌入的传感器监测的效果。该研究将为传感器监测与OT指导相结合的干预措施提供新知识，作为康复计划的一部分，使老年患者能够进行日常活动并在髋部骨折后保持独立生活。
试验注册号
荷兰国家试验注册库，NTR 5716 注册日期：2016年4月1日。
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