Bone & Joint Health, Blizard Institute, Queen Mary University of London, London, United Kingdom.
Department of Population Health Sciences, School of Life Course and Population Health, Faculty of Life Science and Medicine, King's College London, London, United Kingdom.
PLoS One. 2024 Aug 12;19(8):e0306871. doi: 10.1371/journal.pone.0306871. eCollection 2024.
A high proportion of patients do not regain outdoor mobility after hip fracture. Rehabilitation explicitly targeting outdoor mobility is needed to enable these older adults to recover activities which they value most. The overarching aim of this study is to determine the feasibility of a randomised controlled trial which aims to assess the clinical- and cost-effectiveness of an intervention designed to enable recovery of outdoor mobility among older adults after hip fracture (the OUTDOOR intervention).
This is a protocol for a multi-centre pragmatic parallel group (allocation ratio 1:1) randomised controlled assessor-blinded feasibility trial. Adults aged 60 years or more, admitted to hospital from- and planned discharge to- home, with self-reported outdoor mobility in the three-months pre-fracture, surgically treated for hip fracture, and who are able to consent and participate, are eligible. Individuals who require two or more people to support mobility on discharge will be excluded. Screening and consent (or consent to contact) will take place in hospital. Baseline assessment and randomisation will follow discharge from hospital. Participants will then receive usual care (delivered by physiotherapy, occupational therapy, or therapy assistants), or usual care plus the OUTDOOR intervention. The OUTDOOR intervention includes a goal-orientated outdoor mobility programme (supported by up to six in-person visits), therapist-led motivational dialogue (supported by up to four telephone calls), supported by a past-patient led video where recovery experiences are shared, and support to transition to independent ongoing recovery. Therapists delivering the OUTDOOR intervention (distinct from those supporting usual care) will receive training in motivational interviewing and behaviour change techniques. Baseline demographics will be collected. Patient reported outcome measures including health related quality of life, activities of daily living, pain, community mobility, falls related self-efficacy, resource use, readmissions, and mortality will be collected at baseline, 6-weeks, 12-weeks, and 6-months (for those enrolled early in the trial) post-randomisation. Exercise adherence (6- and 12- weeks) and intervention acceptability (12-weeks) will be collected. A subset of 20 participants will also support accelerometery data collection for 10 days at each time point.
The trial findings will be disseminated to patients and the public, health professionals and researchers through publications, presentations and social media channels.
The trial has been registered at ISRCTN16147125.
3.0.
相当大比例的髋部骨折患者无法恢复户外活动能力。需要明确针对户外活动能力的康复干预，以使这些老年人能够恢复他们最看重的活动。本研究的总体目标是确定一项随机对照试验的可行性，该试验旨在评估一项旨在使髋部骨折后老年人恢复户外活动能力的干预措施的临床和成本效益（OUTDOOR 干预）。
这是一项多中心实用平行组（分配比例 1:1）随机对照评估员盲法可行性试验的方案。60 岁或以上的成年人，在受伤后住院并计划从医院出院回家，在骨折前三个月有自我报告的户外活动能力，接受手术治疗髋部骨折，并且能够同意并参与，符合条件。出院时需要两人或以上协助移动的人将被排除在外。筛选和同意（或同意联系）将在医院进行。出院后将进行基线评估和随机分组。然后，参与者将接受常规护理（由物理治疗师、职业治疗师或治疗助理提供），或常规护理加 OUTDOOR 干预。OUTDOOR 干预包括以目标为导向的户外活动计划（最多支持 6 次面对面访问）、治疗师主导的动机对话（最多支持 4 次电话访问）、由过去的患者主导的视频支持，分享康复经验，以及过渡到独立持续康复的支持。提供 OUTDOOR 干预（与提供常规护理的治疗师不同）的治疗师将接受动机访谈和行为改变技术培训。将收集基线人口统计学数据。将在基线、6 周、12 周和 6 个月（对于早期入组的参与者）时收集患者报告的结果测量，包括健康相关生活质量、日常生活活动、疼痛、社区移动性、跌倒相关自我效能、资源使用、再入院和死亡率。将在 6 周和 12 周时收集运动依从性（6 周和 12 周）和干预可接受性（12 周）。20 名参与者的亚组还将在每个时间点收集 10 天的加速度计数据。
试验结果将通过出版物、演示文稿和社交媒体渠道向患者和公众、卫生专业人员和研究人员传播。
该试验已在 ISRCTN8666443 注册。
3.0。
