Supplementary Material for: Using smartphone TechnolOGy to support an EffecTive Home ExeRcise intervention to prevent falls amongst community dwelling older adults The TOGETHER feasibility RCT.

Introduction
Falls have major implications for quality-of-life, independence and cost to health services. Strength and balance training has been found to be effective in reducing the rate/risk of falls, as long as there is adequate fidelity to the evidence-based programme. The aims of this study were to: (1) assess the feasibility of using the ‘Motivate Me’ and ‘My Activity Programme’ intervention to support falls rehabilitation when delivered in practice (2) assess study design and trial procedures for the evaluation of the intervention.

Methods
A two-arm, pragmatic feasibility randomised controlled trial was conducted with five health service providers in the UK. Patients aged 50+ years eligible for a falls rehabilitation exercise programme from community services were recruited and received either: (1) standard service with a smartphone for outcome measurement only or (2) standard service plus the ‘Motivate Me’ and ‘My Activity Programme’ apps. The primary outcome was feasibility of the intervention, study design and procedures (including recruitment rate, adherence and drop-out). Outcome measures include balance, function, falls, strength, fear of falling, health related quality of life, resource use and adherence, measured at baseline, three and six month post-randomisation. Blinded assessors collected the outcome measures.

Results
24 patients were randomised to control group, 26 to intervention group, mean age 77.6 (Range 62 to 92) years. We recruited 37.5% of eligible participants across the five clinical sites. 77% in the intervention group completed their full exercise programme (including the use of the app). Response rate for outcome measures at six months were 77%-80% across outcome measures, but this was effected by the COVID19 pandemic. There was a mean 2.6 ± 1.9 point difference between groups in change in BERG balance score from baseline to three months and mean 4.4 ± 2.7 point difference from baseline to six months in favour of the intervention group. Less falls (1.8 ± 2.8 vs 9.1 ± 32.6) and less injurious falls (0.1 ± 0.5 vs 0.4 ± 0.6) in the intervention group and higher adherence scores at three (17.7 ± 6.8 vs 13.1 ± 6.5) and six months (15.3 ± 7.8 vs 14.9 ± 7.8). There were no related adverse events. Health professionals and patients had few technical issues with the apps.

Conclusions
The motivational apps and trial procedures were feasible for health professionals and patients. There are positive indications from outcome measures in the feasibility trial and key criteria for progression to full trial were met.

引言
跌倒事件对患者的生活质量、独立生活能力以及医疗服务成本均具有显著负面影响。研究表明，只要严格遵循循证方案开展训练，力量与平衡训练可有效降低跌倒发生率与跌倒风险。本研究旨在达成两大目标：（1）评估"Motivate Me"与"My Activity Programme"两款干预工具应用于临床跌倒康复支持的可行性；（2）评估用于该干预措施评估的研究设计与试验流程合理性。

研究方法
本研究联合英国5家医疗服务机构开展了一项双臂实用性可行性随机对照试验（pragmatic feasibility randomised controlled trial）。研究招募了年龄≥50岁、符合社区跌倒康复训练项目准入标准的患者，将其随机分为两组：（1）常规服务组，仅使用智能手机进行结局指标测量；（2）干预组，在常规服务基础上搭配"Motivate Me"与"My Activity Programme"两款应用程序。本研究的主要结局指标为干预措施、研究设计与试验流程的可行性，包括招募率、干预依从性与脱落率。结局指标涵盖平衡能力、身体功能、跌倒事件、肌肉力量、跌倒恐惧、健康相关生活质量、资源利用情况与干预依从性，分别于随机化基线、随机化后3个月与6个月进行测量。采用盲法评估者收集所有结局指标数据。

研究结果
共24名患者被随机分配至对照组，26名分配至干预组，受试者平均年龄为77.6岁（年龄范围62~92岁）。5个临床中心共招募到符合资格受试者的37.5%。干预组中有77%的患者完成了全部训练项目（含应用程序的使用）。各结局指标在随机化后6个月的应答率为77%~80%，但该数据受新冠疫情（COVID-19）影响。从基线至随机化后3个月，两组伯格平衡评分（BERG Balance Score）变化的组间均值差异为2.6±1.9分；从基线至随机化后6个月，组间均值差异为4.4±2.7分，均以干预组更优。干预组的跌倒发生次数（1.8±2.8 vs 9.1±32.6）与损伤性跌倒次数（0.1±0.5 vs 0.4±0.6）均少于对照组，且在随机化后3个月（17.7±6.8 vs 13.1±6.5）与6个月（15.3±7.8 vs 14.9±7.8）的干预依从性评分均高于对照组。未发生与干预相关的不良事件。医疗专业人员与患者在使用两款应用程序时仅遇到少量技术问题。

研究结论
两款激励类应用程序与试验流程均可被医疗专业人员与患者顺利实施，具备可行性。本可行性试验的结局指标显示出积极的干预效果，且已满足推进至全规模试验的关键标准。